THE APhA COMPLETE REVIEW FOR PHARMACY, 7th Ed

2. Federal Pharmacy Law - Walter L. Fitzgerald, Jr, BPharm, MS, JD

Introduction

This study guide was developed for the purpose of assisting candidates for the National Association of Boards of Pharmacy (NABP) Multistate Pharmacy Jurisprudence Examination (MPJE). Because candidates will have been exposed, through the academic pharmacy degree program, to the federal and state laws subject to inquiry on the MPJE, this study guide is not intended to be a comprehensive collection or compilation of the text of those laws. Rather, it is a general overview of the relevant federal laws with which the candidate should be familiar.

2-1. Resources to Assist in Preparing for the MPJE

Information from NABP

The body of federal and state law, which the MPJE candidate must be knowledgeable about, is quite extensive. The candidate should begin the process of preparing for the MPJE by reviewing the MPJE competency statements provided in the NABP Registration Bulletin for the NAPLEX and MPJE exams. The bulletin is available on the NABP Web site at www.nabp.net. The MPJE statements are very valuable in focusing the candidate on the body of federal law to be reviewed and understood.

As to the body of state law, NABP offers two resources that may be beneficial to the MPJE candidate. More about each of these resources is available on the NABP Web site.

The first resource is the Survey of Pharmacy Law, published in CD-ROM format and available for purchase from NABP. The Survey is revised annually and provides summary information for individual states on various pharmacy law topics, including prescriptions (issuing, transmitting, and dispensing requirements); patient counseling; and pharmacy technicians. The Survey is composed of the following four sections.

• Organization

• Licensing law

• Drug law

• Census data

The second resource is NABPLAW Online. This resource is a searchable, electronic database of the pharmacy practice act and board of pharmacy rules for each of the 50 states. A free NABPLAW demo is available at the NABP Web site.

Candidates can purchase short-term access, varying from 1 day to 6 months. Time periods and prices can be viewed at the NABP Web site.

Information from Electronic Databases of Federal Law

Of great assistance to the MPJE candidate are online, electronic databases of federal law. The candidate is encouraged to use these databases as necessary during the review process. One of the greatest advantages (in addition to being no cost) of these electronic databases is the ability, through active links contained in the databases, to quickly retrieve and review cross-references to individual sections of the laws as well as to other relevant laws.

Because the "pharmacy law course" is taught at different times at colleges and schools of pharmacy, these electronic databases can be very beneficial. If the pharmacy law course was taught, for example, during the first year of the 4-year PharmD curriculum, the candidate may not have been exposed to all of the changes in federal pharmacy law that occurred over the following 3 years.

Because these databases are quite current, the candidate can achieve two objectives by reviewing the federal law databases:

• First, the candidate will be refreshed on laws studied previously in the pharmacy law course.

• Second, the candidate will be exposed to changes that have occurred since completing the pharmacy law course.

Accessing the Federal Food, Drug, and Cosmetic Act and the Federal Controlled Substances Act

Go to the U.S. Code Collection maintained by the Legal Information Institute of the Cornell University Law School. The Web site address for this collection is www4.law.cornell.edu/uscode.

When the Web page appears, scroll down and select Title 21. From the Web page that will next appear, you can access both the federal Food, Drug, and Cosmetic Act (FDCA) and the federal Controlled Substances Act (CSA).

Federal Food, Drug, and Cosmetic Act

On the Web page that appears, select Chapter 9, which is titled "Federal Food, Drug, and Cosmetic Act."

When the next Web page appears, you will see all nine subchapters that constitute the FDCA.

When you select a subchapter, you will then see on the next Web page the individual sections of the act contained in that subchapter or, in some cases, the individual parts contained in that subchapter.

Where the subchapter contains individual parts, selecting one part leads to a Web page with the individual sections contained in that part.

Federal Controlled Substances Act

The same Web page used to access the FDCA should be used to access the CSA, which is located at Chapter 13 instead of Chapter 9.

After selecting Chapter 13, use the same process as described for the FDCA.

Accessing the Regulations of the U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration

Go to the electronic Code of Federal Regulations (CFR) maintained by the U.S. Government Printing Office. The Web site address for this collection is www.gpoaccess.gov.

When the Web page appears, in the middle column under Executive Resources select "Code of Federal Regulations."

When the next Web page appears, select "Browse and/or search the CFR," which will take you to the CFR Titles. Scroll down and select "Title 21" and then select the most current date available. This will take you to a Web page that lists the individual parts of Title 21. Parts 1-99 through 800-1299 contain the regulations of the U.S. Food and Drug Administration (FDA). Beginning at Parts 1300-1399, you will find the regulations of the U.S. Drug Enforcement Administration (DEA).

The FDA regulations

The scope of the FDA regulations is significantly large, constituting literally thousands of pages. Therefore, the sections of FDA regulations have not been included in this guide, and the MPJE candidate should go to the GPO's CFR Web site, as described previously, for review.

The FDA regulations governing drugs begin at Part 200, which is found on the Web site at Parts 200-299. Thus, the candidate should select Parts 200-299 in the column with the heading "Browse Parts."

When the next Web page appears, the individual parts will appear. When you select any of the parts, the individual sections in that part will appear on the next Web page. FDA's regulations governing drugs continue into the next set of parts, specifically, Parts 300-499.

The set of parts that follow (500-599) contains FDA's regulations governing animal drugs and should be reviewed. The next set of parts (600-799) concerns two items, biologicals and cosmetics, and also should be reviewed. The final set of parts (800-1299) contains FDA's regulations governing medical devices and should be reviewed.

In reviewing these parts, the candidate need not read each word of every FDA regulation. To do so would require an unreasonable and unnecessary time commitment. It is anticipated that the candidate can recognize whether he or she needs to review the text of the section or move on to the next one.

The MPJE candidate can begin by opening Part 200 of the FDA regulations, as directed previously, and open the first section of Part 200. Then the candidate should recognize from the section title whether it contains (a) information about which the candidate is knowledgeable and does not require review or (b) information that is not subject to inquiry on the MPJE. In the presence of either of these, the candidate should move forward to the next section.

The DEA regulations

As with the FDA regulations, the scope of the DEA regulations is quite extensive, but fortunately the DEA regulations are more manageable than the FDA regulations.

In addition, if the candidate has worked in pharmacy practice to any degree, the DEA regulations likely will be more familiar to him or her than the FDA regulations, because the FDA regulations are not as directly related to daily pharmacy practice as are the DEA regulations.

The MPJE candidate can review each section of the relevant DEA regulations using the process described for the FDA regulations, beginning by opening Part 1300 and then each section in each part.

Information from Electronic Databases of State Law

Candidates for the MPJE are anticipated to have at least two resources for their study of relevant state law. The first of these is the textbook or other compilation of state law that was used in the pharmacy law course taught in the academic degree program. This first resource will, of course, be of value only if the candidate is taking the MPJE and seeking licensure as a pharmacist in the same state where the candidate completed the academic degree program.

The second is what is commonly referred to as the "state board of pharmacy law book." In many states, on submission of an application for examination for licensure as a pharmacist, the applicant will be provided a copy of the state board's pharmacy law book. The candidate may also have received as a final-year pharmacy student the Survey of Pharmacy Law described in the section on resources available from NABP.

In addition to these resources, as with federal law, a number of electronic databases are available for accessing state law. Most directly related to preparing for the MPJE is NABPLAW, described in the section on resources available from NABP. In addition to NABPLAW are various databases that are accessible free of charge.

The candidate should first look to his or her state's Internet home page for resources on state law. Although it is not possible to describe here how to find the relevant state law on each state's home page, the candidate will likely be able to successfully navigate through the state's Web pages.

As an example, the candidate can search to see if the state's secretary of state has an individual home page and, if it does, look on that home page for a link to state agency rules and regulations, such as those of the state board of pharmacy.

Beyond the state home page are legal resource Web sites that the candidate can use for accessing state law, again at no cost. The following Web sites may be useful to the candidate seeking additional information on not only state law, but also federal and other law:

• Rominger Legal: www.romingerlegal.com

• FindLaw: www.findlaw.com

• Law.com: www.law.com

• AllLaw.com: www.alllaw.com

• Georgia State University Law School Meta-Index: http://gsulaw.gsu.edu/metaindex

Information from Federal Agencies

The value of information available online from federal agencies should not be overlooked in preparing for the MPJE. Primary among these agencies are the FDA, the DEA, and the Consumer Product Safety Commission (CPSC).

The FDA Web site (www.fda.gov) contains many guides on pharmacy compounding, risk evaluation and mitigation strategies, and many other topics. The MPJE candidate should look specifically at the FDA Center for Drug Evaluation and Research Web site at www.fda.gov/cder.

The DEA Web site (www.dea.gov) offers a variety of materials, but the DEA Office of Diversion Control Web site (www.deadiversion.usdoj.gov) provides more information of relevance to the MPJE candidate. Included on the Diversion Control Web site is extensive information about registration requirements and selling of scheduled listed chemical products such as pseudoephedrine.

