DRAFT OF
05/11/2006
Federal Law Review
Background
A majority of states and jurisdictions assess the pharmacy law competencies of individuals applying for a pharmacist license through administration of the National Association of Boards of Pharmacy’s (NABP) Multistate Pharmacy Jurisprudence Examination™ (MPJE™). The MPJE uses questions that are applicable to all jurisdictions through the federal laws but also tailors questions to the individual states and territories. The states that do not administer the MPJE use examinations that are developed by each individual state. However, even these examinations almost always include questions dealing with federal laws, especially controlled substances. As such, no matter where the exam is taken, licensure applicants must be proficient in both state and federal laws pertaining to pharmacy. In any event, candidates must take a separate law exam for each state in which they are seeking licensure.
License applicants should consult the competency statements provided by NABP with the MPJE materials as a starting point for determining which subjects should be studied. This advice applies to candidates in non-MPJE states as well, because the subject matter of pharmacy law is similar in all jurisdictions. The MPJE competency statements and other study tools may be accessed at the NABP Web site: http://www.nabp.net. There is a wealth of information about the examination located there and applicants should take advantage of those materials.
The exam consists of 90 multiple choice questions; however, 30 of those questions will not be counted for the purpose of calculating your score. These “pre-test” questions are dispersed throughout the examination and there is no way that candidates can tell which questions are counted and which ones are not. Candidates will be given two hours to complete the exam. If a candidate answers fewer than 77 questions, the exam will not be scored. Candidates should try to answer all 90 questions because there is a penalty for not answering questions. No two exams are the same because there is a large block of test questions. The difficulty of subsequent questions depends on whether or not the prior question was answered correctly. Candidates will not know whether a question was answered correctly while taking the exam or afterwards because only scores are reported. The minimum passing score is 75.
Unlike the NAPLEX exam, scores for the MJPE are not transferable between the states or jurisdictions that use the MPJE because the MPJE is uniquely tailored for each state.
The law exam is administered as a “computer adaptive” format. This means that a candidate cannot go back and forth between questions and change an answer after the question is finished. This testing format is very different from traditional paper and pencil exams commonly used in academic settings. Please consult the NABP materials for further explanation of the test-taking procedures.
It is also important to know the competencies the MJPE is attempting to assess. In its Registration Bulletin, the NABP states: “The MPJE Competency Statements serve as a blueprint of the topics covered on the examination. They offer important information about the knowledge, judgment, and skills you are expected to demonstrate while taking the MPJE. A strong understanding of the Competency Statements will aid you in your preparation to take the examination.”
The following competency statements and weights are from the 2006 NABP Registration Bulletin for the NAPLEX/MJPE:
Area 1 Pharmacy Practice (Approximately 78% of Test)
1.01 Identify the legal responsibilities of the pharmacist and other pharmacy personnel.
1.02 Identify the requirements for the acquisition and distribution of pharmaceutical products.
1.03 Identify the legal requirements that must be observed in the issuance of a prescription/drug order.
1.04 Identify the procedures necessary to properly dispense a pharmaceutical product, including controlled substances, pursuant to a prescription/drug order.
1.05 Identify the conditions for making an offer to counsel or appropriately counsel patients, including the requirements for documentation.
1.06 Identify the requirements for the distribution and/or dispensing of prescription anad/or non-prescription pharmaceutical products, including controlled substances.
1.07 Identify the proper procedures for keeping records of information related to pharmaceutical products, including requirements for protecting patient confidentiality.
Area 2 Licensure, Registration, Certification, and Operational Requirements (Approximately 17% of Test)
2.01 Identify the qualifications, application procedure, necessary examinations, and internship requirements for licensure, registration, or certification of individuals engaged in the manufacture, storage, distribution, and/or dispensing of pharmaceutical products (prescription and nonprescription).
2.02 Identify the requirements and application procedure for the registration, licensure, certification, or permitting of a practice setting or business entity.
2.03 Identify the operational requirements for the registration, licensure, certification, or permitting of a practice setting (e.g., space, equipment, advertising and signage, automated equipment, storage, and security).
Area 3 Regulatory Structure and Terms (Approximately 5% of Test)
3.01 Identify the purpose of, and the terms and conditions found in, the laws and rules that regulate or affect the manufacture, storage, distribution, and dispensing of pharmaceutical products (prescription and nonprescription), including controlled substances.
3.02 Identify the authority, responsibilities, and operation of the agencies or entities that enforce the laws and rules that regulate or affect the manufacture, storage, distribution, and dispensing of pharmaceutical products (prescription and nonprescription), including controlled substances.
This Heading will discuss topics generally associated with competencies addressed by the MPJE and other common sources of pharmacy law evaluations. In terms of the competency statements listed above, the majority of the materials presented here will focus on Area 1 because many of these topics are the subject of federal regulation. Areas 2 and 3 are governed primarily by state laws. Only a few of the most common issues addressed by state laws are considered. Because there are many variations in state laws, you will need to consult legal resources tailored to the particular state in which you seek your licensure.
In adopting this approach, we presume that readers have already completed a course dealing with pharmacy law issues and are familiar with the basic methods used to regulate pharmacy practice. We also presume that readers know the basic terminology pertaining to pharmacy law as well as the procedures used to adopt and enforce pharmacy regulations. You should consult basic pharmacy law textbooks when you need more detailed information other than what is provided here. NABP recommends using reference materials such as “Facts and Comparisons’ Pharmacy Law Digest or the United States Pharmacopeia Dispensing Information or Approved Drug Products and Legal Requirements, which contain federal statutes and regulations applicable to the several states.” NABP also suggests that additional information may also be obtained from the state board of pharmacy where you are seeking licensure.
In analyzing any legal question, keep in mind that the regulation of drugs and many aspects of pharmacy practice are subject of both state and federal laws. Because of this concurrent (duel) jurisdiction, there may be significant differences between the laws insofar as the obligations of a pharmacist are concerned. Usually, pharmacists will follow the stricter law, i.e., the law requiring a higher level of behavior. For example, federal law requires that pharmacies maintain some controlled substances records for two years; many states require pharmacies to keep these same records for five years. In those locations, the pharmacy would have to adhere to the longer period for maintaining these documents.
It is also useful to remember that there are differences in the organizational demands and goals of the various agencies that regulate drugs. The Food and Drug Administration (FDA), a section within the Health and Human services Department is charged with determining if drugs are safe and effective and whether they should be available with or without a prescription. It is staffed by health care practitioners that approach drug quality and safety from a scientific point of view. The Drug Enforcement Agency (DEA), on the other hand, is primarily concerned with whether a substance (remember this agency deals with things that are not necessarily drugs) is subject to abuse or capable of causing physical or emotional addiction. Instead of a scientific approach, this agency uses a police mentality to make its determinations. In most states a Board of Pharmacy or a similar agency regulates all aspects of drugs, controlled substances and the practice of pharmacy.
It may also be useful to think of federal laws as those that apply to drugs, such as their manufacture, labeling and distribution while state laws apply primarily to the practice of pharmacy, i.e., what a pharmacist does. This is, of course, a simplistic explanation of a complex set of interactive laws. But it is a useful tool, like keeping in mind the differences between the trees and a forest
Definitions, Abbreviations, and Explanations
Think of studying pharmacy law as learning a new language. Understanding words and phrases in a foreign language requires knowledge of how those words and terms are defined. In studying pharmacy law, it is most helpful to start with common legal definitions. For example knowing the difference between a “drug,” a “food,” a “dietary supplement,” and a “cosmetic” will determine which records, if any, a pharmacist must keep or what labels must be provided when “distributing” or “dispensing” these various “articles.” It is also important to know what the terms “label” and “labeling” mean. Likewise, it is helpful to know which activities are encompassed in the legal notion of the “practice of pharmacy” in order to understand what is meant by a statute that contains a statement such as “No one is allowed to engage in the practice of pharmacy unless properly licensed.” Equally important, it is necessary to understand what “delegation” means to determine what acts, tasks, or functions normally associated with the practice of pharmacy may be delegated by a pharmacist to non-pharmacist supportive personnel including pharmacy interns and technicians. Some of these terms, such as “drug” and “food,” are defined primarily by federal laws like the Food Drug and Cosmetic Act (FDCA). Others, such as the “practice of pharmacy,” will be determined by state law. It is also important to understand the context might change the definitions of these words or phrases. For example when one refers to a “label” the content included thereon will differ if the term is used in connection with a manufacturer’s label, the pharmacy’s dispensing label or a patient-package label
Another useful review activity is to consider common abbreviations associated with pharmacy laws. Knowing what NDA, ANDA, SNDA, DEA, DESI, FDA, USP/NF, and similar abbreviations stand for may make studying much easier. Recognize that the context in which these abbreviations are used may also change the meaning. For example an NDA might refer to a “new drug application” or a “new drug approval” depending on the status a drug is in during an FDA review.
Obviously, a review Heading of this size cannot list definitions and abbreviations for all key terms from all jurisdictions. Furthermore, it is important to note that several of these terms may have additional or different definitions under other federal or state laws. Some of the more important terms and abbreviations (in alphabetical order) associated with federal laws include:
Adulterate: A drug is deemed to be adulterated when it is produced under conditions that are not sanitary. Any drug produced under conditions that violate the CGMPs (discussed below) will be deemed adulterated. Drugs that are listed in any of the official compendia (e.g., USP/NF, defined further below) but fail to meet the purity or strength standards established by the compendia will also be deemed adulterated. Students sometimes mix up the concepts of adulteration and misbranding (see below). Adulteration deals with the quality of the drug itself. Misbranding deals with the packaging and labeling of the drug. Note that drugs may be both adulterated and misbranded under certain conditions.
Adequate directions for use: directions under which the layman can use a drug safely and for the purposes for which it is intended. All OTC drugs must bear a label containing adequate directions for use. For Rx-only drugs, the manufacturer or distributor's labeling must include adequate directions for use up and until drugs are dispensed pursuant to a prescription when the labeling requirements change. The directions must include a statements of all conditions, purposes, or uses for which such drug is intended, quantity of dose, frequency of administration, duration of use, time of administration (in relation to time of meals, time of onset of symptoms, or other time factors), route or method of administration and preparation for use (shaking, dilution, adjustment of temperature, or, other manipulation or process).
ANDA: Abbreviated New Drug Approval (or Application). This is the process by which a generic manufacturer of a drug already on the market with an NDA obtained by the innovator company obtains pre-market approval from the FDA. In order to have an application for an ANDA approved, the applicant must prove that the generic active drug component is the exact same chemical entity as and is bioequivalent to the innovator product. The generic company is not required to submit safety and efficacy data because that evidence is already on file from the innovator company.
CGMP (or GMP): Current Good Manufacturing Practices (or just
Good Manufacturing Practices). These are FDA regulations that dictate the
conditions under which all drugs are produced in the
Cosmetic: Something that is intended to be rubbed, poured, sprinkled, sprayed on, introduced into, or applied to the human body for purposes of cleaning, beautifying, or promoting human attractiveness. Soap is excluded from the definition.
DEA: Drug Enforcement Administration. This is a division of the Department of Justice. It is responsible for administering and enforcing the Controlled Substances Act.
DESI: In 1968 the FDA established the Drug Efficacy Study Implementation program to implement recommendations of the National Academy of Sciences investigation of effectiveness of new drugs that were marketed between 1938 and 1962. Recall that drugs on the market before 1938 were exempted from having to prove they are safe. Drugs put on the market after 1938 had to obtain the pre-market approval of the FDA through the NDA process. The efficacy requirement did not go into effect until 1962 after which manufacturers had to prove that new drugs were both safe and effective. For drugs put on the market between 1938 and 1962, manufacturers had to only prove there drugs were safe. The DESI program was established to provide a mechanism for the federal government to establish evidence as to whether or not the these groups of drugs were also efficacious for intended purposes.
Dietary supplement: An item other than tobacco that is intended to supplement the diet and contains a vitamin, mineral, herb or other botanical ingredient, or an amino acid, or is a dietary substance taken by humans to supplement total dietary intake. The definition also includes many other items that are not likely the topics of license exams.
Dispense: The act of a pharmacist preparing a medication for a patient pursuant to a prescription issued by a licensed practitioner and delivery of that medication to the patient or a patient caregiver.
Distribute: In pharmacy this term means the act of transferring a drug by means other than dispensing between individuals or persons who are licensed or registered to handle the drug. For example, a physician might wish to purchase a office supply of a prescription-only medication directly from a pharmacy. The act of taking the drug out of the pharmacy’s inventory and selling it to a physician’s office constitutes distribution, not dispensing.
Drug: An item listed in the United States Pharmacopeia/National Formulary (USP/NF, see below) or the Homeopathic Pharmacopeia of the United States, an item intended for use in the diagnosis, cure, mitigation, treatment of prevention of disease in humans or other animals, an item (other than food) intended to affect the structure or function of humans or other animals. This includes components of any of these listed items.
FDA: Food and Drug Administration. This is a division of the Department of Health and Human Services (HHS) responsible for administering and enforcing the FDCA and its amendments. Note that the FDA has jurisdiction over the distribution of food, drugs, and cosmetics in interstate commerce. It has limited authority over dietary supplements. More importantly, the FDA has authority to regulate the manufacture, research, labeling, and distribution of all drugs including those available over the counter (OTC) and by prescription only (federal legend drugs). It also has authority to regulate the marketing of prescription-only drugs. The FTC (Federal Trade Commission, see below) regulates most of the advertising claims for OTC drugs and several aspects of the advertising of dietary supplements.
FDCA (sometimes abbreviated in other texts as “FD&CA”): The Food Drug and Cosmetic Act. This law, originally enacted in 1938, has been amended several times over the years. References to the FDCA may be to the whole Act, as amended, or may be only to portions of the Act or specific Amendments. For example, as explained in more detail below, the PDMA amended the Act in 1987 and affected the distribution of prescription-only drugs and drug samples. The Food and Drug Administration Modernization Act (FDAMA) was adopted in 1997 as an amendment to the FDCA and affects many FDA activities. Readers should take care in understanding the context under which references are made to any of these acts and amendments so as to avoid confusion.
Food: An item that is used for food or drink in humans and other animals. Chewing gum is always a food. Note that gum may be used as a drug delivery device as with nicotine gum but the gum itself is still a food.
FTC: Federal Trade Commission. This agency has authority to investigate and prevent unfair trade practices including false and misleading advertising of OTC drugs and dietary supplements. For all intents and purposes, the FTC does not regulate the advertising or promotion of prescription-only drugs; this function is performed by the FDA.
Grandfather: This term, in law, does not refer to the kindly old gentleman that gave you candy and money when your parents were not looking. Instead, when it comes to use in context with the FDCA, it is used to denote drugs that were on the market before 1938 when the "new drug approval" (NDA) process was adopted to require manufacturers to get pre-market approval from the FDA by showing that the drug is safe for its intended purposes. The "grandfather" provision exempts pre-1938 drugs from the NDA requirement. Had this provision not been written into the law there would have been a great deal of protest from manufacturers who were allowed to market their pre-1938 drugs without very much government regulation. This probably would be found in violation of the United States Constitution's prohibition about enacting "ex post facto" laws. It is very unlikely that the MPJE would ever ask about anything so esoteric as ex post facto laws.