Requirements for pharmacy with respect to child-resistant packaging may be found on the CPSC Web site at www.cpsc.gov. The MPJE candidate should particularly review the CPSC publication "Poison Prevention Packaging: A Guide for Healthcare Professionals," available at www.cpsc.gov/CPSCPUB/PUBS/384.pdf.

Publications

At many colleges and schools of pharmacy, a textbook or other compilation of federal and state drug and pharmacy law may have been used in the pharmacy law course. Thus, the MPJE candidate may already have a resource that covers the laws subject to inquiry on the MPJE.

If not, other resources may be of assistance, including those from the reference list that follows. The first two references provide a practical, easy-to-understand explanation of the federal law subject to inquiry on the MPJE. The third reference provides a variety of state-specific (not all states are available) study guides in comprehensive and condensed versions. Resources from this reference will be particularly valuable to a candidate who earned the PharmD degree in a state different from the state in which he or she seeks licensure.

All of these references contain sample questions that will help the MPJE candidate gain experience in answering questions related to federal law and obtain a measure of knowledge prior to the MPJE.

References

Reiss BS, Hall GD. Guide to Federal Pharmacy Law. 6th ed. Boynton Beach, FL: Apothecary Press; 2009. Contact information: (888) 609-2665 or www.apothecarypress.com.

Strauss, S. Strauss' Federal Drug Laws and Examination Review. 5th ed. Boca Raton, FL: CRC Press; 2000. Contact information: (800) 272-7737 or www.crcpress.com.

State and federal pharmacy law study guides. Contact information: http://rxlaw.org.

2-2. The Comprehensive Drug Abuse Prevention and Control Act of 1970 and Regulations of the U.S. DEA

Introduction

The Comprehensive Drug Abuse Prevention and Control Act, enacted by Congress in 1970, has as its primary purpose preventing illicit manufacture, distribution, and use of controlled substances. This purpose is achieved through numerous requirements in the act and DEA regulations.

The Comprehensive Drug Abuse Prevention and Control Act, more commonly known as the Controlled Substances Act, establishes a "closed system" for distribution of drugs that are "controlled substances." The term closed system means controlled substances can be distributed only by and between persons registered with the DEA.

The DEA, a unit within the U.S. Department of Justice, was established in July 1973 by an executive reorganization plan; it replaced the former Bureau of Narcotics and Dangerous Drugs.

The FDA has also promulgated regulations that affect the distribution of controlled substances. One example is treatment programs for narcotic addicts. The FDA regulations contain medical guidelines for such programs, and the DEA regulations contain requirements for dispensing and recordkeeping activities for such programs.

Note that in 1988, Congress amended existing federal laws, including the CSA, with enactment of the Chemical Diversion and Trafficking Act. This act establishes recordkeeping and reporting requirements for persons who manufacture, distribute, import, or export a listed precursor or essential chemical, as well as tableting and encapsulating machines.

When the MPJE candidate studies the CSA and DEA regulations, the text added as a result of this 1988 act is generally easily recognized. For example, the DEA regulation at 21 CFR 1300.02 is titled "Definitions relating to listed chemicals."

The MPJE candidate needs to be attentive to how the CSA and DEA regulations govern commercially available controlled substances versus chemicals.

Another very important amendment to the CSA occurred in 2005 with enactment of the Combat Methamphetamine Epidemic Act (CMEA). The CMEA introduced a new category of substances (scheduled listed chemical products) and new sale and recordkeeping requirements for those products. Products in this category include ephedrine, pseudoephedrine, and phenylpropanolamine. DEA has promulgated several regulations (see Part 1314 of the DEA regulations) to implement the CMEA.

Also in 2005, the CSA was amended to allow private practice physicians (subject to being certified) to prescribe schedule III, IV, and V narcotic controlled substances for detoxification and maintenance treatment of opioid dependency. Currently two products, Suboxone and Subutex, may be prescribed for such treatment. For the MPJE candidate unfamiliar with the requirements for prescribing these controlled substances, information is available on the Web site of the Substance Abuse and Mental Health Services Administration at www.samhsa.gov.

Specific information about medication-assisted treatment may be found at www.dpt.samhsa.gov.

Several other developments have occurred in recent years, including DEA's promulgation of regulations to allow practitioners to issue multiple prescriptions for schedule II controlled substances and to allow electronic ordering (but not prescribing) of controlled substances. The MPJE candidate should be familiar with these and other recent developments in the federal laws governing controlled substances.

The CSA and DEA regulations are quite complex and technical, and they affect pharmacy practice significantly; thus, they demand thorough study by the MPJE candidate.

Key Provisions of the CSA

Access the CSA at the Web link (www4.law.cornell.edu/uscode) and follow the process listed earlier. There are two subchapters:

• I. Control and Enforcement

• II. Import and Export

The MPJE candidate should be familiar with both subchapters, particularly the following provisions from Subchapter I of the CSA. In addition, the MPJE candidate should review the sections in Subchapter II on import and export.

Subchapter I. Control and enforcement

Part A—Introductory provisions

000168 801. Congressional findings and declarations: controlled substances

This section sets forth the reasons Congress enacted the CSA. The MPJE candidate should be generally familiar with these findings and declarations.

000168 801a. Congressional findings and declarations: psychotropic substances

This section recognizes the international treaty—the Convention on Psychotropic Substances—that the United States entered into in 1971 and sets forth the reasons Congress implemented the convention. The MPJE candidate should be generally familiar with these findings and declarations.

000168 802. Definitions

The MPJE candidate should be familiar with all terms defined in this section of the CSA, which will aid in understanding the language of the sections that follow. Note the limitation in dispensing that results from the relationship between the definition of dispense and the definition of ultimate user. Note also that some of the definitions contain important substantive content, such as the definition of a regulated transaction and its placing of "thresholds" on the retail sale of ephedrine, pseudoephedrine, and phenylpropanolamine. Finally, note the definition of anabolic steroid as amended in 2004.

Part B—Authority to control; standards and schedules

000168 811. Authority and criteria for classification of substances

This section gives the U.S. attorney general the authority to add a drug to a schedule, transfer a drug between schedules, and remove a drug from a schedule. This section also contains the factors to consider when determining whether a drug should be placed in or removed from a schedule. This section also allows exclusion of a nonnarcotic substance from a schedule if the substance may be lawfully sold, under the FDCA, without a prescription. Finally, this section provides that dextromethorphan shall not be included in any schedule by reason of enactment of the CSA unless controlled after October 27, 1970, on the basis of the factors in this section.

000168 812. Schedules of controlled substances

This section establishes the five schedules (I-V) of controlled substances and the findings required for each schedule. The MPJE candidate should be familiar with these findings, such as that a schedule I controlled substance "has no currently accepted medical use in treatment."

000168 813. Treatment of controlled substance analogues

This section provides that a controlled substance analogue, to the extent intended for human use, shall be treated as a controlled substance in schedule I.

000168 814. Removal of exemption of certain drugs

This section, among other things, allows the U.S. attorney general to remove from exemption—see definition (39)(A)(iv) at section 802 concerning ephedrine, pseudoephedrine, and phenylpropanolamine—a drug or group of drugs that is being diverted to obtain a listed chemical for use in illicit production of controlled substances.

Part C—Registration of manufacturers, distributors, and dispensers of controlled substances

000168 821. Rules and regulations

This section authorizes the U.S. attorney general to promulgate rules and regulations and to charge reasonable fees relating to the registration and control of regulated persons and transactions.

000168 822. Persons required to register

This section sets forth the registration requirements for persons who handle controlled substances. The MPJE candidate should understand who is and who is not required to obtain a registration, that a separate registration is required for separate locations, and that an inspection may be conducted prior to granting a registration.

000168 823. Registration requirements

This section provides specific detail regarding registration of practitioners, including pharmacies but not pharmacists, and the factors to be considered in determining whether to grant a registration.

000168 824. Denial, revocation, or suspension of registration

This section lists the grounds for denying, suspending, or revoking a registration. Note that a suspension or revocation may be limited to a particular schedule or schedules and that the registration can be revoked simultaneously with initiation of proceedings (issuing an "order to show cause") if there is an imminent danger to public health or safety.

000168 825. Labeling and packaging

This section establishes the labeling requirements for commercial containers of controlled substances.

000168 826. Production quotas for controlled substances

This section authorizes the U.S. attorney general to determine and establish production quotas for schedule I and II controlled substances to be manufactured each calendar year to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks.

000168 827. Records and reports of registrants

This section establishes requirements for the biennial inventory (in relation to May 1, 1971) and for the addition of any newly scheduled drug to the existing inventory. This section requires every registrant to maintain a complete and accurate record of each controlled substance received, sold, delivered, or otherwise disposed of, but it does not require a perpetual inventory. The MPJE candidate should recognize the exceptions to the inventory requirement. Note also the recently added reporting requirements for gamma hydroxybutyric acid.