GRAS: a tem used by the FDA for a vast variety of things that it regulates when those things are Generally Recognized as Safe.
Label: Written or printed material on the immediate container of an item such as a drug. In pharmacy practice, this usually means the written matter that appears on the outside of a commercial or pharmacy bottle containing drugs.
Labeling: Includes labels and any other written material on or accompanying an item. In pharmacy, this means the manufacturer’s package insert and anything else that might accompany a drug. It also includes patient package inserts for the few drugs (e.g., oral contraceptives and estrogen products) that require them. The FDA must approve the content and appearance of all labels and labeling. Drugs that have improper labels or labeling are considered misbranded.
Misbrand: A drug is considered misbranded when the labeling is false or misleading or when a label that is required by law is not provided. Drugs that are packaged without conforming to the child-resistant safety restrictions established by the Poison Prevention Packaging Act PPPA (discussed below) are also considered misbranded.
NDA: New Drug Approval or New Drug Application. A
manufacturer or distributor that wishes to introduce a new drug must obtain
approval of its application before the drug may be sold (i.e., pre-market
approval) in this country. In order to obtain an NDA, the applicant must prove
that the drug is both safe and effective for its intended purpose. Evidence is
gathered from testing the drugs in humans. Before human testing may begin, the
applicant must obtain an
New Drug: Any drug that has not previously been marketed in
the
SNDA: Supplemental New Drug Approval (or Application). When the maker of a drug already on the market with an NDA wishes to make new claims for the drug it must seek approval from the FDA to change the approved labeling. This is done through the SNDA process whereby the applicant provides evidence that the drug is safe and effective for the newly claimed uses.
USP/NF: The United States Pharmacopeia–National Formulary is a book of pharmacopeial standards that contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements. Drugs that do not conform to these compendial standards may be deemed adulterated, misbranded or both.
The FD&CA
The FDCA
EDITOR: PLEASE CHANGE THE HEADING OF THIS SECTION AND REMOVE THE "&" FROM THE TITLE. THANKS.
There are only a few historical facts that pharmacists need
to know about regulations of drugs at the federal level. While the MPJE does
not ask questions about when an amendment to the FDCA was passed into law or
what the popular name of an amendment is, it may be easier to understand
current regulations if a few drug law developments are kept in mind. There is
one exception: know that the FDCA became law in 1938. This date is critical to
determine which laws apply to specific drugs. For example, not every drug on
the market in the
The FDCA was amended in 1951 by the "Durham-Humphrey Act" to establish two classes of drugs. OTC drugs are those that are considered safe to use according to the labeled directions. OTC labeling must include “adequate directions for use” rendering them safe to use without further medical directions. Drugs that are not safe for use without medical direction are limited to sale to a patient only pursuant to a prescription issued by someone who is allowed to prescribe under state law. (Note that federal law defers to the states for determining who is allowed to prescribe.) These items are known as “prescription only” or “federal legend” drugs. Up until very recently, the commercial container from the manufacturer or distributor of these drugs had to bear a label stating, “Caution: Federal law prohibits dispensing without a prescription.” This phrase was called the “federal legend.” The Food and Drug Administration Modernization Act of 1997 (FDAMA) amended this mandate; now federal legend drugs must be labeled, at a minimum, with the designation “Rx Only.” In effect, this amendment changed the content of the “federal legend” to “Rx Only.”
Federal legend drugs are exempt from the “adequate directions for use” labeling requirements because they are otherwise properly labeled when they are dispensed pursuant to a prescription. Under federal law, a pharmacy label of a dispensed prescription must contain the name of the prescriber, the serial number (more commonly known as the prescription number), the name and address of the dispensing pharmacy, and the date the prescription was originally written, dispensed, or most recently refilled. This amendment also provides that federal legend drugs may be refilled according to the prescriber’s directions. In addition, the name of the patient and any directions for use, including precautions must also appear on the pharmacy label if this information appears on the prescription. In other words, the patient’s name and directions for use are not always required on the pharmacy label of a prescribed drug under federal law. It is important to note that this provision applies only to federal-legend non-controlled substances. As discussed below, labeling requirements for prescription-legend controlled drugs that are dispensed from a pharmacy do require this information. Be aware, however, that every state has additional labeling requirements for dispensed medications. In addition to the patient’s name and directions for use, the vast majority of states also require the drug name to appear unless there are special circumstances. If questions arise as to the labeling mandates for a dispensed drug, responses should include considerations for both state and federal law.
The "Kefauver-Harris Amendment of 1962" (also called the "Drug Efficacy Amendment") added a section to the FDCA to mandate that manufacturers of drugs submit proof that a new drug is effective in addition to being safe, as mandated in the original 1938 Act. After implementation of this Amendment, manufacturers had to prove that new drugs are both safe and effective. Drugs placed on the market between 1938 and 1962 must also be shown to be effective; however, for this category of drugs, the FDA established the "Drug Efficacy Study Implementation" (DESI) program. Most, if not all, drugs subject to the DESI program have been removed from the market where evidence is not available to substantiate that they are effective.
This amendment also established the CGMPs that specify the
conditions under which all drugs made in the
The FDCA was amended again in 1984 by the "Drug Price Competition and Patent Term Restoration Act" (also known as the "Waxman-Hatch Amendment") to exempt generic drug manufacturers or distributors from having to submit original safety and efficacy evidence for drugs already subject to an NDA from the innovator manufacturer. The generic company must prove that the generic drug is bioequivalent to the innovator drug. Successful applicants are awarded approval of an ANDA from the FDA. This event gave rise to the FDA’s practice of rating the equivalency of drugs that are listed in the so called “Orange Book,” which is formally known as the "Approved Drug Products with Therapeutic Equivalence Evaluations. The online version is often referred to as the "Electronic Orange Book" (http://www.fda.gov/cder/ob/default.htm). For applicants living in jurisdictions that use the Orange Book as a guide for pharmacists in making "generic substitution" (also called "drug product selection" or “DPS”) decisions, it is important to recall that drugs in the listings with a designation in the first letter or the equivalency rating (the FDA assigns two alphabetical letters for each listed drug) as an "A" are deemed to be equivalent with the innovator companies product. If the first letter is a "B," the FDA considers the generic drug to NOT be equivalent with that of the innovator company.
It is important to know that not all generic and innovator drugs are listed in the Orange Book. Only those that have an existing NDA are listed. Drugs that were "grandfathered" from the safety evidence requirement of the 1938 act are not included in the Orange Book even though there may be generic products available. Note also that some states use the Orange Book as a reference for drug product selection or generic substitution activities as well as for formulary development.
The "Prescription Drug Marketing Act (PDMA) of
1987" amended the FDCA to implement controls on the distribution of
prescription drugs, prescription drug samples, and prescription drug coupons.
The PDMA prohibits drug manufacturers and their representatives from
distributing drug samples to physicians unless the physician makes a request in
writing. Under federal law, hospital pharmacies may receive and maintain drug
samples for and on behalf of prescribers when the prescriber has made a proper
request. Community pharmacies are not allowed to have any drug samples in stock
or on hand. The PDMA also prohibits, with a few rare exceptions, manufacturers
and distributors from importing drugs into the
Another important amendment to the FDCA is the Dietary Supplement Health and Education Act of 1994. This act often referred to as the DSHEA law carves out a regulatory scheme for dietary supplements separate and apart from drug regulation. The act severely limits the FDA from having jurisdiction to regulate many aspects of the marketing of dietary supplements. Instead, the FTC monitors advertising for dietary supplements to insure that no false or misleading claims are made by the manufacturers or distributors. Effects of the DSHEA law are discussed in more detail in the section dealing with distinguishing between food, dietary supplements, cosmetics and drugs.
Another amendment to the FDCA is the "Food and Drug Administration Modernization Act (FDAMA) of 1997." This act has far-reaching effects on how the FDA conducts its mandates for overseeing the marketing and distribution of drugs. As mentioned above, this is the Act that changed the traditional federal legend that has to appear on the manufacturer or distributor labels of drugs that are restricted to distribution pursuant to a prescription; following implementation, the drugs must bear a label that, at a minimum, states “Rx Only.” This Act also eliminated the need for a warning label on certain habit-forming drugs. It also specifies that drugs and drug products compounded by pharmacists are exempt from FDA regulation under specified circumstances. This provision was included because the FDA had, in a few instances, attempted to restrict pharmacist compounding on the notion that the compounded product was a new drug subject to NDA and CGMP requirements. The United States Supreme Court ruled in 2002 that the FDAMA statute that restricts compounding to pharmacies that do not solicit or advertise this service is unconstitutional. Further discussion of the implications of this decision is addressed below in the section entitled “Compounding Prescription Drugs.”
There have been numerous other amendments to the FDCA over the years. The above descriptions only highlight some of the more important provisions that pharmacist licensure candidates should be aware of.
Distinguishing Foods, Dietary Supplements, Cosmetics, and Drugs
EDITOR NOTE: CHANGE THE TITLE OF THIS SECTION TO:
DISTINGUISHING BETWEEN FOODS, DIETARY SUPPLEMENTS, COSMETICS AND DRUGS
In the language of the FDCA, the things we put on, into or around us are “articles” that fall into four distinct classifications: food, dietary supplements, cosmetics or drugs. The key to understanding whether an article falls into one or another of the named categories is to focus on the intent of the manufacturer or marketer of the item. Intent is most often determined by looking at claims that are made for the item. For example, if the manufacturer of a cereal that contains naturally occurring oat-bran advertises that this cereal builds strong bones, then the cereal would likely be classified as just a food. If that manufacturer advertises that this product helps control cholesterol, it might be viewed as either a food or a dietary supplement. But if that manufacturer advertises the cereal will prevent heart attacks by lowering cholesterol levels, the FDA may view this claim as one for prevention of a disease and, therefore, deem this to be a drug claim.
There are serious ramifications in classifying an item as a drug or one of the other categories. If an item is a drug, it is subject to the whole array of FDA regulations including the need for a pre-market NDA approval, proof that the drug is safe and effective, is manufactured by an FDA registered manufacturer in accordance with the CGMPs, and that its labeling is proper and approved by the FDA. If the drug may be sold without a prescription, it must be labeled with “adequate directions for use” and packaged in accordance with federal anti-tamper proof and child-resistant regulations. Additional storage and labeling mandates apply to prescription drugs dispensed by a pharmacist. If the drug is packaged with the labeling required by the FDA for Rx-only drugs, the pharmacy label will replace the adequate directions for use requirement. A pharmacist who sells any drug, OTC or Rx-only, that does not comply with all legal mandates is subject to severe disciplinary sanctions including criminal prosecution. Improperly labeled drugs will be deemed misbranded under the FDCA. Drugs produced in violation of the CGMPs are considered adulterated under the federal law.
In comparison to drugs, cosmetics are subject to very few regulations. Foods and food supplements are subject to some labeling and packaging requirements at both the state and federal levels. However, with rare exceptions, pharmacists need not be concerned with these regulations. Perhaps the more difficult distinction, in terms of regulations, involves dietary supplements and claims made for their usefulness. There is a fine, and often vague, line between a claim for a dietary supplement and a claim that would cause such an item to be classified as a drug. While readers should be aware of these issues, it is unlikely that detailed questions would appear on a licensure exam because so many questions are unsettled and controversial. Readers should, however, recognize that dietary supplements, a classification that includes vitamins, herbs, botanicals, and anything else intended to supplement the diet, are exempt from most FDA scrutiny, including the need for an NDA and compliance with the CGMPs. Regulations adopted by the FDA do attempt to define what kinds of labeling and other claims will render a dietary supplement to be considered a drug. The FTC does review claims made for dietary supplements to make sure the claims are truthful and not misleading.
The 1994 DSHEA law establishes dietary supplements as a
category distinct and separate from foods or drugs. Unlike drugs that must be
pre-approved for the
The most controversial part of the DSHEA law is its
permission for dietary supplement makers to make certain function-structure
claims for their products. It is often difficult to tell whether a manufacturer
or distributor of a product is making a claim that the product does something
to cure, treat or mitigate a disease (which would classify the product as a
drug) or is merely making a claim that the product will enhance nutrition
(which would result in a dietary supplement categorization for the product).
When a dietary supplement manufacturer makes a function-structure claim on the
labeling of the product, the label must also carry a disclaimer stating: “This
statement has not been evaluated by the Food and Drug Administration. This product
is not intended to diagnose, treat, cure or prevent disease.” The manufacturer
or distributor of a product must notify the FDA of its actions within 30 days
of putting the product on the market in the
While it is not likely that the MPJE would ask questions of a pharmacist licensure applicant, there is a fifth category of articles regulated to some extent by the FDA. Veterinary Pharmaceuticals, that are drugs intended for animals other than humans must also meet safety and efficacy standards.
Poison Prevention Packaging Act (PPPA)
The PPPA requires that all oral drugs intended for use in humans be placed in “special packaging” that is “child-resistant” as described in regulations adopted by the Consumer Products Safety Commission (CPSC). The intent of these laws is to prevent the poisoning of young children from common household products including most drugs. In community pharmacy practice, this means that oral dosage forms of dispensed drugs must be delivered to the patient (or caregiver) with child-resistant safety caps irrespective of whether the drug is intended for adult or pediatric patients and irrespective of whether or not there are children present in the patient’s home. Note that these regulations are mandated separate and apart from FDA packaging and labeling requirements. However, the FDA does consider drugs sold in packaging that does not conform to PPPA requirements to be misbranded. The poison prevention act does not apply to drugs dispensed to institutional or hospital patients.
A prescriber or patient may request that child-resistant packaging not be used. It is important to note that while the request does not have to be in writing under the PPPA, pharmacists should always note the request for non-child-resistant packaging has been made on the prescription or in the patient profile record.
There are 17 drug and drug categories that are expressly exempted from the mandates of this law. Pharmacist licensure applicants should know the drugs and drug categories that are exempted from the child-resistant packaging regulations. Only the most common are listed here: sublingual dosage forms of nitroglycerin, sublingual and chewable forms of isosorbide dinitrate in 10-mg or less strengths, progesterone or estrogen oral contraceptives dispensed in packages for cyclical administration, sodium fluoride when sold in containers with 264 mg or less per package, prednisone tablets in packages containing no more than 105 mg, conjugated estrogen tablets in packages of no more than 32 mg, and erythromycin ethylsuccinate tablets in packages containing 16 g or less of erythromycin. Readers should consult pharmacy law texts for a listing of drugs exempt from this law. Note that the exceptions are narrowly construed. For example, the exception applies to sublingual nitroglycerin tablets, not to any other forms. Note also that the Act applies only to oral dosage forms of drugs. Therefore, creams, pastes, injectables, and patches are not covered by this law.
The law also prohibits reusing child-resistant packaging; glass containers may be reused only if a new safety closure is provided at the time the glass container is reused. In practical terms, this means, for the most part, that pharmacists cannot reuse patient vials for oral prescription drugs that are refilled. Essentially, commercial containers of federal legend drugs distributed to a pharmacy do not have to contain child-resistant closures. Exceptions exist when the commercial container is intended to be relabeled by a pharmacy and sold or otherwise transferred directly to a patient; in these cases, the commercial container must include child-resistant packaging.
Note also that the Act applies to OTC drugs. Regulations allow manufacturers and distributors of OTC drugs to package one size of a product that does not conform to the child-resistant requirement as long as the label clearly states that the product is not in child-resistant packaging.
Anti-Tampering Act
Tamper-resistant packaging is required for many consumer products, including most OTC drugs, cosmetics, and medical devices. Contact lens solutions and lubricants are also subject to these restrictions. Dentifrices, dermatological products, lozenges, and insulin are exempted from the regulations. Prescription drugs dispensed from a pharmacy are also exempted.
Tampering is defined as an intentional act of altering a product to make objectionable and unauthorized changes. Anyone charged with tampering with a product is subject to criminal charges.
Three federal agencies have jurisdiction to enforce anti-tampering regulations. The Federal Bureau of Investigation (FBI), the United States Department of Agriculture and the FDA each have authority to regulate products that must be marketed with these preventative measures. The FDA regulation applicable to OTC drugs requires a statement on the label indicating that it is packaged with tamper-resistant materials.
Other Packaging Requirements
Commercial containers of drugs must meet federal standards for maintaining the integrity of the drugs during distribution throughout the marketing chain. For all federal legend drugs, the manufacturers’ labeling (package insert) must contain a statement indicating to a pharmacist what kind of container a particular drug should be dispensed in to maintain its identity, strength, and purity. For the most part, the FDA regulations defer to standards established by the USP/NF for determining adequate container standards. Drugs that are not packaged in accordance with these standards are considered misbranded.
Drug Recalls
Although the FDA does not have inherent authority to order a drug manufacturer or distributor to remove an adulterated or misbranded drug from the market, the FDCA prescribes the procedures followed by the FDA to obtain court-ordered recalls or seizures. Of course, a company may voluntarily engage in a product recall if it believes that a product is adulterated or misbranded. The law establishes three categories of recalls designed to alert practitioners and the public as to the level of concern that ought to be raised about the recall. A Class I recall indicates that there is reason to believe use of the drug will cause serious adverse health consequences or even death. A Class II recall means that use of the drug may cause medically reversible consequences but the likelihood of serious adverse results is remote. A Class III recall means that use of a drug will not likely cause adverse health reactions. The manufacturer or distributor of a recalled drug is responsible for notifying the organizations that received the drug. The FDA is responsible for notifying the public about drug recalls.
Some students of pharmacy law confuse the class of drug recall with controlled substances schedules due to the similarities in the numbering system. A simple way to recall the order of severity of a drug recall follows the kind of categorization for controlled substances. A schedule I controlled substance has the highest level of concern because of the addiction potential of a drug in this class. A class I drug recall is the one where serious harm or death might result. As the numbers increase the level of severity in both groups goes down.
Omnibus Budget Reconciliation Act of 1990 (OBRA-90)
The federal laws discussed up to this point generally deal with the manufacturing, packaging, and labeling of drugs and do not directly impact the practice of pharmacy as such. This is partly because the federal government does not have direct authority to regulate pharmacy practice. This right is, at least theoretically, reserved to the states. The law, commonly known as OBRA-90, is somewhat of an exception to this notion because it does mandate certain actions by pharmacists when dispensing drugs to certain patients. This law has much more impact because the vast majority of states have enacted provisions to make the OBRA-90 requirements apply to all patients. Readers will have to take care to determine the specific laws in the states where licensure is sought. Although it is unlikely to be a question on the MJPE, be aware that OBRA-90 did not take effect until 1993.
OBRA-90, insofar as outpatient pharmacy practice is concerned, requires that pharmacies which participate in Medicaid reimbursement programs perform a drug utilization review before dispensing a drug to a Medicaid-eligible patient. This review requires that a pharmacist make an attempt to obtain and maintain a medication history of the patient and determine that a prescribed drug is both necessary and appropriate for the patient before the drug is dispensed. The pharmacist must also be available to counsel a patient on the proper administration of the drug, its common adverse effects, how to monitor the drug’s use and effectiveness and on proper storage techniques. An offer to counsel may be made by someone other than a pharmacist but the counseling itself must be performed by a pharmacist if the offer is accepted.
As noted, OBRA-90 applies only to outpatient drugs dispensed to Medicaid-eligible recipients. Congress has authority to regulate pharmacy practice to this limited extent because the federal government pays a portion of the Medicaid drug benefit. Medicaid programs are administered by each state but the states are allowed to seek reimbursement from the federal government for approximately 50% of the costs of drugs paid to pharmacies by the state. At the federal level, Medicaid is administered by the Centers for Medicare & Medicaid Services (http://cms.hhs.gov) (formerly known as the Health Care Financing Administration [HCFA]), which is a division within Health and Human Services. OBRA-90 sets forth the conditions that must be met by the state to be eligible for this reimbursement. As a result, every state has enacted some type of law to implement OBRA-90 mandates. However, very few states restricted the OBRA-90 provisions to just Medicaid patients. Instead, nearly every state has, in one form or another, made the drug utilization review process applicable to all patients. In other words, the duty of a pharmacist to offer to counsel all patients on drug use is almost standard across the country. MPJE candidates should consult the laws in the state where pharmacist licensure is sought.
Compounding Prescription Drugs
The FDAMA amendments to the FDCA (discussed in the FDCA
section, above) contain restrictions on when pharmacists are allowed to
compound prescription drugs. Basically, the statute permits pharmacists to
compound drugs pursuant to valid prescriptions so long as the pharmacy does not
solicit compounded prescriptions or advertise to the health care community or
the general public that it performs compounding services. While the history
underlying this policy is interesting, it is not likely to be the subject of
licensure examination questions. Nevertheless it is important for applicants to
understand that the United States Supreme Court struck down the entire
compounding statute as an unconstitutional restriction on freedom of speech.
The decision in Thompson vs.
It should be understood that before the FDAMA amendments went into effect, pharmacists always enjoyed the right to compound drugs for individual patients.The Supreme Court decision, in essence, returns the pharmacy compounding rules to where they were before FDAMA went into law. The FDA, however, issued internal guidelines for FDA Field Offices to use in trying to determine whether a pharmacy has crossed the line between accepted compounding practices and entered into the drug manufacturing role.
Suffice it to say, for examination purposes, that pharmacists may legally compound drugs pursuant to a prescription for an individual patient. The resulting compounded drug product will not be characterized as an unapproved new drug by the FDA under normal circumstances.
Privacy Considerations
Confidentiality of patient records and information is regulated at both the state and federal level. The traditional methods of protecting individual’s privacy concerns are governed primarily by state laws. The approach of the states varies greatly from simple statements like, “Prescription records are not public records”(perhaps the lowest forms of protection) all the way up to “Prescription information and the information learned by a pharmacist in the course of serving a patient are privileged.” Because there is such a diverse set of state laws, MJPE applicants are directed to state laws in the state where pharmacist licensure is being sought.
At the federal level, there is a fairly new set of laws affecting privacy rights. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) required the Health and Human Services Department (HHS) to adopt regulations affecting the confidentiality of patient information. Even though the law was adopted in 1996, its provisions were not fully enacted until 2004.
The essential point to remember is that providers, including pharmacists and pharmacies, must obtain their patients’ consent for uses and disclosures of “protected health information” (PHI) about the patient to carry out “treatment, payment, or health care operations” (TPO). Use of PHI beyond basic TPO requires additional patient authorization. Health care providers must have a documented privacy procedure in place. Each health care organization must train employees so that they understand the privacy procedures and there must be at least one designated individual responsible for seeing that the privacy procedures are adopted and followed.
Providers must also detail security measures for patient records containing individually identifiable health information with a goal of preventing access by those who have no express need for access.
The privacy rules apply to all business associates of providers. For example, a third party hired by a pharmacy to administer prescription claims or process bills would also have to adhere to the same rigid standards applicable to the pharmacy personnel.
Controlled Substances Laws
Study Tips
Significant portions of the MPJE are devoted to assessing licensure candidates’ knowledge of both federal and state controlled substances laws. This is because pharmacists spend significant time complying with the laws regulating the ordering, delivery, storage, recordkeeping, and dispensing of these drugs. It is important to note at the outset that the state and federal governments share concurrent jurisdiction over the regulation of controlled substances. This means that at least two sets of laws need to be considered with reference to controlled substances.
While controlled substances laws have been in place for several years, there are a number of changes that must be taken into account. The DEA published a revised version of The Pharmacist’s Manual in 2004. At the time of printing this text, the most current edition of the Manual is available online at:
http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/index.htm
Do not use any printed or online versions of The Pharmacists Manual prior to the eighth edition as a study reference. If a newer edition of the Manual is published, use the then current version in preparation for the MPJE..
There was one development as of August 2005 that had not been incorporated into the Manual at the time this manuscript was submitted for publication dealing with the DEA’s newly adopted Controlled Substances Ordering System (CSOS). This new ordering system is discussed in the “Distributions of Controlled Substances” section below. The online reference for the CSOS is:
http://www.deaecom.gov/csosmain.html
It cannot be overemphasized that studying from The Pharmacist’s Manual will greatly improve the chance of success in taking the MJPE. This document has been the source of many questions that appear on the examination. Pay attention to the details. By way of example, knowing which DEA form is used for what purpose will be worth points. This controlled substances law review section was compiled from information found in The Pharmacist’s Manual and other information dealing with the DEA as well as the Controlled Substances statutes and regulations.
Many states have adopted modifications that take into account newer practice settings such as group homes and assisted living arrangements and newer technologies such as the internet, online prescribing and electronic signatures. Because of this, it is important for applicants to recognize that some laws may have changed since taking a pharmacy law course in school.
One of the most common issues that students raise is whether they will be asked questions about which drugs are designated as controlled substances and which schedule a drug is placed in. The answer is that the states take a wide variety of approaches to assessing a candidate’s knowledge about these topics. The best advice is that all candidates should know the controlled substance status of the most commonly prescribed and dispensed controlled substances and non-controlled drugs. There are several lists of commonly prescribed drugs online. Try to find a list tailored to the sate in which licensure is being sought.
The other important piece of advice is to pay attention to
drugs that may be placed in different schedules by the DEA as compared with the
state agency that regulates these drugs.
In some cases, a state will place a drug into a higher classification at
the state level compared to the schedule it is assigned by the DEA. For
example, pentazocine (Talwin) is a schedule 4 controlled substance under DEA
regulations. In
Historical Background
While it is highly unlikely that questions would appear on the MJPE about the history of Controlled Substances regulation, preparation for the exam might be easier if just a few historical developments are kept in mind. Congress adopted the federal Controlled Substances Act (CSA) in 1970. The CSA repealed many of the earlier laws and adopted a comprehensive approach to preventing drug abuse. The CSA is sometimes referred to as Title 2 of the Comprehensive Drug Abuse Prevention and Control Act of 1970. The provisions of Title 2 of that Act directly affect pharmacy practice and contain the laws most familiar to pharmacists.
At the time that the CSA was enacted, the FDA was given authority to make the scientific and medical findings that determined whether a drug would be controlled and, if so, how it would be scheduled. That authority changed over time. In 1973, the Drug Enforcement Administration (DEA) was created in the Department of Justice (DOJ), and the Bureau of Narcotics and Dangerous Drugs (BNDD), the agency that had responsibility over these drugs, was abolished. While most current laws have eliminated reference to the BNDD, a few still exist. Where a reference in state or federal law is made to the BNDD, it should be understood to mean the DEA as the successor federal agency. By 1986, the FDA’s role in scheduling drugs was eliminated for the most part and the DEA assumed this authority. The DEA is now the organization that has primary responsibility for promulgating the regulations that implement, interpret, and enforce the CSA. As the head of the Department of Justice, the United States Attorney General is responsible for the DEA operations. The DEA Director reports to the Attorney General.
Goals and Objectives of the CSA
Prevention of drug abuse is one of the CSA’s main goals. It attempts to accomplish this objective in several ways. Record-keeping mandates for manufacturers, distributors, prescribers, and dispensers of controlled substances are designed to reduce the diversion of drugs from the legitimate course of commerce into illegal markets. One of the major impacts of the CSA is the establishment of a “closed” system of distribution that regulates controlled substances from the moment of initial manufacture or harvest until they reach the hands of the “ultimate user.” An ultimate user is a person who lawfully obtains and possesses a controlled substance for his or her own use or use by a member (including an animal) of his or her household. No one is permitted to obtain or possess a controlled substance unless authorized under the provisions of the CSA. Another method of limiting drug diversion is through the requirement of federal registration of persons who handle controlled substances. As used in this law, the term “person” means both individuals and any legally recognized entity including corporations, partnerships, etc.. The registration mandate is discussed in detail below.
Concurrent Jurisdiction
Controlled substances are regulated by both federal and state law. Many state laws require additional or different steps than those demanded by federal laws. For example, federal law mandates that a pharmacy maintain controlled substances records, including prescriptions, for a minimum of 2 years. Many states require a pharmacy to maintain all prescription records for a minimum of 5 years from the date the prescription was filled or last refilled. Using the rule that the stricter law controls, in this instance the pharmacy would have to keep the prescriptions on file for the longer period.
Regulatory Authority
From a Constitutional standpoint, the federal government
exerts jurisdiction over controlled substances under the “interstate commerce”
clause on the presumed notion that these products will cross between state
lines at some point in time. The Attorney General of the
The CSA has been amended many times and the DEA has been given expanded authority. For example, in 1990, the DEA was given authority to regulate anabolic steroids. The agency also regulates precursor chemicals that may be used in producing controlled substances, machinery used in controlled substances manufacturing, and controlled substance analogues.
Schedules
The CSA regulates drugs and other substances by placing
affected chemical entities into a hierarchy of five schedules that vary
depending on the abuse and dependence-producing potential of an individual
substance. It is significant that not all of the substances regulated under the
CSA are drugs. By definition, Schedule 1 controlled substances do not have any
accepted medical use in the
The listing of the various controlled substances in each of the five schedules was initially established by the CSA. The Attorney General, not the DEA director, is given authority to modify the substances in each schedule by adding, deleting, or rescheduling the substances. The schedules are updated and republished on an annual basis. The lists of which drugs are controlled and which schedule each controlled drug is placed in are available from a variety of sources. License applicants are presumed to know the schedule that the common controlled drugs are placed in. States may also place drugs into schedules established by the individual states. For the most part, the state schedules will track the federal schedule. However, there may be some differences making it worthwhile for license applicants to check the law of the state where a license is sought. It should also be useful to review the criteria for placing a substance into a particular schedule.
Schedule 1
(C-I): The drugs and other substances in this schedule are those that have (a) a high potential for abuse; (b) no current accepted medical use in the United States; or (c) there is a lack of accepted safety for use under medical supervision.
Pharmacies, other than those in facilities that are registered for investigative or research uses, should not have any Schedule 1 controlled substances in inventory. Further, physicians are not authorized to prescribe Schedule 1 controlled substances unless registered to perform investigations or do research under approved protocols. Most of the controlled substance analogues of drugs in other schedules, sometimes called “designer drugs,” are classified as Schedule 1 controlled substances. Examples of substances classified in Schedule include heroin, LSD, marijuana, and MDMA (ecstasy).