000168 828. Order forms

This section establishes the requirement that distribution of schedule I and II controlled substances occur only pursuant to a form issued by the U.S. attorney general (the DEA 222 Form). It also lists recordkeeping requirements for the form. As a related item, the MPJE candidate should be sure to review the new DEA regulations on "electronic orders" for controlled substances in Parts 1305 and 1311 of the DEA regulations.

000168 829. Prescriptions

This section sets forth the prescription requirements for each schedule of controlled substances and notes that schedule V controlled substances, when not dispensed pursuant to a prescription, may be sold only for a medical purpose.

000168 830. Regulation of listed chemicals and certain machines

This section establishes the recordkeeping and reporting requirements for those engaged in activities related to listed chemicals and tableting and encapsulating machines.

Part D—Offenses and penalties

000168 841. Prohibited acts A

This section and the next two sections list unlawful acts and the penalties associated with these acts. It is important for the MPJE candidate to recognize that some of the listed unlawful acts apply to all persons, whereas others apply only to registrants. The MPJE candidate should recognize what acts are unlawful and generally be familiar with the associated penalties.

000168 842. Prohibited acts B

See note to section 841.

000168 843. Prohibited acts C

See note to section 841.

000168 844. Penalties for simple possession

This section makes possession by any person (including a registrant) of a controlled substance or listed chemical unlawful unless allowed under the CSA. It also establishes penalties for unlawful possession and defines what is meant by a "drug, narcotic, or chemical offense."

000168 844a. Civil penalty for possession of small amounts of certain controlled substances

This section provides penalties for any person (including a registrant) for unlawful possession of "personal use amounts" as specified by the U.S. attorney general by regulation.

000168 846. Attempt and conspiracy

This section provides that persons who "attempt" or "conspire" to commit a controlled substance offense are subject to the same penalties as prescribed for the offense.

000168 847. Additional penalties

This section provides that any criminal penalties imposed for violation of the CSA do not preclude other civil and administrative penalties, such as monetary fines under the federal Civil Monetary Penalties Law or suspension or revocation of a DEA Certificate of Registration.

000168 848. Continuing criminal enterprise

This section defines a continuing criminal enterprise and imposes very severe penalties—including life imprisonment and the death penalty—for those convicted of engaging in such an enterprise. The MPJE candidate should recognize that the text of this section includes other offenses that are not considered a continuing criminal enterprise. For example, this section provides the penalty for any person who during the commission of, in furtherance of, or while attempting to avoid apprehension, prosecution, or service of a prison sentence for a felony violation of the CSA intentionally kills, or counsels, commands, induces, procures, or causes the intentional killing of, any federal, state, or local law enforcement officer engaged in, or on account of, the performance of such officer's official duties. If such killing results, that person may be sentenced to any term of imprisonment, which shall not be less than 20 years and may be up to life imprisonment, or he or she may be sentenced to death.

000168 849. Transportation safety offenses

This section doubles the penalty for the first conviction and triples the penalty for subsequent convictions of certain controlled substance offenses in a rest area or truck stop, as these terms are defined in this section.

000168 850. Information for sentencing

This section, unless provided otherwise in another federal law, establishes that no limitation be placed on the information concerning the background, character, and conduct of a person convicted of a controlled substance offense that may be received and considered for purposes of imposing an appropriate sentence.

000168 851. Proceedings to establish prior convictions

This section sets forth the process for establishing that a person has prior convictions of a controlled substance offense or offenses.

000168 852. Application of treaties and other international agreements

This section provides that no treaties and other international agreements entered into by the United States shall limit the provision of treatment, education, or rehabilitation as alternatives to conviction or criminal penalty for offenses involving any drug or other substance subject to a treaty or agreement.

000168 853. Criminal forfeitures

This section provides that persons convicted of controlled substance offenses shall forfeit to the United States all real and personal property constituting or derived from any proceeds the person obtained, directly or indirectly, as the result of the offense and any of the person's property used, or intended to be used, in any manner or part, to commit or to facilitate the commission of the offense.

000168 854. Investment of illicit drug profits

This section makes it unlawful for a person to use or invest in certain enterprises, as defined in this section, any income derived, directly or indirectly, from a violation of the CSA that is punishable by imprisonment for more than 1 year, provided that the person participated as a principal in the violation. It also provides penalties for making such investments.

000168 855. Alternative fine

This section provides that, in lieu of a fine otherwise authorized by Part D, a defendant who derives profits or other proceeds from an offense may be fined not more than twice the gross profits or other proceeds.

000168 856. Maintaining drug-involved premises

This section makes unlawful knowingly opening or maintaining any place for the purpose of manufacturing, distributing, or using any controlled substance, as well as managing or controlling any building, room, or enclosure, whether as an owner, lessee, agent, employee, or mortgagee, and knowingly and intentionally renting, leasing, or making available for use, with or without compensation, the building, room, or enclosure for the purpose of unlawfully manufacturing, storing, distributing, or using a controlled substance. It also establishes penalties for a violation.

000168 858. Endangering human life while illegally manufacturing controlled substance

This section provides that whoever, while unlawfully manufacturing a controlled substance or attempting to do so, or while transporting or causing to be transported materials, including chemicals, to do so, creates a substantial risk of harm to human life shall be subject to a fine and imprisonment.

000168 859. Distribution to persons under age 21

This section provides enhanced penalties for first and second offenses of a person who is at least 18 years of age unlawfully distributing a controlled substance to a person under 21 years of age.

000168 860. Distribution or manufacturing in or near schools and colleges

This section provides enhanced penalties for first and second offenses of any person who is unlawfully distributing, possessing with intent to distribute, or manufacturing a controlled substance in or on, or within 1,000 feet of, the real property comprising a public or private elementary, vocational, or secondary school; a public or private college, junior college, or university; a playground; or a housing facility owned by a public housing authority. The enhanced penalties also apply if the offense takes place within 100 feet of a public or private youth center, public swimming pool, or video arcade facility. This section also makes it an offense for any person at least 21 years of age to knowingly and intentionally employ, hire, use, persuade, induce, entice, or coerce a person under 18 years of age to violate this section or to knowingly and intentionally employ, hire, use, persuade, induce, entice, or coerce a person under 18 years of age to assist in avoiding detection or apprehension for any offense under this section by any federal, state, or local law enforcement official.

000168 860a. Consecutive sentence for manufacturing or distributing, or possessing with intent to manufacture or distribute, methamphetamine on premises where children are present or reside

This section provides additional penalties for anyone manufacturing or distributing methamphetamine or its salts, isomers, or salts of isomers on premises in which an individual under 18 is present or resides.

000168 861. Employment or use of persons under 18 years of age in drug operations

This section makes it unlawful for any person at least 18 years of age to knowingly and intentionally (a) employ, hire, use, persuade, induce, entice, or coerce a person under 18 years of age to violate any provision of the CSA; (b) employ, hire, use, persuade, induce, entice, or coerce a person under 18 years of age to assist in avoiding detection or apprehension for any offense of the CSA by any federal, state, or local law enforcement official; or (c) receive a controlled substance from a person under 18 years of age, other than an immediate family member, in violation of the CSA. This section also establishes penalties for first and subsequent violations of this section. In addition, this section makes it unlawful to knowingly provide or distribute a controlled substance or a controlled substance analogue to a person under 18 years of age or to a pregnant person.

000168 862. Denial of federal benefits to drug traffickers and possessors

This section provides for denial of federal benefits to drug traffickers and possessors, with differences in denial based on whether the person is a drug trafficker or drug possessor.

000168 862a. Denial of assistance and benefits for certain drug-related convictions

This section provides for denial of federal benefits and assistance to an individual convicted under federal or state law of any offense that is classified as a felony by the law of the jurisdiction involved and that has as an element of the offense the possession, use, or distribution of a controlled substance.

000168 862b. Sanctioning for testing positive for controlled substances

This section provides that the federal government shall not prohibit states from testing welfare recipients for use of controlled substances or from sanctioning welfare recipients who test positive for use of controlled substances.

000168 863. Drug paraphernalia

This section makes unlawful a number of activities with respect to drug paraphernalia, establishes penalties for violations, and defines drug paraphernalia.

000168 864. Anhydrous ammonia

This section makes unlawful the stealing of anhydrous ammonia or transporting stolen anhydrous ammonia across state lines, knowing, intending, or having reasonable cause to believe that such anhydrous ammonia will be used to manufacture a controlled substance in violation of this part.

000168 865. Smuggling methamphetamine or methamphetamine precursor chemicals into the United States while using facilitated entry programs

This section provides an enhanced prison sentence for a person convicted of an offense involving methamphetamine when the person convicted was enrolled in, or acting on behalf of a person enrolled in, any dedicated commuter lane, alternative or accelerated inspection system, or other facilitated entry program into the United States, or when the person committed the offense while entering the United States using such a lane, system, or program.

Parts E and F

The last two parts (Part E and Part F) of Subchapter I contain a variety of sections, many of which are not of interest to the MPJE candidate. As directed in the introduction to this study guide, the candidate should open each part and from the titles of the sections in each part determine those that he or she should review.