Schedule 2
(C-II): To be placed in this schedule, the drug or other
substance must be determined to (a) have a high potential for abuse; (b) have a
currently accepted medical use in treatment in the
Schedule 1 and 2 drugs are subject to annual production quotas established by the DEA. The amount of any given drug subject to this regulation that may be manufactured and distributed is determined each year by medical usage in prior years as measured by studies conducted by the HHS. The quotas are revised once annually.
Some examples of Schedule 2 narcotics include morphine, codeine, hydrocodone, and opium, hydromorphone (Dilaudid), methadone (Dolophine), meperidine (Demerol), oxycodone (Percodan) and fentanyl (Sublimaze). Some examples of Schedule 2 stimulants include amphetamine (Dexedrine), (Adderall), methamphetamine (Desoxyn) and methylphenidate (Ritalin). Other Schedule 2 substances include cocaine, amobarbital, glutethimide, pentobarbital and secobarbital.
Schedule 3
(C-III): In order to be placed in this schedule, a drug or
other substance must have (a) less potential for abuse than substances in
Schedule 1 or 2; (b) a currently accepted medical use for treatment in the
Schedule 4
(C-IV): Drugs or other substances in this schedule have (a)
a low potential for abuse relative to substances in Schedule 3; (b) a currently
accepted use for treatment in the
Schedule 5
(C-V): Drugs or other substances in this schedule must have been determined to (a) have a low, but still very real, potential for abuse relative to substances in Schedule 4; (b) have a currently accepted use for treatment in the United States; and (c) lead to a limited physical or psychological dependence potential when abused relative to the substances listed in Schedule 4. Some examples are cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC), Phenergan with codeine).
OTC Schedule 5
It is noteworthy that there are some drugs on the market that are Schedule 5 controlled substances but do not require a prescription. Most of these are either codeine-based cough syrups or paregoric-based anti-diarrheals. This seemingly peculiar inconsistency exists because the FDA, which is part of the HHS, makes the determination as to whether a drug will be available on a prescription-only basis or available without a prescription as an OTC drug. The FDA uses scientific and medical data to make its decisions on the availability and access of drugs. Safety and efficacy are the primary concerns of the FDA. The DEA, which is a totally unrelated government agency, determines whether a substance or drug will be designated as a controlled substance. In addressing this decision, the DEA behaves more like a police agency that is concerned with crime prevention and prosecution of criminal activity. The DEA uses abuse potential and concerns over diversion as the primary factors in making decisions on the control and scheduling of drugs and other substances. In this respect, the jurisdiction of the agencies is separate and does not overlap. As far as Schedule 5 OTC drugs are concerned, the FDA has determined that they are safe and effective for use without the need of medical supervision, while the DEA has concluded that they have a potential, albeit small, for abuse.
Exempt Narcotics
Schedule 5 OTC drugs in the past were referred to as “exempt narcotics.” This archaic but still common term dates back to an exemption from taxation for “Class X” drugs under the 1914 Harrison Narcotic Act. Take care to note how the state where the applicant is seeking licensure regulates non-prescription schedule 5 drugs. Usually, these preparations are available only in a state licensed-DEA registered pharmacy and the pharmacist who sells these medications must keep a record of sales by filing out information about the purchaser and the date of the sale.
It may seem odd upon first consideration that the DEA regulations would permit a retail-based pharmacist to dispense a schedule 2, 3, 4 or 5 controlled substance without a prescription if it has not been designated as a prescription-only substance by the FDA or under the applicable state law and the following procedures are followed:
1. The sale is made by a pharmacist, not by a non-pharmacist employee, even if under the direct supervision of a pharmacist. However, after the pharmacist has fulfilled professional and legal responsibilities, the actual cash, credit transaction or delivery may be completed by a non-pharmacist.
2. The pharmacist must use professional judgment to ensure the medical necessity of the need for the product.
3. Not more than 240 ml or not more than 48 solid dosage units of any substance containing opium, not more than 120 ml (4 fluid ounces), or not more than 24 solid dosage units of any other controlled substance, may be distributed at retail to the same purchaser in any given 48-hour period without a valid prescription.
4. The purchaser is at least 18 years of age.
5. The pharmacist must obtain suitable identification, including proof of age, where appropriate if the pharmacist is not familiar with the purchaser.
6. A bound record book must be maintained containing the name and address of the purchaser, name and quantity of controlled substance purchased, date of each sale, and initials of the dispensing pharmacist. This record book must be maintained for a period of two years from the date of the last transaction and it must be made available for inspection and copying.
Chemical Control Requirements
In recent years, the DEA has recognized that some OTC drug products contain chemical precursors of controlled substances. For example, pseudoephedrine (Sudafed) can be converted to methamphetamine with rudimentary chemical procedures. Ephedrine and phenylpropanolamine are also commonly involved in the clandestine manufacture of controlled substances. These precursors have garnered the attention of regulators at both the state and federal levels. MPJE applicants should review the laws in the states where pharmacist licensure is sought to determine the current regulations for these products.
Persons who handle controlled chemicals need to register with the DEA. Community pharmacies that are registered to receive and dispense controlled substances do not have to register a second time to also carry the affected chemicals unless the pharmacy also engages in the wholesale distribution of the chemicals. DEA Form 510 is used to register as a chemical distributor.
Registration
Most persons (recall that this means both individuals and legal entities including corporations and partnerships) who handle controlled substances must be registered with the DEA unless specifically exempted from federal registration. Manufacturers and distributors of controlled substance drugs are usually required to register on an annual basis. Pharmacies and prescribers (both are often referred to as dispensers or practitioners in the regulations) usually are required to register once every 3 years.
Pharmacists (with the exception of sole proprietorships), pharmacy interns, technicians, and other agents or employees of a properly registered pharmacy do not have to register independently of the pharmacy. These individuals may handle controlled substances without registration so long as they do so while acting in the usual course of business and within the scope of their employment or agency relationship.
This same kind of exemption applies to most other DEA registrants. As such, the employees of manufacturers and distributors need not apply for registration and do not violate the law when possessing controlled substances in the course of their employment. Military officials, including Public Health Service employees, law enforcement agents, and civil defense workers are also exempted from registration so long as their employment situation requires them to handle controlled substances.
Medical students and residents associated with medical institutions including hospitals need not obtain a DEA registration as long as they are working under the supervision of a registered physician and the institution is registered. Physician’s assistants and nurse practitioners (or nurse clinicians) must register as midlevel practitioners in almost all situations.
Separate registrations are required for each individual site where controlled substances are stored or dispensed. Each pharmacy must have its own separate registration and DEA number even if a single corporate entity operates several pharmacies. Thus, if a chain-store owns 100 pharmacies each operating at a separate street address, 100 separate registrations must be obtained. If a hospital or other health care facility operates more than 1 pharmacy at several satellites within the facility only a single registration is necessary so long as the facility operates from a single street address. However, if that same facility operates hospital and several clinic pharmacies at different locations, multiple registrations will be required.
Separate registrations are also required for multiple activities even if they occur at the same location. For example, a large health care facility may manufacture, distribute, and dispense controlled substances. Each activity requires a separate registration. If research is also conducted at the facility, an additional registration is necessary.
A pharmacy applies for a DEA registration on DEA form 224
which is available online in the Pharmacist’s Manual, and may be obtained from
any DEA Field Office, or at the DEA Headquarters in
The DEA requires a pharmacy engaged in co-op buying of controlled substances to also register as a distributor. As a distributor, a pharmacy must meet distributor (wholesaler) security and recordkeeping requirements.
If a DEA registered pharmacy moves locations or the postal address of the pharmacy changes, the pharmacy is responsible for submitting a written request for a new registration certificate from the DEA before the change occurs. The request should be made to the local DEA Field Office. Once the new location is noted by the DEA it will issue new DEA Form 222 (if the pharmacy is still using hardcopy forms to order schedule 2 controlled substances).
A DEA registration may be suspended or revoked, or an
application for renewal or for a change in location may be denied if the DEA
has reason to believe the registrant is involved in the diversion of controlled
substances from legitimate channels into illegal markets. Decisions resulting
in the suspension, revocation or denial of renewals or change of locations are
made by the Attorney General of the
The “inconsistent with the public interest” standard
requires the
1. The recommendation of the appropriate state licensing board or professional disciplinary authority;
2. The applicant's experience in dispensing or conducting research with respect to controlled substances;
3. The applicant's conviction record under federal or state laws relating to the manufacture, distribution or dispensing of controlled substances;
4. Compliance with applicable state, federal or local laws relating to controlled substances; and
5. Such other conduct which may threaten the public health and safety.
If a DEA registered pharmacy discontinues doing business or transfers ownership to another legal entity, the pharmacy is obligated to notify the nearest DEA Field Office in writing in advance of the termination or transfer. The pharmacy is required to return any unused DEA Form 222s with the word “VOID” written on each one. The notification must indicate where the controlled substances inventory and records will be located after the termination or transfer and how they were transferred or destroyed. Even though the pharmacy may be closing, the pharmacist-in-charge must make arrangements to have the records kept available for inspection up until 2 years after the final controlled substance transaction occurred.
If the pharmacy is being transferred to a different owner, the registered pharmacy is obligated to inform the nearest DEA Field Office of the change at least 14 days prior to the change. The notice must include:
1. The name, address, registration number of the registrant discontinuing business;
2. The name, address, registration number of the registrant acquiring the pharmacy;
3. Whether the business activities will be continued at the location registered by the current business owner or moved to another location. If the latter, give the address of the new location.
4. The date on which the controlled substances will be transferred to the person acquiring the pharmacy.
A complete and final controlled substances inventory must be conducted on the day the pharmacy is terminated or ownership is transferred and, if a transfer is involved, both the seller and the buyer should each keep a copy of the inventory for at least two years from the date the inventory was performed.
Electronic Prescribing and Communications
In June 2000 the Electronic Signatures in Global and National Commerce Act (E-Sign) was adopted into law. While the law is general in nature, it has the potential to have significant impact on the way the practice of pharmacy is conducted. In its most basic form, this law applies to all transactions and permits electronic signatures to have the same validity as traditional ink and paper signatures for purposes of binding agreements. The law specifically bars state and federal agencies from mandating or recognizing only hardcopy signatures. It also indicates that any state or federal law that mandates traditional hardcopy signatures to be preempted. The other part of this law applies to recordkeeping procedures and states that electronic copies of records must be given the same accord as traditional paper-based records.
There is a provision that will permit a federal agency that can prove electronic signatures or records will create a “substantial” hardship can still mandate traditional signatures and records. At the time of writing this text, the DEA had not presented any materials to suggest that electronic signatures or records pertaining to the prescribing or dispensing of controlled substances drugs would cause a substantial hardship.
At the time this manuscript was being prepared, a majority of states have adopted laws implementing electronic signatures and recordkeeping provisions. However, to date, the DEA had not yet authorized electronic prescribing or transmittal of information for controlled substances prescriptions in anything other than traditional hospital-based pharmacy practices. The DEA has had test projects going on for several years. It is expected that the DEA will develop electronic prescribing standards soon and readers are urged to check both state and federal laws on the validity and scope of activities related to electronic communications in pharmacy practice before sitting for the MJPE test.
Classifications of Pharmacies and Special Provisions for Unique Practices
Traditionally, the DEA only recognized two kinds of pharmacies: the typical community “retail” pharmacy and the “institutional” or hospital-based pharmacy. Over time, the DEA started to accept that there are different sets of considerations that need to be made for long-term nursing homes. In DEA language, these institutions are known as “Long Term Care Facilities” (LTCFs). The DEA has not yet recognized pharmacy services to senior citizen independent living situations or assisted living institutions as anything other than community based pharmacy. In one of the more recent developments, the DEA has developed rules for “central fill pharmacies” as described below. There are also some regulations pharmacists should know about using controlled substances in drug addition and rehabilitation clinics.
LTCFs
Nursing homes, retirement care, mental health care, or other facilities or institutions which provide extended health care to resident patients are deemed to be Long Term Care Facilities (LTCFs) by the DEA. Despite the fact that these institutions are not routinely registered with the DEA, they do maintain inventories of controlled substances, usually in the form of medications dispensed by an outside pharmacy directly to the patients but held at nursing stations for administration by LTCF personnel. When patients of these institutions are discharged or expire, or there is a change in the medications of patients, the LTCF may need to dispose of controlled substances it was holding for the patients. The DEA advises operators of these facilities and pharmacists who dispense medications to patients to follow state laws with respect to handling controlled substances no longer needed for a patient or to contact the nearest DEA Field Office for instructions on how to proceed.
There are some exceptions for transmitting Schedule 2 drugs for patients in LTCFs. See the discussion in Prescription Formats and Transmittals, below. The DEA has also issued guidelines for states to use in formulation rules for emergency kits in LTCFs.
Internet Pharmacies
Internet commerce has presented a number of challenges to the DEA because the majority of its experience and requirements deal with traditional community and hospital-based pharmacy practices. The potential for drug diversion and need for new, innovative solutions takes on global proportions. In what will likely be the first of many attempts by the DEA to regulate controlled substance dispensing and distribution with this newer technology, the DEA issued some regulations addressed to pharmacies that pursue internet opportunities.
As with all pharmacies, those that wish to use the internet must be registered with the DEA at the pharmacy’s physical location where controlled substances will be held in inventory if it plans on doing any controlled substances dispensing or distributing. There is no need to register the internet homepage or internet ownership information. The pharmacy must also be licensed by the state in which the pharmacy is physically located and, if required, in those states where it does business. In most cases this means that if the pharmacy located in state X sends prescriptions ordered on the internet to state Y, it would have to have the appropriate licenses from both state X and state Y, in addition to being registered with the DEA. All of the other DEA regulations apply to the internet pharmacy as would apply to any retail pharmacy.
Note that the regulations for delivering drugs, including controlled substances by the United States Postal Services are discussed in the Mailing Prescription Drugs section of this section.
Narcotic Treatment Programs
Congress adopted laws specifically geared for the use of controlled substances in the treatment of addicted patients seeking rehabilitation. The laws deal with two different treatment programs. One is for “maintenance” treatments, usually in Methadone Clinics, and the other is for “detoxification.” Operators of either type of program must register with the DEA using DEA Form 363. The registrant will only be approved to use the narcotics listed on the form in treatment programs. Controlled substances cannot be used for any purpose other than maintenance or detoxification unless the practitioner who operates the program is also registered for “normal” practices associated with controlled substances.
While the DEA has adopted regulations governing these programs, there is also a widely divergent set of regulations adopted by state agencies having jurisdiction over these treatment modalities. Regardless of these differences, Narcotic Treatment Programs must use DEA Form 222 for all transactions involving Schedule 2 drugs; presumably the new electronic CSOS system will replace the need for use of the hardcopy forms once it is implemented. See, http://www.deaecom.gov/csosmain.html.
Methadone
In addition to the use of methadone in narcotic maintenance programs, methadone is used as an analgesic to treat severe forms of pain. This raises concerns when methadone is used to treat pain in an individual who is also a narcotic addict. With one exception, the DEA has taken the position that practitioners who are not registered as operating a narcotic maintenance program cannot prescribe methadone to an addicted patient under the guise of treating pain. The exception occurs when a practitioner who is not part of a narcotic treatment facility prescribes methadone to a narcotic addict experiencing withdrawal while waiting to get into a treatment program. The methadone used in this manner is limited to a maximum three day supply under DEA regulations. There are some states that do not permit this practice.