Subchapter II. Import and export

This subchapter of the CSA contains several sections governing the importation and exportation of controlled substances, including requirements for registration of importers and exporters. The MPJE candidate should review these sections and be generally knowledgeable about the content.

Regulations of the DEA

The DEA regulations may be found in Title 21 of the CFR. The body of DEA regulations is divided into 17 parts.

The MPJE candidate should review relevant DEA regulations on the electronic database as described in the introduction to this study guide. Following is a very basic summary of the content of each part.

Part 1300—Definitions

The DEA regulations begin at Part 1300 of Title 21 of the CFR. Part 1300 has two sections, both of which contain definitions of terms related to controlled substances and to listed chemicals. Because there are many definitions, they are not included here, but as noted previously for definitions contained in the CSA, the MPJE candidate should retrieve and review all of the definitions contained in the two sections of Part 1300. Some of these definitions are quite extensive and contain very important information for the MPJE candidate. For example, restrictions related to the sale of scheduled listed chemical products are found in the definition of regulated transaction at 21 CFR 1300.02.

Part 1301—Registration of manufacturers, distributors, and dispensers of controlled substances

Part 1301 governs the many aspects of registration with the DEA. This part includes the sections related to who is required to register, how one applies for registration, what exemptions exist to registration, and what allowances are made for importation for personal use. Also included are specific details about the DEA Certificate of Registration and the number assignment, procedure for suspension or revocation of a registration, and modification or termination of a registration. A very useful chart listing registration categories, fees, periods, and application form numbers is available at www.deadiversion.usdoj.gov/drugreg/categories.htm. The MPJE candidate should be familiar with each of these aspects of registration.

Very importantly, requirements for security, including the prohibition of employing certain individuals, are included in this part. The MPJE candidate should study this part in detail, paying particular attention to sections 1301.27 and 1301.28, both added in 2005. Although not included specifically in the DEA regulations, the method for determining the legitimacy of a DEA registration number is important for the MPJE candidate and thus is described immediately below.

Before October 1, 1985, DEA Certificate of Registration numbers for practitioners began with the letter "A." Since that date, the DEA Certificate of Registration numbers for practitioners begin with the letter "B." Further, a DEA Certificate of Registration number issued to a midlevel practitioner begins with the letter "M." Following the first letter is a second letter, which is the first letter of the registrant's last name. Following the two letters is a seven-digit computer-generated sequential number. The number is constructed so that it can be tested for verification by using the following formula:

• Step 1: Determine the sum of the first, third, and fifth digits.

• Step 2: Determine the sum of the second, fourth, and sixth digits, and then multiply the sum by two.

• Step 3: Determine the sum of the two numbers determined in steps 1 and 2.

• Step 4: The last digit of this third sum should be the same as the last digit of the seven-digit DEA Certificate of Registration number.

Part 1302—Labeling and packaging requirements for controlled substances

Part 1302 contains the requirements for labeling of the "commercial container" of a controlled substance. The MPJE candidate should be generally familiar with these requirements.

Part 1303—Quotas

Part 1303 contains the sections related to the establishment of production and procurement quotas for schedule I and II controlled substances for the estimated medical, scientific, research, and industrial needs. The MPJE candidate should be generally familiar with the sections in this part.

Part 1304—Records and reports of registrants

Part 1304 contains the many requirements associated with recordkeeping in relation to the various aspects of handling controlled substances by practitioners, including narcotic treatment programs. Also included in this part are the requirements associated with inventories of controlled substances, including the "biennial inventory." The MPJE candidate should be very familiar with the sections in this part.

Part 1305—Orders for schedule I and II controlled substances

Part 1305 includes the sections describing the DEA Form 222 for ordering schedule II controlled substances. Also included in this part are the details associated with the granting of a power of attorney to authorize individuals to execute order forms and electronic orders. The MPJE candidate should be very familiar with the sections in this part and should be sure to review the regulations added in 2005 regarding electronic orders for controlled substances.

Part 1306—Prescriptions

Part 1306 contains the sections concerning the many details of issuing, dispensing, and labeling of prescriptions for controlled substances. Also included in this part in relation to prescriptions are the requirements for electronic recordkeeping of prescription refills and for transfer of prescriptions between pharmacies. Finally, this part includes the requirements for the sale of controlled substances that are not "prescription drugs." The MPJE candidate should be very familiar with the sections in this part and should be sure to review the new regulations added in 2005 regarding prescribing of some controlled substances for narcotic treatment, as well as the requirements added more recently at sections 1306.12(b) and 1306.14(e) regarding issuing of multiple prescriptions for a schedule II controlled substance.

Part 1307—Miscellaneous

Part 1307 contains a few sections of interest to the MPJE candidate. Of particular note are the sections on "distribution" by dispensers and disposal of controlled substances.

Part 1308—Schedules of controlled substances

Part 1308 describes the "Administration Controlled Substances Number" and its uses and lists controlled substances in their respective schedules. Part 1308 also provides for "exempt" and "excluded" substances, control of immediate precursors, and emergency scheduling. The MPJE candidate should be generally familiar with controlled substances and the schedule into which they have been placed, as well as those products that are exempt and excluded, as described in Part 1308.

Part 1309—Registration of manufacturers, distributors, importers, and exporters of List I chemicals

Part 1309 includes several provisions related to those engaged in activities with List I chemicals. Although Part 1309 does not generally affect the practice of pharmacy, the MPJE candidate should review these sections for familiarity.

Part 1310—Records and reports of listed chemicals and certain machines

Although some sections of Part 1310 also do not generally affect the practice of pharmacy, some sections in Part 1310 relate to ephedrine, and thus this part deserves review by the MPJE candidate.

Part 1311—Digital certificates

Part 1311 was added in 2005. It governs digital certificates in association with electronic orders for controlled substances, and the MPJE candidate should study it in detail.

Part 1312—Importation and exportation of controlled substances

Part 1312 includes several provisions related to those engaged in importing and exporting controlled substances. Although this part does not generally affect the practice of pharmacy, the MPJE candidate should review these sections for familiarity.

Part 1313—Importation and exportation of list I and list II chemicals

Part 1313 includes several provisions related to those engaged in importing and exporting precursors and essential chemicals. Although this part does not generally affect the practice of pharmacy, the MPJE candidate should review these sections for familiarity.

Part 1314—Retail sale of scheduled listed chemical products

Part 1314 is of importance to pharmacy because it sets forth the many requirements associated with retail sales of scheduled listed chemical products. The MPJE candidate should be very familiar with the details of selling these products at retail, including restrictions on quantity, recordkeeping requirements, staff training requirements, and the annual self-certification process.

Part 1315—Importation and production quotas for ephedrine, pseudoephedrine, and phenylpropanolamine

Part 1315 includes more provisions on scheduled listed chemical products, including a personal use exemption. Although this part does not generally affect the practice of pharmacy, the MPJE candidate should review these sections for familiarity.

Part 1316—Administrative functions, practices, and procedures

Part 1316 contains several sections that address inspections, probable cause, and other issues related to warrants, matters related to research, procedures for hearings, burden of proof, and miscellaneous other matters. The MPJE candidate should be generally familiar with these matters.

2-3. The Food, Drug, and Cosmetic Act of 1938 and Regulations of the U.S. FDA

Introduction

The Food, Drug, and Cosmetic Act, enacted by Congress in 1938, has as its primary purpose preventing interstate distribution of foods, drugs, cosmetics, and devices that are adulterated or misbranded. This purpose is achieved through numerous requirements in the act and FDA regulations.

The MPJE candidate should be familiar with the historical development of the FDCA, and its predecessor, the Pure Food and Drug Act of 1906. The candidate should also be familiar with amendments to the FDCA since 1938, including the following:

• Durham-Humphrey Amendment of 1951

• Kefauver-Harris Amendment of 1962

• Medical Device Amendment of 1976

• Orphan Drug Act of 1983

• Drug Price Competition and Patent Term Restoration Act of 1984

• Prescription Drug Marketing Act of 1987

• Safe Medical Devices Act of 1990

• Dietary Supplement Health and Education Act of 1994

• Food and Drug Administration Modernization Act of 1997

• Best Pharmaceuticals for Children Act of 2002

• Medical Device User Fee and Modernization Act of 2002

• Pediatric Research Equity Act of 2003

• Minor Use and Minor Species Animal Health Act of 2004

• Food Allergen Labeling and Consumer Protection Act of 2004

• Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006

• Food and Drug Administration Amendments Act of 2007

Key Provisions of the FDCA

The FDCA is located at Chapter 9 of Title 21 of the United States Code. Chapter 9 has the following nine subchapters:

I. Short Title

II. Definitions

III. Prohibited Acts and Penalties

IV. Food

V. Drugs and Devices

VI. Cosmetics

VII. General Authority

VIII. Imports and Exports

IX. Miscellaneous

The MPJE candidate should be particularly familiar with Subchapters II, III, V (which is divided into Subparts A through E), and VI and with the following sections within the subchapters of the FDCA.

Subchapter II. Definitions

000168 321. Definitions; generally

The MPJE candidate should be familiar with all terms defined in this section of the FDCA, which will aid in understanding the language of the sections that follow. The candidate also should be able to distinguish between terms such as drug, counterfeit drug, new drug, device, dietary supplement, food, and cosmetic.

Subchapter III. Prohibited acts and penalties

000168 331. Prohibited acts

The MPJE candidate should be familiar with conduct that is prohibited by the FDCA, as set forth in this section.

000168 332. Injunction proceedings

This section provides that the U.S. district courts and all courts exercising jurisdiction in U.S. territories have jurisdiction to enjoin violations of section 331, with some exceptions as set forth in this section. Furthermore, an alleged violation of an injunction or restraining order shall, upon demand of the accused, be tried before a jury.

000168 333. Penalties

The penalties for violation of the FDCA range from not very severe to very severe. The MPJE candidate should be familiar with the penalties, and particularly those related to the prescription drug marketing violations (i.e., drug samples) and distribution of human growth hormone. Notice the use of the term knowingly, as defined in section 321.

000168 334. Seizure

This section describes the process related to seizure and disposition of adulterated and misbranded foods, drugs, and cosmetics, a process with which the MPJE candidate should be familiar.

000168 335. Hearing before report of criminal violation

This section provides that before any violation of this chapter is reported to a U.S. attorney for criminal proceedings, the person against whom the proceeding is contemplated shall be given appropriate notice and an opportunity to present his or her views, either orally or in writing.

000168 335a. Debarment, temporary denial of approval, and suspension

This section describes the "debarment" from submitting or assisting in the submission of applications for drug approvals of businesses and individuals based on prior misconduct related to the drug approval process. The MPJE candidate should be able to distinguish the various characteristics of mandatory and permissive debarments.

000168 335b. Civil penalties

This section continues the matter of misconduct in the drug approval process. The MPJE candidate should be familiar with the conduct prohibited and the associated penalties, together with the provision concerning informants.

000168 335c. Authority to withdraw approval of abbreviated drug applications

This section authorizes the withdrawal of approval of abbreviated drug applications if the approval was obtained, expedited, or otherwise facilitated through bribery, payment of an illegal gratuity, or fraud or material false statement. Withdrawal is also authorized if the manufacturer has repeatedly demonstrated a lack of ability to produce the drug for which the application was submitted in accordance with the formulations and manufacturing processes set forth in the application and has introduced, or attempted to introduce, such adulterated or misbranded drug into commerce. This section also provides procedures for withdrawals.

000168 336. Report of minor violations

This section provides that the secretary of Health and Human Services (HHS) is not required to report for prosecution, or for the institution of libel or injunction proceedings, minor violations of this chapter whenever he or she believes that the public interest will be adequately served by a suitable written notice or warning.

000168 337. Proceedings in the name of United States; provision as to subpoenas

This section requires that legal proceedings for enforcement or restraint of violations be in the name of the United States. However, this section also allows states to bring actions under the act, but only upon notice being given to the HHS secretary as set forth in this section.

Subchapter IV. Food

Although this subchapter is titled "Food," the MPJE candidate should review select sections because they contain requirements related to dietary supplements. The MPJE candidate should review the portions addressing dietary supplements in the following sections: 341, 342, 343, 343-1, 343-2, and 350-b. In addition, the MPJE candidate should review section 350 on vitamins and minerals.

Subchapter V. Drugs and devices

Part A—Drugs and devices

000168 351. Adulterated drugs and devices

A drug or device can be "adulterated" for several reasons, as listed in this section. The MPJE candidate should be familiar with these reasons.

000168 352. Misbranded drugs and devices

A drug or device can be "misbranded" for several reasons, as listed in this section. The MPJE candidate should be familiar with these reasons.

000168 353. Exemptions and consideration for certain drugs, devices, and biological products

A key section of the FDCA, this section, among other things, exempts legend drugs from the general labeling requirements of the FDCA, including when sold when a prescription is presented. (Note the label requirement of the "Rx Only symbol," which replaces the labeling requirement of "Caution: Federal law prohibits dispensing without a prescription," a change created by the Food and Drug Administration Modernization Act of 1997.) Also included in this section are the sales restrictions imposed by the Prescription Drug Marketing Act of 1987 with respect to legend drug samples and coupons for legend drugs, together with the wholesaler licensing requirements. Finally, this section addresses drugs for veterinary use.

000168 353a. Pharmacy compounding

This section was added to the FDCA by the Food and Drug Administration Modernization Act of 1997. However, in an April 29, 2002, opinion, the U.S. Supreme Court ruled the section unconstitutional in the case of Thompson et al. v. Western States Medical Center et al., 535 U.S. 357. Other sections of the FDCA address pharmacy compounding, however. The MPJE candidate should be very familiar with the federal law on pharmacy compounding. A good source for the U.S. Supreme Court opinion and other materials, particularly the FDA Compliance Policy Guidance on pharmacy compounding, is the FDA's Center for Drug Evaluation and Research at www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm. The MPJE candidate should be certain to review the FDA compliance guide on pharmacy compounding, available at www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM118050.pdf.

000168 354. Veterinary feed directive drugs

This section defines what is meant by a veterinary feed directive drug and sets forth requirements in relation to use and labeling of such drugs.

000168 355. New drugs

This quite lengthy section sets forth the requirements and process for approval of a "new drug" through filing of a new drug application or abbreviated new drug application. The MPJE candidate should be familiar with the process for approval of drugs and note particularly in this section the definition and use of the terms bioavailability and bioequivalent. The references listed in the introduction to this study guide provide a good overview of the drug approval process.

000168 355a. Pediatric studies of drugs

This section authorizes the HHS secretary to request pediatric studies, which are defined in this section, from the holder of an approved application for a new or previously approved drug, where the drug may produce health benefits in the pediatric population. If the holder of the approved application completes the studies, the holder will be granted additional "market exclusivity," through extension of patent life for the periods described in this section, for the drug. Finally, this section establishes requirements relative to the conducting of pediatric studies.

000168 355b. Adverse-event reporting

This section requires that the label of a prescription drug contain a toll-free number maintained by HHS to receive reports of adverse events regarding drugs.

000168 355c. Research into pediatric uses for drugs and biological products

This section contains several requirements in relation to assessing the safety and effectiveness of drugs and biological products in pediatric patients and to support dosing and administration of drugs and biological products in pediatric patients.

000168 356. Fast-track products

This section authorizes the HHS secretary, at the request of the sponsor of a new drug, to facilitate the development and expedite the review of the drug if it is intended for the treatment of a serious or life-threatening condition and if it demonstrates the potential to address unmet medical needs for such a condition, which serves as the definition of a fast-track product.

000168 356a. Manufacturing changes

This section describes manufacturing changes and sets forth those changes that require filing of a supplemental application and those that do not.

000168 356b. Reports of postmarketing studies

This section establishes the requirements for postmarketing studies where the sponsor of a drug has entered into an agreement with the HHS secretary to conduct such a study.

000168 356c. Discontinuance of life-saving drug

This section creates the requirement that the sole manufacturer of a drug that has an approved application and that was not originally derived from human tissue and was replaced with recombinant product, and that is life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition, notify the HHS secretary of discontinuance of manufacture of the product at least 6 months prior to the discontinuance date. Reduction in the 6-month notice requirement is authorized in certain circumstances, as described in this section.

000168 358. Authority to designate official names

This section authorizes the HHS secretary to designate an official name for a drug or device, except where the official name infringes a valid trademark. It also contains a requirement that the HHS secretary review official names in the United States Pharmacopoeia, the Homoeopathic Pharmacopoeia, and the National Formulary to determine whether revision of those names is necessary or desirable. Finally, in such reviews, the HHS secretary is required to make determinations in relation to the designation of an official name on the basis of complexity, usefulness, multiplicity, or lack of a name.

000168 359. Nonapplicability of subchapter to cosmetics

As the title of this section states, nothing in this subchapter applies to cosmetics, unless the cosmetic is also a drug or device or component of a drug or device.

000168 360. Registration of producers of drugs or devices

This section establishes the registration and drug listing and National Drug Code requirements for drug manufacturers. The MPJE candidate should be familiar with the National Drug Code system. Significantly, this section, at (g)(1), exempts pharmacies and certain others from the registration and drug listing requirements under the conditions stated.

000168 360b. New animal drugs

As with drugs for human use, the MPJE candidate should be familiar with new animal drugs under the FDCA, as described in this lengthy section.

000168 360c. Classification of devices intended for human use

The MPJE candidate should be familiar with the FDCA provisions related to devices. This section establishes three classes of devices, as follows.

• Class I: General controls

• Class II: Special controls

• Class III: Premarket approval

This section also sets forth the standards for determination of the safety and effectiveness of a device and provides for classification panel organization and operation.

000168 360d. Performance standards

This section establishes performance standards for class II—and in some cases class III—devices and the procedures for establishing and recognizing the standards.