Narcotics for Patients with Terminal Illnesses or Intractable Pain
The DEA recognizes that the use of narcotics for treatment of patients with intractable pain or pain associated with a terminal illness is effective, appropriate and legitimate. The regulations require that prescriptions for controlled substances be issued for legitimate medical purposes by a practitioner (i.e., an individual authorized under state law to issue a controlled substances prescription) who is acting in the course of medical practice. The DEA has stated that pharmacists should not be concerned when dispensing controlled substances so long as they act with “good faith” when evaluating the legitimacy or appropriateness of a controlled substance prescription. While inappropriate use of narcotics is not acceptable, the DEA does acknowledge that appropriate narcotic drug use will often be accompanied by drug tolerance and physical dependence in individuals who have the need for high doses or prolonged treatment. The DEA has specifically stated that pharmacists receiving prescriptions for high strengths or large quantities of controlled substances for a individual patient should not fear DEA sanctions because “the quantity of drugs prescribed and frequency of prescriptions filled alone are not indicators of fraud or improper prescribing.”
Medical Missions and Humanitarian Charitable Solicitations
In order for practitioners to hand carry controlled substances overseas, while providing charitable medical, dental or veterinary treatment in foreign countries. they must obtain approval from the DEA and the appropriate authority in the foreign country. In these situations, practitioners should allow at least 30 days to obtain the necessary approvals from a local DEA Field office. If a pharmacy is asked to donate controlled substances, the pharmacist should contact the state agency that regulates controlled substances and the DEA Field Office for information on how to proceed.
Central Fill Pharmacies
In recent years the DEA has acknowledged that new technologies and differing market needs have developed so that there are more ways of delivering pharmacy services than the traditional retail and hospital settings. One of these developments has given rise to the concept of a “central fill pharmacy.” The DEA describes a central fill pharmacy as one that “fills prescriptions for controlled substances on behalf of retail pharmacies with which central fill pharmacies have a contractual agreement to provide such services or with which the pharmacies share a common owner”. In this scenario a retail pharmacy receives a prescription from a patient and transmits it to second pharmacy where the prescription medicine is prepared and delivered to the first retail pharmacy for dispensing to the patient.
In this kind of arrangement, records must be maintained by both the central fill pharmacy and the retail pharmacy that completely reflect the disposition of all controlled substance prescriptions dispensed. Central fill pharmacies, in essence, must comply with the same security requirements applicable to retail pharmacies. Note that retail pharmacies that also perform central fill activities may do so without a separate DEA registration, separate inventories, or separate records.
Central fill pharmacies are permitted to prepare both initial and refill prescriptions, subject to all applicable state and federal regulations. Both the central fill pharmacy and the retail pharmacy share responsibility for determining the validity of a controlled substance prescription. The procedures developed by the DEA for central fill pharmacies apply to all controlled substances prescriptions in schedules 2 through 5.
For reasons that are not clear, the DEA does not permit a central fill pharmacy to accept prescriptions from or deliver medications directly to patients by use of the mail. This seems odd given that patients may obtain controlled substance medication from a regular mail order pharmacy. The distinction between a mail order pharmacy and a central fill pharmacy may not make much logical sense but this is the way the DEA has indicated it will treat central fill pharmacies.
There are two ways for a retail pharmacy to submit prescriptions to a central fill pharmacy. The first is to permit faxed prescriptions between the entities. In this situation, the retail pharmacy keeps the original prescription and the central fill pharmacy uses the faxed prescription as its record of dispensing. All records must be retained in a readily retrievable manner. Interestingly, the DEA does allow the prescription information to be transmitted electronically through the internet.
MPJE candidates should check the state laws in the state where licensure is sought to determine if state law permits central fill pharmacies. Many states have been adopting standards that follow the model described by the DEA. Other states have not done so or have unique variations.
Destruction or Transfer of Controlled Substances
When a pharmacy goes out of business, it may transfer its inventory of controlled substances to another pharmacy as described above. It may also transfer the drugs to a DEA registered distributor or back to a DEA registered manufacturer that is also registered by the DEA to destroy controlled substances. This process is known in DEA terms as “reverse distribution.” Records detailing the transfer or destruction must be kept by the pharmacy owner for 2 years after the transfer or destruction, or longer if required by the laws of an individual state.
To transfer Schedule 2 substances, the receiving registrant must issue a DEA Form-222, to the registrant transferring the drugs. This procedure may change with the advent of the paperless Controlled Substances Ordering System (CSOS). MPJE candidates should check the status of the CSOS at the time the examination is taken.
When Schedule 2 through 5 controlled substances are transferred, the transaction must be recorded in writing to show the drug name, dosage form, strength, quantity and date transferred. The document must include the names, addresses and DEA registration numbers of the parties involved in the transfer of the controlled substances.
If the pharmacy going out of business is transferring its controlled substances back to a distributor or manufacturer, the pharmacy must maintain a written record showing:
1. The date of the transaction.
2. The name, strength, form and quantity of the controlled substance.
3. The supplier’s or manufacturer’s name, address, and, if known, registration number.
4. DEA Form-222 will be the official record for the transfer of Schedule 2 substances.
If the transfer is to a reverse distributor registered to dispose of controlled substances, the pharmacy is permitted to forward its controlled substances to DEA-registered reverse distributors who handle the disposal of drugs.
Destruction of Controlled Substances
The DEA asks that any pharmacy having controlled substances it needs to destroy because they have expired, or become adulterated or misbranded to notify the local DEA Field Office for disposal instructions. There is no provision in the law for transferring drugs that should be destroyed between a pharmacy and the DEA. Once each calendar year, a pharmacy may request permission from the DEA to destroy controlled substances using DEA Form 41. All drugs proposed to be destroyed must be listed on the Form together with the proposed date and method of destruction. Written notice to the DEA must also contain the names of at least two witnesses who will observe the destruction. Appropriate witnesses include a licensed physician, pharmacist, mid-level practitioner, nurse, or a state or local law enforcement officer.
Both the DEA Form and the written notice must be received by the nearest DEA Diversion Field Office at least 14 days prior to the proposed destruction date. After reviewing all available information, the DEA Field Office should notify the pharmacy in writing of its decision. Once the controlled substances have been destroyed, signed copies of the DEA Form-41 must be forwarded to DEA. It should be noted that this prior notification procedure need not be followed if an authorized member of a state law enforcement authority or regulatory agency witnesses the destruction. However, DEA Form 41 must still be filled out be the pharmacy and sent to the local DEA Field Office. Although not necessarily covered in the DEA regulations, the DEA suggests that pharmacists contact local environmental authorities prior to implementing the proposed method of destruction to ascertain that hazards are not associated with the destruction.
It should be noted that there is a procedure whereby the DEA will provide a “Blanket Authorization" for Destruction of Controlled Substances” on a very limited basis to registrants who are associated with hospitals, clinics or other registrants having to dispose of used needles, syringes or other injectable objects only. The DEA states that “this limited exception is granted because of the probability that those objects have been contaminated by hazardous bodily fluids.” A pharmacist practicing in these kinds of environments should contact their local DEA Field Office for information about how to request such an authorization. DEA will evaluate requests for a blanket authorization.
If a pharmacy removes controlled substances from the regular inventory because the drugs are damaged, defective, adulterated or misbranded, the drugs must be inventoried and the records maintained with the other controlled substances records. The document must include the following:
1. The inventory date.
2. The drug name.
3. The drug strength.
4. The drug form (e.g., tablet, capsule, etc.).
5. The total quantity or total number of units/volume.
6. The reason why the substance is being maintained.
7. Whether substance is capable of being used in the manufacture of any controlled substance in finished form.
Labeling
Commercial containers (from a manufacturer or distributor) of controlled drugs must bear a label containing a specific symbol indicating the schedule that the drug has been placed in (e.g., C-II or CII). The symbol must be prominent and easily identifiable. There are some exceptions, such as the circumstance that the container is too small to display the symbol or that the container is being used in the course of blinded drug research protocols.
For controlled substances that are dispensed pursuant to a prescription, the prescription label must contain (a) the name and address of the pharmacy (or dispenser); (b) the patient’s name; (c) a prescription serial number; (d) the date that the medication is dispensed; (e) the prescriber’s name; (f) directions for use; and (g) cautionary statements, if any are required by the prescription or other laws. Schedule 2, 3, and 4 prescription labels must also contain the federal transfer warning statement. This statement must include these specific words: Federal law prohibits the transfer of this drug to any person other that the patient for whom it was prescribed. Take specific notice that this transfer warning is not required on a Schedule 5 prescription label. These labeling requirements do not apply to drugs that are dispensed for or to patients who are admitted to a health care facility such as a hospital or nursing home if the drugs are to be administered on site. The DEA regulations do not recognize group homes for the physically or mentally disabled or assisted living homes. In these situations a pharmacist would label prescription drugs dispensed to residents of these facilities as for any other community-based patient.
There are almost as many variations in prescription drug labeling laws for controlled substances at the state level as there are states and territories. Reference must be made to individual state laws to determine what information must appear on the pharmacy label.
Security
Most practitioners are required to store all controlled substances in a “securely locked, substantially constructed cabinet.” The DEA, however, allows some flexibility in how controlled substances are stored in a pharmacy and registered institutions. In these facilities, scheduled drugs may either be stored in an appropriate locked cabinet or be dispersed throughout the stock of non-controlled drugs in a manner calculated to obstruct theft or diversion or a combination of both options may be used. For example, many pharmacies will lock Schedule 2 drugs in a cabinet or drawer and disperse Schedule 3, 4, and 5 drugs throughout the pharmacy inventory. Although not required by the CSA statutes of DEA regulations, the DEA does recommend that pharmacies use a security alarm to deter thefts.
In recognition of the fact that DEA registered pharmacies and other registrants can be the target of thefts, armed robberies, violence and even death, Congress passed the Controlled Substance Registrant Protection Act of 1984 (CSRP). A federal investigation of thefts and robberies is mandated when Controlled substances valued at $500.00 or more are lost, a registrant or other person is killed or suffers significant bodily injury during a robbery or theft of controlled substances or a crime occurs or is planned involving the interstate transport of controlled substances. Breach of this law could result in federal criminal charges and punishment includes fines, imprisonment in a federal penitentiary and the death penalty if a murder occurs during a controlled substances robbery.
Prescriptions
Under the CSA, a prescription is just one of the means of moving a controlled substance drug from the inventory of a practitioner (i.e., a physician or a pharmacy) into the hands of a patient. This is the primary method of authorizing an ultimate user to obtain controlled substances in the community setting. Patients may also receive controlled substances without prescriptions when a drug is administered directly to a patient, when it is dispensed to a nursing unit for administration to a patient in a hospital, or when it is transferred directly from a physician to a patient for later use outside the physician’s presence.
Pharmacists are considered “gatekeepers” when it comes to determining the validity of prescriptions. By authorizing pharmacists to dispense controlled substances only pursuant to legitimate prescriptions, the DEA attempts to minimize the diversion of controlled substances from legal markets into the hands of illegitimate users, sellers, and abusers. Understanding the regulations and duties imposed on pharmacists should help control drug diversion while insuring that legitimate and needy patients have access to necessary and appropriate drug treatments.
Purpose
A prescription for a controlled substance must be issued by a qualified prescriber and for a “legitimate medical purpose.” Under the DEA regulations, an order (also referred to as a “purported prescription”) for a controlled substance may not necessarily be a prescription even if that order is issued by an authorized prescriber. This means that a pharmacist must make a determination as to whether a controlled substance prescription is issued for a valid purpose before medication is dispensed. The appearance of an order, while an important factor, is not determinative of whether or not the order is in fact a prescription. An order might appear to be proper in that it contains all the information necessary to constitute a prescription. It may be issued by an authorized prescriber (see Scope of Practice, below). It may even contain a valid DEA number. But the order is still not valid unless it is issued for a recognized medical use. While the prescriber may have responsibility for prescribing controlled substances for proper purposes, pharmacists also have a “corresponding responsibility” to determine the legitimacy of an order before controlled substances are dispensed.
Validity
There is no single acid test or bright line determinant for assessing the validity of any one prescription. Instead, a list of factors must be considered in making a professional judgment as to whether a controlled substance order should be filled. The DEA suggests that prescribers who write large numbers of controlled substance prescriptions or write for large quantities relative to other prescribers in the area should be suspect. Issuance of prescriptions for antagonistic drugs (depressants and stimulants) at the same time may be another cause for concern. Patterns of patients who appear frequently in the pharmacy with new controlled substance prescriptions or return for refills too soon suggests a problem may be occurring. Patients who present prescriptions in the names of other people or from multiple physicians could be involved in drug diversion. A number of patients appearing in the pharmacy within a short period of time with similar prescriptions from the same prescriber also ought to send up a red flag. A large number of “strangers,” people who have never been patients in the pharmacy before, who show up at the same time with controlled substance prescriptions from the same prescriber may be another factor to consider. A dramatic increase in the controlled substances inventory could be another sign that the pharmacy is being targeted by drug abusers.
Scope of Practice
The only individuals who are authorized to issue controlled substances prescriptions are those who are licensed by a state to prescribe controlled substances and who are either registered with the DEA or exempted from registration. State laws vary considerably on which practitioners are allowed to prescribe controlled substances. Prescribing is also limited by the scope of a practitioner’s license. For example, a state licensed medical doctor may be able to prescribe just about any controlled substance to treat a human disease. A dentist, however, is limited to prescribing controlled substances for treatment of conditions relating to the oral cavity and its supporting structures. Veterinarians are allowed to prescribe controlled substances for animals in most states but a controlled substance prescription from a veterinarian for a human would not be valid. Some states also allow midlevel practitioners to prescribe controlled substances.
Verification
When a pharmacist is presented with a controlled substance prescription or an order that purports to be a prescription the validity of the prescription should be verified. Knowledge of the prescriber and his or her prescribing habits is perhaps the most efficient means of verification. Validation of the prescriber’s DEA registration number is important. A mathematical check should be performed to determine if the number is valid.
Recall that a DEA registration is usually composed of two letters followed by seven digits, the last of which is a “check” number. If the DEA number on a prescription, for example, showed AB1234563, the prescriber’s last name should begin with a “B.” The formula for determining the validly of the check number is to add the first, third and fifth digits and note the last number of that addition. Then add the second, fourth and sixth numbers and multiply that product by two. Take the last number in that calculation and add it to the number saved in the first equation. The last number in the product of this equation should be the same as the seventh digit in the DEA registration number. Using the number in the example above the calculation would look like this:
1 + 3 + 5 = 9;
2 + 4 +6 = 12 x 2 = 24.
Then add 9 + 4 to equal 13.
The last digit, 3, should be the same as the last digit of the registration number. Candidates taking the MPJE are expected to know this equation. In practice, if the math is too cumbersome, there are online sites that will do the math and indicate whether the check digit number is valid. For example see: http://www.msspnexus.com/msspn_dea.asp. There are some variations including how the number is expressed if the first character in a registrant’ name is a number, e.g., 123 Pharmacy Corp. See the pharmacist’s Manual for determining the validity of a registration number in these situations.