000168 360e. Premarket approval

This section establishes the requirements and procedures for an application for premarket approval of a class III device.

000168 360f. Banned devices

This section authorizes the HHS secretary to promulgate regulations to ban certain devices, as described in this section.

000168 360g. Judicial review

This section sets forth the procedures for judicial review of decisions of the HHS secretary with regard to devices.

000168 360h. Notification and other remedies

This section provides that when a device presents an unreasonable risk of substantial harm and notification is necessary to eliminate the risk of harm, the HHS secretary may issue an order to ensure that adequate notification is provided, in an appropriate form, by the persons and means best suited under the circumstances involved to all health professionals who prescribe or use the device and to any other person (including manufacturers, importers, distributors, retailers, and device users) who should properly receive such a notification to eliminate such a risk. This section also authorizes the HHS secretary to order the manufacturer of a device to repair, replace, or make refund for the device. Finally, this section gives the HHS secretary authority to order a recall of a device.

000168 360i. Records and reports on devices

This section requires reports, as described in the section, from device manufacturers and device-user facilities, such as hospitals. It also authorizes the HHS secretary to order a device manufacturer to adopt a method for tracking certain class II and III devices.

000168 360j. General provisions respecting control of devices intended for human use

This section contains a variety of requirements, including provisions for custom devices, restricted devices, good manufacturing practice requirements, and exemption of devices for investigational use.

000168 360k. State and local requirements respecting devices

This section establishes the relationship between the FDCA provisions on devices and any state laws that may exist in relation to devices.

000168 360l. Postmarket surveillance

This section authorizes the HHS secretary to impose on manufacturers of certain devices various postmarketing surveillance requirements related to devices.

000168 360m. Accredited persons

This section requires the HHS secretary to establish an accreditation program as described in the section, for persons who review reports related to devices.

Part B—Drugs for rare diseases or conditions

000168 360aa. Recommendations for investigations of drugs for rare diseases or conditions

This section provides that a sponsor of a drug for a disease or condition that is rare may request the HHS secretary to provide written recommendations for the nonclinical and clinical investigations that must be conducted with the drug before it may be approved for treatment of such a disease or condition or, if the drug is a biological product, before it may be licensed for such disease or condition.

000168 360bb. Designation of drugs for rare diseases or conditions

This section allows a manufacturer or sponsor of a drug to request, prior to submission of an application for approval, the HHS secretary to designate the drug as a drug for a rare disease or condition. This section defines a rare disease or condition as any disease or condition that affects (a) fewer than 200,000 persons in the United States or (b) more than 200,000 persons in the United States provided that there is no reasonable expectation that the cost of developing and making available in the United States a drug for such a disease or condition will be recovered from sales in the United States. It also contains a requirement for notice to the HHS secretary for discontinuance of production of the drug.

000168 360cc. Protection for drugs for rare diseases or conditions

This section provides that if the HHS secretary approves an application for a drug designated for a rare disease or condition, the HHS secretary may not approve another application for such a drug for such a disease or condition for a person who is not the holder of the approved application until the expiration of 7 years from the date of approval, unless (a) the holder of the approved application cannot ensure the availability of sufficient quantities of the drug to meet the needs of people with the disease or condition for which the drug was designated or (b) the holder provides the HHS secretary written consent for the approval of other applications before the expiration of the 7-year period.

000168 360dd. Open protocols for investigations of drugs for rare diseases or conditions

This section provides, under certain circumstances, for the HHS secretary to encourage the sponsor of a drug designated for a rare disease or condition to design protocols for clinical investigations of the drug that may be conducted to permit the addition to the investigations of people with the disease or condition who need the drug to treat the disease or condition and who cannot be satisfactorily treated by available alternative drugs.

000168 360ee. Grants and contracts for development of drugs for rare diseases and conditions

This section authorizes the HHS secretary to make grants to and enter into contracts with public and private entities and individuals to assist in defraying the costs of qualified testing expenses incurred in connection with the development of drugs for rare diseases and conditions, of development of medical devices for rare diseases or conditions, and of development of medical foods (a food formulated to be consumed or administered enterally under the supervision of a physician) for rare diseases or conditions.

Part D—Dissemination of treatment information

When sections 360aaa-360aaa-6 were enacted, Congress provided that they were to sunset (cease effectiveness) in 2006. Related to this, the FDA has published a "guidance for industry" on good reprint practices. The guidance is available at www.fda.gov/oc/op/goodreprint.html. Although the text of the sections remains in the U.S. Code, rather than review the sections, the MPJE candidate should review the FDA guidance to gain general understanding of requirements and limitations associated with dissemination of treatment information.

Part E—General provisions relating to drugs and devices

000168 360bbb. Expanded access to unapproved therapies and diagnostics

This section authorizes the HHS secretary to allow shipment of investigational drugs or investigational devices for the diagnosis, monitoring, or treatment of a serious disease or condition in emergency situations. Furthermore, an individual patient, acting through a physician, may request from a manufacturer or distributor an investigational drug or device for the diagnosis, monitoring, or treatment of a serious disease or condition if a number of conditions, as set forth in this section, are fulfilled.

000168 360bbb-1. Dispute resolution

This section requires the HHS secretary to establish a procedure for a sponsor, applicant, or manufacturer to obtain a review, including by a scientific advisory panel, in situations in which there is a scientific controversy with the HHS secretary.

000168 360bbb-2. Classification of products

This section provides that a person submitting an application for a product may submit a request to the HHS secretary with respect to the classification of the product as a drug, biological product, device, or a combination or with respect to the component of the FDA that will regulate the product. In submitting the request, the person shall recommend a classification for the product or a component to regulate the product, as appropriate. This section also describes what action the HHS secretary shall take in response to filing of such a request.

000168 360bbb-3. Authorization for medical products for use in emergencies

This section provides for the use of unapproved drugs, devices, and biological products and for the use of approved drugs, devices, and biological products for unapproved uses in the event of an emergency.

Part F—New animal drugs for minor use and minor species

000168 360ccc. Conditional approval of new animal drugs for minor use and minor species

This section authorizes conditional approval of a new animal drug for a minor use or a minor species. Included are the requirements associated with application for approval and limitations on seeking approval.

000168 360ccc-1. Index of legally marketed unapproved new animal drugs for minor species

This section requires the secretary of HHS to establish a list of (a) new animal drugs intended for use in a minor species for which there is a reasonable certainty that the animal or edible products from the animal will not be consumed by humans or food-producing animals and (b) new animal drugs intended for use only in a hatchery, tank, pond, or other similar contained human-made structure in an early, nonfood life stage of a food-producing minor species, where safety for humans is demonstrated.

000168 360ccc-2. Designated new animal drugs for minor use or minor species

This section provides that the manufacturer or sponsor of a new animal drug for a minor use or use in a minor species may request the secretary of HHS to declare that drug a designated new animal drug.

Subchapter VI. Cosmetics

The MPJE candidate should review the three sections (361-363) contained in this subchapter on cosmetics.

The last three subchapters of Chapter 9 contain a variety of sections, many of which are not of interest to the MPJE candidate. As directed in the explanation to the study guide, the candidate should open each subchapter and from the titles of the parts and sections determine those that the MPJE candidate should review.

Regulations of the U.S. FDA

The FDA regulations may be found in Title 21 of the CFR. The body of FDA regulations is divided into subchapters as follows:

• Subchapter A—General (21 CFR Parts 1-99)

• Subchapter B—Food for Human Consumption (21 CFR Parts 100-199)

• Subchapter C—Drugs: General (21 CFR 200-299)

• Subchapter D—Drugs for Human Use (21 CFR Parts 300-499)

• Subchapter E—Animal Drugs, Feeds, and Related Products (21 CFR Parts 500-599)

• Subchapter F—Biologics (21 CFR Parts 600-699)

• Subchapter G—Cosmetics (21 CFR Parts 700-799)

• Subchapter H—Medical Devices (21 CFR Parts 800-899)

• Subchapter I—Mammography Quality Standards Act (21 CFR Parts 900-999)

• Subchapter J—Radiological Health (21 CFR Parts 1000-1099)

• Subchapter K—Reserved

• Subchapter L—Regulations under Certain Other Acts (21 CFR Parts 1200-1299)

The MPJE candidate should review relevant FDA regulations on the electronic database as described in the introduction to this study guide.

2-4. The Poison Prevention Packaging Act of 1970 and Regulations of the U.S. CPSC

Introduction

The Poison Prevention Packaging Act (PPPA), enacted by Congress in 1970, has as its purpose preventing poisonings in children under 5 years of age. This purpose is achieved through numerous requirements in the act and CPSC regulations.

The PPPA establishes packaging requirements for certain household products. Included among these products are both prescription and nonprescription drug products.

Key Provisions of the PPPA

The MPJE candidate should be familiar with the packaging requirements contained in the PPPA and the regulations of the CPSC. The PPPA is located at Chapter 39A of Title 15 of the United States Code. The MPJE candidate should retrieve and review the sections contained in Chapter 39A as described in the introduction to this study guide.

Regulations of the U.S. CPSC

The CPSC regulations may be found at Part 1700 of Title 16 of the CFR. The MPJE candidate should retrieve and review the sections contained in Part 1700 as described in the explanation to this study guide.

As mentioned earlier, the MPJE candidate is encouraged to review the CPSC publication "Poison Prevention Packaging: A Guide for Healthcare Professionals," available at www.cpsc.gov/CPSCPUB/PUBS/384.pdf.

2-5. Miscellaneous Federal Laws

Omnibus Budget Reconciliation Act of 1990

The Omnibus Budget Reconciliation Act of 1990 (more commonly referred to as OBRA '90) required the states to enact laws to require patient profiling, prospective drug use review, and patient counseling by pharmacies. Although the federal mandate applied only to the provision of pharmacy services to Medicaid beneficiaries, the states extended application of the requirements to all pharmacy patients. The MPJE candidate should review state law on these requirements, and the federal regulations may be found beginning at section 45 CFR 456.700.

Anti-Tampering Act of 1982

This act makes tampering with consumer products a federal offense and was passed as a result of a series of incidents of intentional contamination of Tylenol capsules while held for sale in retail establishments. Regulatory authority resides with the Federal Bureau of Investigation, U.S. Department of Agriculture, and FDA. Regulations for specific types of products may be retrieved (as described in the introduction to this study guide) and reviewed as follows:

• Over-the-counter drug products (21 CFR 211.132)

• Medical devices (21 CFR 800.12)

• Cosmetics (21 CFR 700.25)

Federal Law on Medicinal Use of Alcohol

Under federal law, retailers that sell alcohol are subject to an annual tax, and to handle any type of alcohol, a license from the U.S. Bureau of Alcohol, Tobacco, and Firearms is required. Retailers selling take-home liquors are required to obtain a federal retail liquor dealer's stamp. In a community pharmacy, if the alcohol is sold only for medicinal purposes, a federal medicinal spirits dealer's stamp may be obtained instead of the retail liquor dealer's stamp. Some pharmacies require much larger volumes (usually obtained in 10- or 55-gallon drums) of alcohol, and the alcohol can be purchased tax free. However, the use of tax-free alcohol is subject to a number of federal law restrictions.

• The alcohol must be used for medicinal or scientific purposes or for patient treatment.

• The alcohol must not be sold or loaned to other pharmacies or other practitioners.

• The alcohol, whether in pure form or in combination with other substances, must not be sold to outpatients, with the exception of nonprofit clinics, as long as the patient is not charged.

• The alcohol must be kept in a secure, fire-resistant room.

• A perpetual inventory of the alcohol stock must be maintained.

For additional information, the MPJE candidate can review the sections beginning at 27 CFR 22.1, as described in the explanation to this study guide.

2-6. Questions

1.

Pharmacist Betty Jones decides to open her own community pharmacy. Which of the following DEA forms will she use to apply for a DEA Certificate of Registration for the new pharmacy?

A. DEA Form 106

B. DEA Form 222

C. DEA Form 223

D. DEA Form 224

E. DEA Form 224a

 

2.

You arrive at your community pharmacy one morning and discover that during the night someone broke into the pharmacy and stole several commercial containers of controlled substances. Within how many business day(s) must this theft of controlled substances be reported to the field division office of the DEA in your area?

A. 1

B. 3

C. 7

D. 10

E. 30

 

3.

As the owner of a community pharmacy, you recently employed a staff pharmacist and granted the pharmacist a power of attorney to order controlled substances. In addition to physically signing the DEA order form for schedule II controlled substances, the staff pharmacist completed the steps necessary to obtain authority from the DEA to place electronic orders for all schedules of controlled substances. Today, this pharmacist resigned from your employment. The pharmacist's resignation must be communicated to the DEA Certification Authority within what period?

A. 6 hours

B. 24 hours

C. 3 days

D. 7 days

E. 30 days

 

4.

Which of the following is the federal agency that certifies private practice physicians to prescribe schedule III, IV, or V narcotic controlled substances for detoxification and maintenance treatment of opioid dependency?

A. DEA

B. FDA

C. OIG

D. SAMHSA

E. FTC

 

5.

Frank Wilson, a U.S. citizen, recently traveled outside the United States on business. While outside the country, he became very ill with a gastrointestinal infection and suffered severe nausea, vomiting, diarrhea, and dehydration. A physician in the town where he was located prescribed medications, consisting of an antibiotic and two controlled substances. A local pharmacy dispensed the prescriptions, which were packaged, labeled, and dispensed in much the same manner as if dispensed in the United States. On returning to the United States 2 days after receiving the prescriptions, he proceeded to U.S. Customs, where he was asked if he was bringing any drugs into the country. He responded yes and handed the Customs officer the prescriptions. As to the controlled substance prescriptions, which of the following is true?

A. If either or both of the prescriptions are for a schedule II controlled substance, they will be seized by the Customs officer because federal law prohibits importation of a schedule II controlled substance.

B. Mr. Wilson can legally bring a maximum of 50 dosage units of each of the two controlled substances into the United States.

C. Mr. Wilson can legally bring a maximum total of 50 dosage units combined of the two controlled substances into the United States.

D. Mr. Wilson can bring the antibiotic prescription into the United States but not the prescriptions for controlled substances.

E. Both A and C.

 

6.

A life-supporting or life-sustaining device that requires FDA approval before it can be marketed in interstate commerce in the United States is a

A. class I device.

B. class II device.

C. class III device.

D. class IV device.

E. class V device.

 

7.

For purposes of classifying a drug as an orphan drug, a rare disease or condition is defined as follows: a disease or condition that affects (a) fewer than ______ persons in the United States or (b) more than _____ persons in the United States provided that there is no reasonable expectation that the cost of developing and making the drug available will be recovered.

A. 100,000

B. 200,000

C. 250,000

D. 500,000

E. 1,000,000

 

8.

Which of the following is not one of the recognized "Official Compendia" in the federal Food, Drug, and Cosmetic Act?

A. United States Pharmacopeia

B. Homeopathic Pharmacopeia of the United States

C. National Formulary

D. Approved Drug Products with Therapeutic Equivalence Ratings

 

9.

When a pharmacy orders schedule II controlled substances using the DEA official triplicate order form, which copy (copies) of the form is (are) sent by the pharmacy to the supplier?

A. Copy 1

B. Copy 2

C. Copy 3

D. Copies 1 and 2

E. Copies 2 and 3

 

10.

A quality control manager at Widget Pharmaceuticals has just discovered that a batch sample of a Widget Pharmaceuticals brand of an intravenous solution has tested positive for the presence of a bacterium toxin. If, in fact, the intravenous solution contains a bacterium toxin that is harmful to humans, the solution would be

A. adulterated.

B. misbranded.

 

11.

Pharmacies registered under the federal Controlled Substances Act are required to take a complete inventory of all controlled substances every _____ months.

A. 6

B. 12

C. 18

D. 24

E. 36

 

12.

Dr. Marcia Wilson is a neurologist treating attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD) patients. Among her treatments for these patients, she prescribes Ritalin, Concerta, and Adderall. Her general policy is that patients using these medications must be seen in her office every 3 months for evaluation. Because most of her patients prefer to obtain their prescriptions locally and third-party prescription drug plans will reimburse for a 30-day supply only, Dr. Wilson is forced to issue 3 prescriptions to provide adequate medication between office visits. According to the applicable DEA regulation on issuing multiple prescriptions for a schedule II controlled substance, for how many total days' supply of a schedule II controlled substance may Dr. Wilson issue multiple prescriptions to a patient?

A. 60

B. 90

C. 120

D. 150

E. 180

 

13.

According to the federal Food, Drug, and Cosmetic Act, which of the following may not legally receive and possess prescription drug samples from a manufacturer or authorized distributor of record?

A. Free-standing retail pharmacies

B. Pharmacies located within a hospital or other health care entity, at the written request of a licensed practitioner

C. Osteopathic doctors

D. Dentists

 

14.

One of your regular patients comes into your pharmacy and reports that he developed a dry, hacking cough 2 days ago, and although he has been taking a nonprescription liquid cough suppressant, it has been ineffective in controlling the cough. He says that not too long ago another pharmacy sold him a nonprescription cough suppressant containing codeine that was very effective. He asks if you have such a product, and you reply that you do and agree to sell him the product. Assuming that state law permits selling such a product without a prescription, you may sell not more than 240 cc (8 oz) of a controlled substance containing opium, nor more than 120 cc (4 oz) of any other controlled substance, nor more than 48 dosage units of a controlled substance containing opium, nor more than 24 dosage units of any other controlled substance in any given period of how many hours?

A. 24

B. 36

C. 48

D. 60

E. 72

 

15.

According to the federal Food, Drug and Cosmetic Act, which of the following is exempt from registration with the Food and Drug Administration as a manufacturer?

A. A manufacturer of generic drug products

B. A manufacturer of brand-name drug products

C. A pharmacy compounding a product pursuant to a lawful prescription order

D. A pharmacy compounding a product to supply a physician for that physician to use in dispensing prescription orders

 

16.