Prescription Formats and Transmittals
With the exception of emergency situations, Schedule 2 prescriptions must be in writing and signed by the prescriber. A prescriber may transmit a Schedule 2 prescription to a pharmacy via a facsimile machine (fax) provided that the pharmacist is presented with the original written and signed prescription before the medication is dispensed in normal situations. License applicants and pharmacists should consult state laws to determine whether this provision applies in their particular state. State laws may also dictate that a particular prescription form must be used.
In an emergency situation the pharmacy may receive an oral order or an order transmitted by fax from the prescriber for a Schedule 2 drug but an original written and signed prescription (i.e., a hard-copy backup) must be transmitted to the pharmacy within 7 days of the oral order. Under earlier regulations, the prescriber had to transmit the written prescription to the pharmacy within 72 hours. This extension of time was intended to ease the burden of pharmacists involved with dispensing to long-term care patients or those who receive Schedule 2 drugs for home-hospice care. The backup must contain the statement “Authorization for Emergency Dispensing” and contain the date of the oral order. If the backup is mailed to the pharmacy it must be postmarked within the 7 day period. When received, the pharmacist must attach the backup to the original orally or fax transmitted form and file the documentation with the other Schedule 2 prescriptions. Other provisions allow for fax transmittals of Schedule 2 prescriptions without backup written copies for patients residing in qualified institutions.
The regulations also permit the use of fax transmittals for drugs listed in Schedules 3, 4, and 5. As such, prescriptions for drugs listed in these schedules may now be written, orally transmitted or sent to the pharmacy via a fax machine. Again, state laws should be consulted to determine if there are any restrictions or modifications regarding the transmittal of controlled substance prescriptions.
A controlled substance prescription, if written, must be signed on the date issued; predated and postdated prescriptions are not valid. For Schedule 2 drugs, the prescription must be written in ink, indelible pencil or typewritten and manually signed by the prescriber. Prescriptions may be prepared by a secretary or agent of the prescriber but the prescriber remains responsible for compliance with the legal requirements for issuing the prescription. Pharmacists also have a corresponding responsibility to insure the prescription contains all necessary information and conforms to the legal mandates. Secretaries and agents of a prescriber are permitted to communicate controlled substance prescriptions and refills to a pharmacy but only the authorized prescriber is permitted to actually prescribe.
Refills and Prescription Transfers
Unlike Schedule 2 drugs, which cannot be refilled, Schedule 3, 4, and 5 drugs may be refilled if authorized by the prescriber. Schedule 3 and 4 drugs may be refilled up to a maximum of 5 times within 6 months from the date of issuance. Schedule 5 prescriptions may be refilled as authorized up to the amount allowed under state law (frequently up to one year measured from the date the prescription was issued, not from the date the prescription was first filled). Schedule 2 drugs may be partially filled, giving the effective appearance of a refill, under limited circumstances such as in a long-term care facility or in the rendering of hospice services.
Where refills are permitted, transfers of controlled substance prescriptions between different pharmacies are allowed 1 time only. However, additional transfers between pharmacies that share an electronic real-time database of prescription information are permitted. In other words, there is a distinction between transfers between individually owned pharmacies and those that may share a common ownership such as a chain-store. In this later situation, transfers are allowed up to the maximum number of refills authorized by the prescriber. The information that must be captured in making a transfer of this type is specific and detailed. License applicants and pharmacists should review state law and employer policies before attempting to transfer controlled substance prescriptions.
When a prescription for any controlled substance in Schedule 3, 4 or 5 is refilled, the dispensing pharmacist’s initials, the date the prescription was refilled, and the amount of drug dispensed on the refill must be recorded on the back of the prescription or, if the pharmacy uses computerized records, in accordance with the rules for using computerized records discussed under the Record Keeping section below. If the pharmacist only initials and dates the back of the prescription, it will be assumed that the full amount of the drug called for on the front of the prescription was dispensed on a refill.
Distributions of Controlled Substances
A clear distinction should be made between dispensing activities and controlled substances distributions because the record-keeping requirements are very different. Dispensing is the act of delivering a controlled substance to an ultimate user based on a legitimate prescription order. Distribution, on the other hand, is the delivery of a controlled substance to a person by means other than dispensing or administering. Distribution is the transactional method by which a pharmacy transmits or delivers controlled substances to another pharmacy, a wholesale distributor, or a prescriber or another entity that is registered with the DEA and has the right to possess controlled substances. The DEA has a regulation that permits a pharmacy to distribute up to 5% of its annual dispensed controlled substances before a distributor license will be required.
A prescription cannot be used by prescribers to obtain office supplies of controlled substances for the purpose of dispensing drugs directly to patients. DEA Order Form 222 must be used to distribute Schedule 2 drugs from a pharmacy to a practitioner. An invoice should be used to distribute Schedule 3, 4, and 5 drugs from a pharmacy to a practitioner.
Up until September 2005, when a pharmacy ordered Schedule 2 controlled substances from a manufacturer or wholesale distributor, it had to use the 3 part DEA Order Form 222. Under federal law, the registrant had to sign the form or designate authority to sign it to another responsible individual using a ”power of attorney” This is a legal document that must be signed by the registrant that gives the designated individual the power to sign the form on behalf of the registrant. The document has to be kept on file with the order forms and is subject to inspection by the DEA. Pharmacists should exercise extreme caution in giving someone else the power of attorney to order controlled substances. Because this power can be abused, many state laws place limitations on who may sign the DEA form. The DEA now permits registrants to use the “Paperless Controlled Substances Ordering System (CSOS)” which provides an alternative to using the hardcopy Form 222 to purchase Schedule 2 controlled substances. See, http://www.deaecom.gov/csosmain.html as discussed above in the Study Tips and Narcotic Treatment Programs sections.
Record Keeping
Under the CSA, one of the major responsibilities of pharmacies is to keep accurate and detailed records of activities relating to controlled substances. As with dispensing activities, there is a wide variation between the states in record-keeping mandates that must be followed in addition to the federal requirements.
The DEA requires that all controlled substances records be maintained in the registered pharmacy for a minimum period of two years dating from the last transaction pertinent to a particular record. For example, if a schedule 4 controlled substance prescription is authorized for up to five refills and the patient orders the last refill before the end of the six months since the prescription was issued, the pharmacy would have to maintain the prescription for at least two years after the date of the last refill.
All records dealing with controlled substances must be maintained in “readily retrievable” manner in the pharmacy. This term means controlled substances records kept in some form of computer database storage must be retrievable separate from all other records.
In terms of specific records, the DEA mandates pharmacies maintain the following documents in a readily retrievable fashion:
1. Official Order Forms (DEA Form-222);
2. Power of Attorney authorization to sign Order Forms;
3. Receipts and invoices for Schedule 3, 4 and 5 controlled substances as well as registered chemicals, if any;
4. All inventory records of controlled substances, including the initial and biennial inventories;
5. Records of controlled substances distributed or dispensed (i.e., prescriptions) and threshold amounts of List I chemicals distributed;
6. Report of Theft or Loss (DEA Form-106);
7. Inventory of Drugs Surrendered for Disposal (DEA Form-41);
8. Records of transfers of controlled substances between pharmacies; and
9. DEA registration certificate.
For entities that own 2 or more DEA registered pharmacies, there is a provision for “central recordkeeping.” Shipping and financial records may be stored at a headquarters or offices of the organization if it notifies the nearest DEA Field Office of the intent to do so. Once 14 days have passed after issuing this notice the organization may start keeping these records at the intended location unless the DEA informs the organization that permission to store required records at the intended place is denied.
Computerized Records
A DEA registered pharmacy may use either manual records on hardcopy or computerized records for keeping track of refills for controlled substances prescriptions. It cannot use one method some of the time and the other on different occasions. It must choose one or the other. State law should also be consulted to determine if there are any other requirements for computerized pharmacy data.
Any computer system utilized must provide a mechanism for accessing the original prescription information. At a minimum the original prescription number, date the prescription was issued, the name and home address of the patient, the prescribers name, address and DEA registration number, the name, dosage form, quantity dispensed and strength of the drug dispensed and number of refills authorized, if any, must be available on the computer. The database must also have refill information available. Computerized records must provide for a backup method in case there is a problem with retaining original information in the system.
If the system utilized by the pharmacy permits printouts of the daily controlled substances dispensing activities, a pharmacist must verify the accuracy of the printout information be signing and dating the document. This printout must be available within 72 hours of the date any refills were recorded.
If the system does not permit printouts as described above, the pharmacy must keep a bound record book that a pharmacist must sign and date showing that the refill records were reviewed and are accurate. All systems are required to have the capacity to print refill data that includes the prescribers name, amount dispensed on the refill, the refile dispensing date, identification of the pharmacist (name or initials) and the prescription number, If the entity that owns the pharmacy is permitted to maintain records at a central office such as a headquarters, the refill records must be made available in the pharmacy within 48 hours upon request.
Inventories
Pharmacies are required to maintain a current and complete record of controlled substances inventories and perform an audit of these drugs every 2 years. The required date that the inventory is performed was altered somewhat under the 1997 amendments to the DEA regulations. Now the biennial inventory may be taken anytime within 2 years of the prior inventory. Inventory records for Schedule 2 drugs (and Schedule 1 drugs in the rare event that a pharmacy has any) must be maintained separate and apart from all other records. Schedule 3, 4, and 5 inventory records must also be maintained separate and apart from all other records or maintained in a format that they will be readily retrievable from the ordinary records of the pharmacy. No special form is required for inventory records. However, all records must be written, typewritten, or printed. The name of the drug, its dosage form (i.e., 10-mg capsule), the size of the commercial container (i.e., 100 tablets) and the number of commercial units on hand must be recorded. For open stock containers of Schedule 2 drugs, an exact count of the drugs on hand is required. For open stock of Schedule 3, 4, and 5 drugs, an estimate of the amount on hand is permitted unless the container holds more than 1000 units in which case an exact count is necessary. All inventories, records of purchases, executed order forms (DEA Order Form 222), prescriptions, and distribution records must be kept on file at the pharmacy for a minimum of 2 years.
Prescription Records
Schedule 2 prescriptions must be maintained in a separate file. Similarly, Schedule 3, 4, and 5 prescription records must be maintained separate and apart from all other prescriptions or maintained in a manner that allows them to be readily retrieved from all other prescriptions. There are, however, options available for filing Schedule 3, 4, and 5 prescriptions. If separate prescription files are not kept for prescriptions in these schedules, the prescriptions may be mixed in with the Schedule 2 prescriptions or, mixed in with the non-controlled prescriptions; in either of these options, the Schedule 3, 4, and 5 must be stamped with red ink on the face of the prescription in the lower right hand corner with the letter “C” no less than 1 inch high. Another option is available for pharmacies that utilize automatic data processing (ADP) systems or some other form of electronic record keeping. As in the prior option, Schedule 3, 4, and 5 prescriptions may be mixed in with either the Schedule 2 prescriptions or the non-controlled prescriptions. The red “C” stamp requirement is waived as long as the ADP or other system permits identification of the prescriptions by serial number and retrieval by prescriber name, patient name, drug name, and date dispensed. In addition, records have to be kept of the number of units or volume of scheduled drugs that are dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the pharmacist who dispensed or administered the drug. State laws vary on these procedures and may require other alternatives.
Distribution Records
The kind of information that must be recorded by a pharmacy when it receives controlled substances is complex. For each controlled substance distributed to a pharmacy, a record must be kept of the name of the drug, its finished dosage form (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial), the number of commercial containers acquired from other persons, including the date of and number of units and/or commercial containers in each acquisition to inventory and the name, address, and registration number of the person from whom the units were acquired. If a pharmacy distributes (as opposed to dispenses) controlled substances to other registrants, the number of commercial containers distributed, including the date of and number of containers in each reduction from inventory, and the name, address, and registration number of the person to whom the containers were distributed must be recorded. The pharmacy must also record the number of units of finished forms and/or commercial containers distributed or disposed of in any other manner, such as destruction, including the date and manner of distribution or disposal, the name, address, and, if applicable, the registration number of the person to whom distributed, and the quantity in finished form distributed or disposed.
Location of Records
Prescriptions, completed inventories, and executed order forms (DEA Order Form 222) must be kept in the pharmacy where the prescription was originally filled for at least 2 years from the date the drugs were last dispensed. All controlled substance prescriptions and records maintained in the pharmacy are subject to inspection by DEA officers. Pharmacies may keep financial and shipping records, such as invoices and packing slips, at a central location like a chain store headquarters. Special permission to store the other records at a central location may be available in limited circumstances.
Employment Disqualifications and Requests for Waivers
The DEA prohibits pharmacies with controlled substances available from employing anyone with access to those controlled substances who has been convicted of a felony relating to controlled substances, or who, at any time, has had an application for DEA registration denied, revoked, or surrendered “for cause.” This term is defined to mean “surrendering a registration in lieu of, or as a consequence of, any federal or state administrative, civil or criminal action resulting from an investigation of the individual’s handling of controlled substances.” While there is a procedure that permits pharmacies to apply for a waiver of this provision, permission is rarely granted.
Reporting Controlled Substance Theft or Loss
Upon discovery of a significant loss or theft of controlled substances a DEA registered pharmacy must immediately notify the local DEA Field Office and the local police authority by telephone, facsimile or by a brief written message explaining the circumstances. There is no bright line test of how “significant” the loss or theft must be. Pharmacists should judge the situation in the context of the amount of theft or loss as compared to the general controlled substances inventory. Missing six or seven phenobarbital pills is not significant. Loss of a whole unopened bottle of 500 Valium tablets is definitely significant. The DEA asks pharmacists to err on the side of caution and report losses when not sure of whether or not the loss should be considered significant. Some factors to consider suggested by the DEA for determining significant loss include:
1. The schedule of the missing items.
2. The abuse potential of the missing items.
3. The abuse potential in your area of the missing substance.
4. The quantity missing (one tablet vs. one bottle or container).
5. Is this the first time this loss has occurred? Has a similar loss occurred before?
6. Was this loss reported to local law enforcement authorities?
In addition to the immediate notification requirement, a pharmacy must also complete DEA Form 106 and send it to the local DEA Field Office. Most states also require pharmacies to send a copy of this form to the state Board of Pharmacy or the agency that oversees pharmacy licensure. In any event, the pharmacy must also keep a copy of the Form 106 with its own controlled substances records for use if a controlled substances audit is performed. The Form 106 must also be made available for inspection upon request. Information on this form is to include the circumstances of the loss and theft and the quantity and names of the controlled substances involved. At a minimum the DEA Form 106 must include:
1. Name and address of the pharmacy
2. DEA registration number
3. Date of theft (or date that the theft was discovered).
4. Name and telephone number of local police department notified
5. Type of theft (night break in, armed robbery, etc.)
6. Listing of symbols or cost code used by pharmacy in marking containers (if any)
7. Listing of controlled substances missing from theft or significant loss
If a pharmacy reports a theft or loss of controlled substances to the DEA and later discovers after an investigation that no loss or theft actually occurred (e.g., the missing bottle of 500 Valium tablets was found to have been accidentally thrown out and recovered from the trash), the DEA does not require that the reporting form be filed. However, the DEA should be given written notice of the circumstances as to why the pharmacy is not completing Form 106. The state agency and local police should also be informed.