"The rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a drug and becomes available at the site of drug action" is the federal Food, Drug, and Cosmetic Act definition of which of the following?

A. Bioavailability

B. Bioequivalency

C. Dissolution

D. Area under the curve

 

17.

Under federal law, the daily sales limit of ephedrine base, pseudoephedrine base, or phenylpropanolamine base is _____ grams per purchaser, regardless of the number of transactions.

A. 1.8

B. 3.6

C. 7.2

D. 9.0

E. 14.4

 

18.

At least how many days before introducing or delivering for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered must the manufacturer or distributor of that supplement, or of the new dietary ingredient, submit to the U.S. Food and Drug Administration information, including any citation to published articles, on which basis the manufacturer or distributor has concluded that the dietary supplement can reasonably be expected to be safe?

A. 30

B. 60

C. 75

D. 90

E. 120

 

19.

With respect to pharmacy compounding of pharmaceutical products, which of the following is not one of the factors considered by the U.S. Food and Drug Administration in determining whether a pharmacy is "compounding" versus "manufacturing" pharmaceutical products?

A. Compounding drugs in anticipation of receiving prescriptions, except in very limited quantities in relation to the amounts of drugs compounded after receiving valid prescriptions

B. Using commercial-scale manufacturing or testing equipment for compounding drug products

C. Offering compounded drugs at wholesale to other state-licensed persons or commercial entities for resale

D. Setting prices for compounded drugs that are far higher than the prices for the same or similar commercially available drugs

E. Compounding drugs that are commercially available in the marketplace or that are essentially copies of commercially available drugs

 

20.

The federal Food, Drug, and Cosmetic Act prohibits the selling, purchasing, or trading of a prescription drug that was purchased by a public or private hospital or other health care entity or donated or supplied at a reduced price to a charitable organization. Which of the following is not one of the exceptions to this prohibition?

A. The purchase or other acquisition by a hospital or other health care entity that is a member of a group-purchasing organization of a drug for its own use from the group-purchasing organization or from other hospitals or health care entities that are members of such an organization

B. A sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or other health care entities that are under common control

C. A sale, purchase, or trade of a drug; an offer to sell, purchase, or trade a drug; or the dispensing of a drug pursuant to a prescription

D. The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization to a nonprofit affiliate of the organization

E. A sale to a community pharmacy for non-emergency dispensing needs

 

21.

A maximum of how many times may a prescription for a schedule III, IV, or V controlled substance may be refilled?

A. 1

B. 2

C. 3

D. 4

E. 5

 

22.

Approximately 30 minutes ago, your community pharmacy received a prescription for a schedule II controlled substance by facsimile transmission. The patient for whom the prescription was issued has just arrived for the prescription. You may dispense the prescription solely on the basis of the facsimile prescription and use the facsimile prescription as the original prescription for purposes of recordkeeping.

A. True

B. False

 

23.

With respect to a prescription for a controlled substance, which of the following may be maintained in an electronic database used for prescription dispensing rather than having to be placed on the actual prescription form maintained in the pharmacy's prescription files?

A. Physician's DEA number

B. Record of refills

C. Patient address

D. The word void or the word transfer required on issuing or receiving, respectively, a transferred prescription for a controlled substance

E. A and B

F. B and C

G. B and D

 

24.

William Wilson has just presented you two empty prescription vials and requests that each be refilled. Both of the prescriptions are for solid, oral dosage formulations. When dispensing the refills (and assuming neither Mr. Wilson nor the prescriber has requested non-child-resistant packaging), you may reuse the prescription vials and closures when dispensing the refills.

A. True

B. False

 

25.

The U.S. Food and Drug Administration regulations regarding medication guides provide that where a medication guide is required for a particular prescription drug product, the medication guide must be provided to the patient on the initial dispensing of the drug but not on any refills thereafter.

A. True

B. False

 

2-7. Answers

1.

D. DEA Form 224 is the application form for a new DEA Certificate of Registration. DEA Form 224a is the renewal application form that DEA mails to registrants approximately 60 days before the expiration of a DEA Certificate of Registration. DEA Form 106 is used to report theft or loss of controlled substances. DEA Form 222 is used to order schedule II controlled substances. DEA Form 223 is the number of the DEA Certificate of Registration that is displayed at the registrant's location. The applicable DEA regulation is 21 CFR 1301.13.

 

2.

A. Although notification is required within 1 business day, completion and submission of DEA Form 106 is not required within 1 business day, but the form should be completed and submitted promptly. The applicable DEA regulation is 21 CFR 1301.76.

 

3.

A. Recognize that before electronic ordering of controlled substances was permitted, notifying the DEA if a pharmacist with a power of attorney resigned or was terminated was not necessary. The power of attorney was useless without physical access to DEA Form 222. But with electronic ordering of controlled substances, a DEA Form 222 is not needed, so notification must be provided if the pharmacist had obtained the authority from DEA to submit electronic orders. The applicable DEA regulation is 21 CFR 1311.45.

 

4.

D. SAMHSA, not the DEA, certifies physicians to prescribe schedule III, IV, and V narcotic controlled substances for detoxification and maintenance treatment of opioid dependency. Prescriptions for the currently approved products Suboxone and Subutex for treatment of opioid dependency must include the physician's DEA number and the physician's "X" number signifying certification to treat opioid dependency. Also, only physicians may be approved to treat opioid dependency. Information about the medication-assisted treatment of opioid dependency is available on the SAMHSA Web site at www.dpt.samhsa.gov. The applicable DEA regulation is 21 CFR 1301.28.

 

5.

C. The limitation associated with the exemption from import and export requirements for personal medical use is a combined 50 dosage units and not 50 dosage units of each controlled substance. The applicable DEA regulation is 21 CFR 1301.26.

 

6.

C. The federal FDCA provides for three classes of medical devices: class I, class II, and class III. Generally class I devices are not subject to premarket approval, and class II devices are subject to performance standards. Class III devices are life-supporting or life-sustaining devices and require premarket approval by FDA. The applicable section of the federal FDCA is 21 USC 360c.

 

7.

B. The applicable section of the federal FDCA is 21 USC 360bb.

 

8.

D. Although the Approved Drug Products with Therapeutic Equivalence Ratings (FDA Orange Book) is an important publication for pharmacy, it is not one of the official compendia. The official compendia are established by the federal FDCA at 21 USC 321.

 

9.

D. The pharmacy keeps copy 3 and sends copies 1 and 2 to the supplier. The applicable DEA regulation is 21 CFR 1305.12.

 

10.

A. The applicable section of the federal FDCA is 21 USC 351.

 

11.

D. Pharmacies are required to conduct a "biennial" inventory of all controlled substances. The applicable DEA regulation is 21 CFR 1304.11.

 

12.

B. The applicable DEA regulation is 21 CFR 1306.12.

 

13.

A. The applicable section of the federal FDCA is 21 USC 353.

 

14.

C. The applicable DEA regulation is 21 CFR 1306.26.

 

15.

C. Pharmacies are exempt from registration, provided that the compounding is "in the regular course of their business of dispensing or selling drugs or devices at retail." The applicable section of the federal FDCA is 21 USC 360.

 

16.

A. The applicable section of the federal FDCA is 21 USC 355.

 

17.

B. The applicable DEA regulation is 21 CFR 1314.20.

 

18.

C. The applicable section of the federal FDCA is 21 USC 3650b.

 

19.

D. The other answer choices are contained in the FDA compliance guide on pharmacy compounding, which is available at www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM118050.pdf.

 

20.

E. The applicable section of the federal FDCA is 21 USC 353.

 

21.

E. As provided in the DEA regulations, "No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than 6 months after the date on which such prescription was issued and no such prescription authorized to be refilled may be refilled more than five times." The applicable DEA regulation is 21 CFR 1306.22.

 

22.

B. Although in some situations a facsimile prescription for a Schedule II controlled substance can be dispensed and can be used as the original prescription for recordkeeping, it cannot be in this situation of an ambulatory patient. The applicable DEA regulation is 21 CFR 1306.11.

 

23.

B. All information required to be placed on a prescription for a controlled substance by either the CSA or the DEA regulations must be placed on the prescription. The only exemption is the record of refills. The applicable DEA regulation is 21 CFR 1306.22.

 

24.

B. As stated by the CPSC in response to whether pharmacists may reuse prescription vials, "As a general rule, no. This prohibition is based on the wear associated with a plastic vial, which could compromise the package's effectiveness. Since such wear or undetected damage with a glass container is negligible, the CPSC staff has indicated that it would have no objection to the reuse of a glass container, provided a new closure is used. This same consideration would be given to any other package type that is not prone to wear." See the CPSC publication "Poison Prevention Packaging: A Guide for Healthcare Professionals" available at www.cpsc.gov/CPSCPUB/PUBS/384.pdf.

 

25.

B. Medication guides must be provided on each dispensing. The applicable FDA regulation is 21 CFR 208.24.