Breakage/Spillage
The DEA does not consider that incidental breakage, damaged goods received in transit or spillage of controlled substances as a “loss” that must be reported. When these kinds of incidents occur, the method discussed above for reverse transfer or destruction of controlled substance should be followed. Note the action taken in the controlled substances records in case an audit is performed. DEA Form 41 should be used to make a record of the circumstances involved.
Penalties
Penalties for violation of the CSA and DEA regulations may be very severe. Many provisions require intent to violate or knowledge of an infraction of the CSA. There are other provisions, however, including many of the record-keeping mandates applied to pharmacists that impose a strict liability type of penalty where knowledge or intent are not considered. Both civil fines and criminal sanctions are possible. In addition, states may also impose penalties for controlled substance violations. Revocation of the federal registration and suspension or revocation of any state issued controlled substance licenses or registrations may also be administratively imposed. Penalties are not exclusive to any one jurisdictional body. In other words, the same act of wrongdoing could result in federal civil and/or criminal penalties, and state criminal and/or civil penalties and administrative sanctions against federal and state registrations and licenses. Put still another way, the prohibitions against double jeopardy in the United States Constitution do not apply to health care licensees who violate the multiple requirements of controlled substances laws. This means that one offending activity may result in multiple penalties. Therefore, it is in the best interest of pharmacists to know and follow the controlled substances laws.
Intentional or Knowledgeable Penalties
Pharmacists who knowingly dispense controlled substances based on orders that are not valid are subject to significant penalties. Imprisonment of up to four years and fines as high as $30,000 may be imposed for each violation. The knowledge requirement may be implied by the circumstances. Deliberate ignorance of objectively determined facts that should indicate that a prescription has been forged, altered, or issued for a non-legitimate medical purpose will expose the dispensing pharmacist to criminal penalties. In other words, the “ostrich defense,” i.e., figuratively sticking one’s head in the sand to ignore objectively verifiable facts, does not work in the pharmacist’ favor. Studied avoidance of realities and circumstances may be used as evidence to create an inference that the pharmacist knew or should have known that a purported prescription was not legitimate.
Record-Keeping Penalties
The penalties for failure to keep records as mandated by the CSA and DEA regulations include monetary fines, loss of registration and criminal sanctions. A pharmacy that is charged with a record-keeping violation may be subject to a civil penalty of $25,000 for each violation. Imprisonment is also possible for intentional record-keeping violations. However, for civil charges to apply, no knowledge or intent is needed. In other words, pharmacists and pharmacies are strictly liable for record-keeping violations. Innocent errors, mistakes, and negligent inadvertence to details could still lead to significant penalties under the applicable laws.
Applicants should be aware of all state laws in their jurisdictions that may modify the rules discussed above. Also see the State Pharmacy Practice Laws section below.
Mailing Prescription Drugs
Mailing Drugs
EDITOR: NOTE TITLE CHANGE PLEASE
Ever since 1994, pharmacists may send nearly all OTC and prescription-only drugs to patients using the United States Postal Service (USPS), an agency of the federal government. The postal regulations still prohibit the mailing of abortive drugs or devices and the unsolicited mailing of contraceptives. About the only other special alert pharmacists should be aware of is that postal service bans mailing of powders that might be able to escape from their containers; however, if the powder is packed in leak-proof receptacles or sealed in durable, leak-proof outer containers they can be mailed. There are also provisions for shipping chemicals but they do not apply to pharmaceutical products.
The DEA’s Pharmacist’s Manual contains pertinent information about the mailing of controlled substances. Basically these are the same as those for non-controlled substances. The USPS regulations permit mailing any controlled substances, provided that they are not “outwardly dangerous or of their own force could cause injury to a person’s life or health.” In addition, the pharmacy packaging of the controlled substance must be properly labeled with all of the information the DEA mandates for dispensed medications including the name and address of the pharmacy. The visible outer wrapper should be securely wrapped in plain paper and should not have any indication as to the contents of the package.
Pharmacists are prohibited from shipping or delivering controlled substances dispensed pursuant to a valid prescription to a different country without authorization. This activity is deemed by the FDA to be drug exporting and is not permitted unless the pharmacy has a DEA exporter registration.
Private carriers like United Parcel Service (UPS), and DHL Worldwide Express have their own rules and regulations about the products they will accept for delivery. The policies of private carriers are beyond the scope of this review.
State Pharmacy Practice Laws
Every state has legislation that regulates the profession of pharmacy. Even so, there is a great deal of variation in state laws pertaining to pharmacy practice. The laws of each state for which licensure candidates will be taking the pharmacy law exam should be reviewed individually. There are some general issues addressed by nearly all states. The NABP Survey of Pharmacy Law provides lists of the common issues and how they are addressed in each state. Some of the items that should be reviewed include:
1. The minimum education, training, and experiential qualifications which license applicants must satisfy at the time of examination or registration.
2. The authority, makeup, and duties of the agency, usually known as the State Board of Pharmacy, charged with enforcement and administration of the pharmacy laws.
3. How licenses or other permits to engage in the practice of pharmacy are granted and renewed and for what period of time.
4. The conditions under which licenses or registrations to engage in the practice of pharmacy may be restricted, canceled, or revoked.
5. The activities included in the scope of pharmacy practice and what duties might be delegated to non-pharmacists.
6. The individual who is responsible for compliance with state and federal pharmacy laws.
7. Whether continuing education is necessary for maintaining a pharmacist license and what those requirements include.
8. What kinds of labels, labeling, and record keeping are required for controlled and non-controlled prescription drugs dispensed in a pharmacy.
9. Whether there are any special rules that distinguish how pharmacy is practiced in community (retail) settings vs. an institutional (hospital) setting.
10. Whether the state participates in “reciprocal” registration with other states and, if so, what conditions have to be satisfied before reciprocating..
11. Who is qualified to prescribe drugs and the conditions that must be met before a prescription is dispensed.
12. Whether the state has any laws regarding drug product selection, generic substitution, therapeutic substitution, or formularies.
13. Whether licensure, registration or certification is required for pharmacy technicians and/or educational requirements for personnel who assist a pharmacist.
There are, of course, numerous other issues such as nuclear pharmacy regulations, prescription drug compounding, and third-party benefits laws that are too long and complex for a law review of this type. The above list is only a suggestion to help license applicants get started on studying for a pharmacy law examination.
On a broad scale, one of the more common issues confronted under state laws deals with the scope of pharmacy practice. Activities that are normally associated with the practice of pharmacy include evaluation and interpretation of a prescription, selecting a drug product to be dispensed pursuant to a prescription, preparation of the patient label and performing a drug utilization review to determine that a prescription medication is necessary and appropriate for a patient. Patient counseling on the proper use and storage of medications is usually included in the scope of pharmacy. In contrast, pharmacists rarely are assigned duties to make physical assessments of patients while engaging in the practice of pharmacy. Most state laws also make provisions for assigning responsibility for compliance with state and federal pharmacy laws to a pharmacist-in-charge or a pharmacist on duty. In addition, a corporate officer or other designated corporate employee may be designated as one of the responsible parties when the pharmacy is owned and operated as a corporation.
Federal Law Review : Questions
Question #1
Under which of the following circumstances may a drug manufacturer’s representative legally distribute a federal legend drug sample?
Choices:
A: When requested by a community pharmacist.
B: When requested by a hospital pharmacist.
C: When requested in writing by a prescriber.
D: All the time.
E: When requested by an community-based mental health pharmacist.
Correct Answer: C
Explanation:
Under the PDMA, federal legend drug samples may be distributed by manufacturer’s representatives only when a prescriber requests the samples in writing. Community pharmacies are not allowed to have any samples of federal legend drugs. Hospital pharmacies are allowed to possess samples but only when they are requested to do so by a prescriber.
Competency Statement: (1.02)
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Question #2
A DEA registration is NOT required for an individual who is legally recognized as a prescriber and is a:
Choices:
A: doctor of medicine practicing as a family physician.
B: physician’s assistant working in a hospital.
C: medical resident employed by a teaching and research hospital.
D: doctor of osteopathic medicine and surgery specializing in psychiatry.
E: nurse clinician (nurse-practitioner).
Correct Answer: C
Explanation:
All of the listed individuals must obtain a DEA registration number to prescribe controlled substances except a medical resident who is employed by a teaching or research hospital. The resident uses the hospital’s DEA registration number when prescribing controlled substances.
Competency Statement: (1.04)
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Question #3
The pharmacist who is charged with responsibility for compliance with state and federal pharmacy laws is most often designated as the:
Choices:
A: chief operating officer.
B: pharmacist-in-charge.
C: pharmacy manager.
D: responsible pharmacist.
E: Pharmacy District Manager.
Correct Answer: B
Explanation:
The term "pharmacist-in-charge" is used most frequently to indicate which individual pharmacist can be held legally responsible for complying with the applicable laws. A few states do not use this term and, instead, elect to hold any "pharmacist on duty" responsible for legal compliance. The other terms are usually used in conjunction with employment status.
Competency Statement: (1.01)
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Question #4
Which of the following activities is NOT usually associated with the practice of pharmacy?
Choices:
A: Selecting a specific drug product to be dispensed pursuant to a prescription.
B: Monitoring a patient’s drug therapy and use.
C: Making a physical assessment of the patient.
D: Counseling a patient on the safe use and storage of prescription medications.
E: Interpreting and evaluating a prescription.
Correct Answer: C
Explanation:
Drug product interchange (generic selection or generic substitution), monitoring drug therapy, counseling patients, and interpreting prescriptions are all activities associated with core pharmacy practice. Making a physical assessment of a patient for the purpose of diagnosis is considered the practice of medicine and is generally outside the legal scope of pharmacy practice in the vast majority of practice settings.
Competency Statement: (2.02)
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Question #5
Which of the following institutions or individuals is NOT ordinarily required to obtain a registration from the DEA before handling controlled substances?
Choices:
A: A hospital
B: A staff physician performing research with controlled substances at a medical teaching hospital
C: A community pharmacy owned by a chain store corporation
D: A pharmacist employed by a hospital or community pharmacy
E: A nursing home
Correct Answer: D
Explanation:
With the exception of a pharmacist who owns a pharmacy solely in his or her own name (a "sole practitioner"), pharmacists do not register with the DEA as a predicate to handling or dispensing controlled substances. Most, but not all, states issue a separate controlled substances license to pharmacists and other practitioners who handle these drugs. Physicians, hospitals, pharmacies, and nursing homes that dispense or otherwise handle controlled substances do need to obtain a DEA registration.
Competency Statement: (1.04)
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Question #6
Assume that a podiatrist asks a community pharmacist to sell a 1-month supply of a prescription-only oral contraceptive for his wife, who also happens to be his office manager, using the podiatrist’s prescription. Which of the following responses by the pharmacist are lawful?
Choices:
A: Have the podiatrist write a prescription and dispense it as ordered.
B: Decline the request because it is beyond the scope of practice of the podiatrist to prescribe oral contraceptives.
C: Sell the oral contraceptives to the podiatrist as an office supply, using a pharmacy invoice to record the transaction.
D: Sell the podiatrist a 2- or 3-day supply as a professional courtesy and tell him that this is a one-time favor.
E: Dispense the oral contraceptive as written and make a call to the state podiatry board.
Correct Answer: B
Explanation:
The issue of who is allowed to prescribe which drugs is determined by state law. Most state laws make these determinations by defining the scope of practice of the practitioner. In the vast majority of cases podiatry is limited to the treatment of feet and nails (including fingernails). Prescribing contraceptive drugs is outside the scope of the practice of podiatry.
Competency Statement: (1.04)
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Question #7
Which of the following statements regarding patient counseling about drugs is TRUE?
Choices:
A: All state laws require a pharmacist to counsel patients on all prescription drugs including refills.
B: Any individual designated to work in a pharmacy department may provide counseling about prescription drug use.
C: A pharmacist may counsel any patient about the use of OTC and prescription-only drugs at any time the pharmacist believes counseling is necessary and appropriate.
D: Licensed pharmacy interns may counsel patients about prescription drug use without the supervision or presence of a pharmacist.
E: Pharmacies employing the United States Postal Service to provide prescription drugs are exempt from all counseling requirements as long as written information about the drug is provided.
Correct Answer: C
Explanation:
Originally, OBRA-90 mandated that state law require pharmacists or their agents to offer to counsel in certain situations. That counseling requirement has been expanded to include new prescriptions for all patients. The laws are specific that while others may make the offer</EM> to counsel, only a pharmacist (or perhaps a pharmacist intern under the supervision of a pharmacist) may actually provides the counseling. Under the concept of professional discretion or judgment, a pharmacist may advise any patient at any time about the use of OTC and prescription-only medication.
Competency Statement: (1.05)
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Question #8
Pharmacies are licensed or registered to engage in the practice of pharmacy by which one of the following administrative agencies?
Choices:
A: Centers for Medicare & Medicaid Services (CMS)
B: The Joint Commission on Accreditation of Healthcare Organizations TM (JCAHO R )
C: Department of Health and Human Services (DHHS)
D: The State Board of Pharmacy or its equivalent and the Drug Enforcement Administration (DEA)
E: The Food and Drug Administration (FDA)
Correct Answer: D
Explanation:
CMS administers Medicare and Medicaid programs. JCAHO only certifies institutions as complying with its standards of practice. DHHS is the federal administrative agency that oversees the FDA. The FDA does not license or register pharmacies even though, to a limited extent, it does have regulatory authority over some pharmacy activities. The states, through the Board of Pharmacy or an equivalent body, actually grant a pharmacy authority to operate and the DEA registers pharmacies to handle and dispense controlled substances.
Competency Statement: (2.02)
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Question #9
If a drug is placed in a schedule that is regulated by the Drug Enforcement Administration, that drug is classified as a:
Choices:
A: Controlled Substance.
B: Federal Legend.
C: Sample.
D: Generic.
E: Investigational New Drug (
Correct Answer: A
Explanation:
Controlled substances are placed into one of five schedules by the DEA. Federal legend drugs are those designated by the FDA as available only on the prescription of a licensed prescriber. INDs are drugs authorized for research uses by the FDA. A sample drug is one designated by a manufacturer or wholesaler as available for distribution without charge. A generic drug is one that is made by more than one manufacturer.
Competency Statement: (3.02)
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Question #10
On June 1, 2007 a medical doctor legitimately issues a prescription for #35 Darvon, a prescription-only C-IV controlled substance to a patient with directions to take one dose every 4-6 hours as needed for migraine. The prescription indicates that it may be refilled six (6) times. The patient has the prescription filled at First Community Pharmacy on June 1, 2007. The patient returns to that pharmacy on July 1, 2007 and obtains a refill. On August 1, 2007 the patient goes to ABC Retail Pharmacy, an independent pharmacy not affiliated in any way with First Community Pharmacy, and asks that the prescription be transferred and refilled. The prescription is filled and dispensed at ABC Retail Pharmacy on August 1, 2007. The patient returns to ABC pharmacy on September 1, 2007, again on October 1, 2007 and again on November 1, 2007 and obtains refills of the prescription on each day.
Under federal law, how long must First Community Pharmacy maintain the prescription in its records?
Choices:
A: Until at least June 30, 2009
B: Until at least June 30, 2008
C: Until at least November 1, 2009
D: Until at least November 1, 2008
E: Until the pharmacy is either closed or transferred to a new owner
Correct Answer: A
Explanation:
Federal law requires pharmacies to keep controlled substances prescriptions at least 2 years after the date most recently dispensed. Having dispensed a refill on July 1, 2007, First Community must keep it on file until at least June 30, 2009.
Competency Statement: (3.01)
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Question #11
On June 1, 2007, a medical doctor legitimately issues a prescription for #35 Darvon, a prescription-only C-IV controlled substance to a patient with directions to take one dose every 4-6 hours as needed for migraine. The prescription indicates that it may be refilled six (6) times. The patient has the prescription filled at First Community Pharmacy on June 1, 2007. The patient returns to that pharmacy on July 1, 2007 and obtains a refill. On August 1, 2007, the patient goes to ABC Retail Pharmacy, an independent pharmacy not affiliated in any way with First Community Pharmacy, and asks that the prescription be transferred and refilled. The prescription is filled and dispensed at ABC Retail Pharmacy on August 1, 2007. The patient returns to ABC pharmacy on September 1, 2007, again on October 1, 2007, and again on November 1, 2007, and obtains refills of the prescription on each day.
Under federal law, how long is ABC Retail Pharmacy required to maintain the prescription in its records?
Choices:
A: Until at least October 31, 2009.
B: Until at least May 31, 2009.
C: Until at least October 31, 2009.
D: Until at least December 31, 2009.
E: Until the pharmacy is either closed or transferred to a new owner.
Correct Answer: C
Explanation:
Using the same rule explained in the previous question, because ABC last dispensed the controlled substance on November 1, 2007, it must keep the prescription on file until at least October 31, 2009.
Competency Statement: (3.01)
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Question #12
On June 1, 2007, a medical doctor legitimately issues a prescription for #35 Darvon, a prescription-only C-IV controlled substance to a patient with directions to take one dose every 4-6 hours as needed for migraine. The prescription indicates that it may be refilled six (6) times. The patient has the prescription filled at First Community Pharmacy on June 1, 2007. The patient returns to that pharmacy on July 1, 2007 and obtains a refill. On August 1, 2007, the patient goes to ABC Retail Pharmacy, an independent pharmacy not affiliated in any way with First Community Pharmacy, and asks that the prescription be transferred and refilled. The prescription is filled and dispensed at ABC Retail Pharmacy on August 1, 2007. The patient returns to ABC pharmacy on September 1, 2007, again on October 1, 2007, and again on November 1, 2007, and obtains refills of the prescription on each day.
In addition to the above facts the patient returns to ABC Retail Pharmacy on December 2, 2007, and asks for another refill. What is the pharmacist legally required to do?
Choices:
A: Dispense the refill because the prescription is still valid.
B: Refuse to dispense the refill because the legal limit on the number of refills allowed would be exceeded.
C: Transfer the prescription back to First Community Pharmacy so that the patient may obtain the remaining refill called for in the original prescription.
D: Inform the local DEA office that the patient is attempting to obtain controlled substances on an illegally issued prescription.
E: Give the prescription order to the patient and ask that additional refills be obtained from a different pharmacy.
Correct Answer: B
Explanation:
Federal law limits refills on Schedule 3 and 4 drugs to five times within a 6-month period from the date the prescription is issued. This five refill limit applies even though a physician indicates, as in this case, that more than five refills are authorized. Here, because the patient has already obtained five refills, the pharmacy must refuse to dispense any additional medication. Likewise, no other pharmacy could dispense any other refills on the authority of this prescription. In any event the prescription could not be transferred back to the original pharmacy or any other pharmacy because DEA regulations limit the transfer of controlled substances prescriptions to one time only between unrelated pharmacies. Although not listed as a possible answer, the pharmacist could call the physician to obtain a new prescription authorization.
Competency Statement: (3.02)
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Question #13
A hospital-based pharmacy is legally permitted to provide a limited quantity of controlled substances medications that are not under the control of a pharmacist to:
Choices:
A: an emergency-room supply cabinet that is secured under a protocol approved by the pharmacy director.
B: an unsecured cabinet in a nursing station.
C: a stockroom in the hospital basement.
D: an automobile owned and operated by the hospital for transferring patients between the hospital and off-site clinics.
E: a supply cabinet located just outside the pharmacy.
Correct Answer: A
Explanation:
DEA regulations allow a hospital pharmacy to supply a limited number of doses of controlled substances drugs to the emergency room if the drugs are stored in a locked cabinet. Procedures must be established under an approved protocol for stocking, restocking, and logging out all drugs stored in the cabinet. The pharmacy director must approve the protocol.
Competency Statement: (2.03)
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Question #14
In most states, the Board of Pharmacy or equivalent administrative agency issues controlled substances licenses to:
Choices:
A: pharmacies.
B: pharmacists.
C: physicians.
D: authorized prescribers.
E: all of the above.
Correct Answer: E
Explanation:
Most states issue controlled substances licenses, in addition to other kinds of licenses, to pharmacists, pharmacies, physicians, and other authorized prescribers. The Board of Pharmacy or an equivalent agency usually issues the licenses.
Competency Statement: (3.02)
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Question #15
Which federal agency determines whether drugs are safe and effective for intended uses?
Choices:
A: FDA
B: DEA
C: DHHS
D: CMS
E: BNDD
Correct Answer: A
Explanation:
The FDA makes the determination that drugs are safe and effective for intended purposes when it approves an NDA for an individual drug. The DEA determines if FDA approved drugs should be controlled and how they should be scheduled. DHHS is the parent agency of the FDA but does not make determinations about drugs directly. CMS administers Medicare and Medicaid and, at least in part, pays suppliers for those drugs used by beneficiaries of those programs. The BNDD is the predecessor to the DEA and no longer exists.
Competency Statement: (3.01)
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Question #16
Which federal agency determines whether drugs should be designated as controlled substances?
Choices:
A: FDA
B: DEA
C: DHHS
D: CMS
E: BNDD
Correct Answer: B
Explanation:
As explained in the answer to question 15, the DEA determines which drugs should be designated as controlled substances.
Competency Statement: (3.01)
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Question #17
Which governmental agencies have authority to regulate controlled substances?
Choices:
A: The federal government exclusively
B: State governments exclusively
C: The World Trade Federation
D: State and federal governments concurrently
E: Local municipalities only
Correct Answer: D
Explanation:
Both the federal and individual state governments have authority to regulate controlled substances. The World Trade Federation is not a government agency. Local municipalities usually do not have direct authority to regulate controlled substances.
Competency Statement: (3.01)
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Question #18
Who determines which schedule a drug designated as a controlled substance will be placed in?
Choices:
A: The President of the
B: The FDA Commissioner
C: The
D: The Secretary of Health and Human Services
E: The Speaker of the House of Representatives
Correct Answer: C
Explanation:
Authority to designate which schedule a controlled substance will be placed in is vested in the United States Attorney General under federal statute. This cabinet-level presidential appointee is in charge of the Department of Justice, which is the parent agency of the DEA.
Competency Statement: (3.02)
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Question #19
Who is required to register with the DEA?
Choices:
A: All pharmacies that dispense controlled substances
B: All pharmacists who dispense controlled substances
C: All licensed pharmacy interns while working in a pharmacy that dispenses controlled substances
D: All employees of drug manufacturers that produce controlled substances
E: All police officers who might encounter controlled substances while on duty
Correct Answer: A
Explanation:
Pharmacists and pharmacy interns are not required to register with the DEA before handling controlled substances. Neither police officers nor employees of manufacturers of controlled substances are required to obtain DEA registration. Pharmacies, however, must register with the DEA if controlled substances are handled.
Competency Statement: (2.02)
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Question #20
Which of the following categories of drugs must be labeled with the federal transfer warning when dispended from a community pharmacy?
I. Schedule 2 controlled substances
II. Schedule 3 and 4 controlled substances
III. Schedule 5 controlled substances
Choices:
A: I only
B: III only
C: I and II only
D: II and III only
E: I, II, and III
Correct Answer: C
Explanation:
The federal "transfer warning," ("Federal law prohibits the transfer of this drug to any person other that the patient for whom it was prescribed"), must appear on the pharmacy label of dispensed controlled substances listed in Schedules II, III, and IV. The warning is not required for Schedule V controlled substances.
Competency Statement: (1.04)
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Question #21
How are controlled substances to be stocked in a pharmacy?
Choices:
A: In a locked cabinet in the pharmacy
B: Dispersed throughout the inventory of non-controlled drugs in the pharmacy
C: In a separate storage room away from the pharmacy
D: In a safe that is accessible only by the pharmacist-in-charge
E: Either choice A and B or a combination of both.
Correct Answer: E
Explanation:
DEA regulations allow pharmacies to either stock controlled substances in a locked cabinet in the pharmacy or disperse these medications throughout the other drug inventory. A combination of both methods is also permissible. For example, many pharmacies lock up Schedule 2 controlled substances while dispersing Schedule 3, 4, and 5 drugs with the rest of the pharmacy inventory.
Competency Statement: (2.03)
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Question #22
What is a "purported prescription"?
Choices:
A: An order for a controlled substance that has not been issued for a legitimate medical purpose.
B: An order for a controlled substance from a prescriber that has not yet been verified by a pharmacist.
C: A legitimately prescribed controlled substance order that was communicated to a pharmacist by the prescriber’s agent.
D: A legitimately prescribed controlled substance order issued by a midlevel practitioner.
E: An order for a controlled substance issued by a prescriber whose practice is located in a state other than where the pharmacy is located.
Correct Answer: A
Explanation:
The term "purported prescription" is used in DEA regulation 21 CFR 1306.04 to describe an order for a controlled substance that may originate from a physician and appear to be a prescription in all other regards but is not deemed to be a prescription because it was issued for a non-legitimate reason. For example, a prescription that is sold to a patient by a physician outside of a normal patient-physician relationship for purposes of diversion, is a purported prescription. Note that even though a pharmacist might verify that an authorized prescriber issued a prescription, it is no less an unlawful purported prescription if issued for a reason that is not a legitimate medical purpose.
Competency Statement: (1.04)
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Question #23
How many times may a Schedule 5 drug be refilled according to federal law?
Choices:
A: Five times in a 6-month period
B: Twelve times in a 12-month period
C: For a maximum of 2 years
D: As authorized by the prescriber
E: Schedule 5 drugs cannot be refilled
Correct Answer: D
Explanation:
Unlike the limits on refills of Schedule 3 and 4 controlled substances (five times in 6 months), Schedule 5 prescriptions may be refilled as many times as authorized by the prescriber or allowed by state law (usually 1 year from the date of issuance).
Competency Statement: (1.04)
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Question #24
Under federal law, how many times may a prescription for a refillable controlled substance be transferred between different (unrelated) pharmacies?
Choices:
A: As often as the patient and the prescriber agree
B: A maximum of 3 times
C: A maximum of 2 times
D: One time only
E: Never
Correct Answer: D
Explanation:
Federal law limits the transfer of controlled substance prescriptions to one time between unrelated pharmacies. For purposes of this rule, "unrelated" means not under common ownership. For example, an independently owned pharmacy and a chainstore pharmacy corporation are unrelated.
Competency Statement: (1.06)
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Question #25
Under federal law, how many times may a prescription for a refillable controlled substance be transferred between commonly owned pharmacies that share an electronic real-time database of prescription files?
Choices:
A: As often as the patient and the prescriber agree
B: A maximum of 3 times
C: One time only
D: As many times as the prescription is legally refillable
E: Never
Correct Answer: D
Explanation:
Two chain-store pharmacies owned by the same corporation are related and may transfer controlled substances prescriptions as often as refills are authorized but only if the two pharmacies are linked by a real-time online network. Chain pharmacies, even though owned by one corporation, are limited to the one-time transfer rule if they are not linked by a real-time online computer network.
Competency Statement: (1.04)
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Question #26
According to federal law how does a prescriber obtain a supply of Schedule 2 controlled substance drugs from a pharmacy for use in the prescriber’s office?
Choices:
A: The supply is obtained by using one of the prescriber’s prescriptions marked "For Office Use" in the space designated for a patient’s name.
B: The supply is obtained by using a DEA Form 222.
C: The supply is obtained by using a DEA Form 106.
D: The supply is obtained by having the pharmacist record the transaction on a pharmacy invoice that is kept with the other Schedule 2 controlled substances records.
E: This practice is not permitted. The prescriber must obtain the drugs from a wholesale distributor of the manufacturer.
Correct Answer: B
Explanation:
Schedule 2 controlled substances may be distributed (i.e., transferred) between DEA registrants only by use of DEA Form 222. Schedule 2 drugs cannot be dispensed by a pharmacy to a prescriber by use of a prescription that indicates the drugs will be used for the prescriber’s office. Form 106 is used to report stolen or missing controlled substances.
Competency Statement: (1.06)
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Question #27
According to federal law, how does a prescriber obtain a supply of Schedule 3 or 4 controlled substance drugs from a pharmacy for use in the prescriber’s office?
Choices:
A: The supply is obtained by using one of the prescriber’s prescriptions marked "For Office Use" in the space designated for a patient’s name and the document is filed in the pharmacy with its schedule 3 and 4 controlled substances prescriptions.
B: The supply is obtained by using a DEA Form 222 or the online CSOS.
C: The supply is obtained by using a DEA Form 106.
D: The supply is obtained by having the pharmacist record the transaction on a pharmacy invoice that is kept with the other Schedule 3 and 4 controlled substances records.
E: This practice is not permitted. The prescriber must obtain the drugs from a wholesale distributor of the manufacturer.
Correct Answer: D
Explanation:
In contrast to the procedure for transferring Schedule 2 controlled substances between DEA registrants, Schedule 3 and 4 drugs are to be distributed using an invoice that is to be filed with other Schedule 3 and 4 records.
Competency Statement: (1.02)
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Question #28
How often does federal law require a pharmacy to perform a controlled substance inventory?
Choices:
A: Monthly
B: Once every year
C: Every 2 years
D: Every 3 years
E: Every 4 years
Correct Answer: C
Explanation:
Federal law requires pharmacies to complete a controlled substance inventory every 2 years. Note that many states require inventories to be taken more frequently. A 1-year period is common.
Competency Statement: (1.07)
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Question #29
According to federal law, how long does a pharmacy have to keep prescriptions, invoices, and inventory records for Schedule 2 drugs?
Choices:
A: One year
B: Two years
C: Three years
D: Five years
E: Until the pharmacy is closed or transferred to a new owner
Correct Answer: B
Explanation:
Federal law requires pharmacies to maintain records of controlled substances prescriptions, invoices, and transfer records as well as inventories for at least 2 years. Note that many states have requirements that at least some of these records be kept for a longer period. For example, some states require that all prescriptions be kept a minimum of 5 years.
Competency Statement: (1.07)
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Question #30
If the DEA believes that a pharmacy has knowingly violated the controlled substances laws, it may proceed against the pharmacy by:
Choices:
A: Seeking criminal penalties
B: Seeking civil penalties
C: Seeking to have the pharmacy’s DEA registration revoked
D: Seeking to have the pharmacy’s DEA registration suspended
E: Seeking any and all of the above sanctions
Correct Answer: E
Explanation:
Penalties for willful or knowing violations of the controlled substances laws may include criminal and civil sanctions as well as administrative actions against the pharmacy’s DEA registration. Therefore, all of the answers are correct.
Competency Statement: (3.02)