OUTLINE
Legal Jurisdiction for Controlled Substances
Schedules for Controlled Substances
Requirements for Prescription Orders for Controlled Substances
Requirements for Nonprescription Sales of Controlled Substances
Record Keeping for Controlled Substances
Labeling of Prescriptions for Controlled Substances
I. LEGAL JURISDICTION FOR CONTROLLED SUBSTANCES
Controlled substances are regulated by both federal and state laws.
A. Federal laws
1. The original U. S. federal law regulating addictive substances was the Harrison Narcotics Act of 1914. Because, at that time, the distribution and sale of narcotics was controlled through the use of a tax on narcotic drug products, this law was enforced by the Bureau of Internal Revenue in the Department of the Treasury. In 1968, through an administrative reorganization, enforcement was transferred to the newly created Bureau of Narcotics and Dangerous Drugs (BNDD) in the Department of Justice (1,2).
2. By 1970, in addition to the Harrison Narcotics Act, there were many diverse federal laws regulating drugs considered to be addictive and/or dangerous. As a result, a comprehensive new law, the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 (Public Law 91-513), was passed. The Controlled Substances Act of 1970 is Title II of this law; it went into effect on May 1, 1971. It remains the primary federal law regulating all aspects, from manufacturing through distribution to dispensing, administration and use, of drugs that have the potential for abuse or psychological or physical dependences (2,3). The law can be found in Chapter 13 of Title 21 of the United States Code (USC).
Note: The USC contains the general and permanent laws of the United States. It is divided into approximately 50 broad subject areas with title names and numbers. For example, Title 2 deals with Congress, Title 12 with Banks and Banking, Title 29 with Labor, and Title 21 with Food and Drugs. The general title subjects are further subdivided into chapters so that Title 21 has Chapter 9, which contains the Federal Food, Drug, and Cosmetic Act, whereas the laws in Chapter 13 are those that deal with Drug Abuse and Prevention. Title 21, Chapter 13 contains the provisions of the Controlled Substances Act (CSA) and its amendments. The latest version of the text of the USC can be accessed on the Internet through the U.S. Government Printing Office Web site: www.access.gpo.gov. This site has a selection for access to government information that provides a list with links to various important public documents, such as the USC. You can purchase printed copies of the documents through this site, but it also provides selected documents online in text and/or pdf formats.
3. Since 1973, the CSA has been under the jurisdiction of the Drug Enforcement Administration (DEA) in the Department of Justice. The DEA was created in 1973 by merging the BNDD (in the Department of Justice) with the Drug Investigation arm of the U.S. Customs Service (in the Department of the Treasury). This was to be a “superagency” that would coordinate all federal efforts related to narcotic and dangerous drug enforcement, including domestic drug abuse, diversion, and international smuggling of illicit drugs into the United States. The DEA was put in the Department of Justice so it would have ready access to the robust investigative resources of the Federal Bureau of Investigation (FBI) (2).
4. The DEA regulations that spell out the provisions and applications of the CSA (21 USC § 801 and following) can be found in Title 21 of the Code of Federal Regulations (CFR). As with the USC, the latest revision the CFR can be accessed on the Internet through the U.S. Government Printing Office Web site given earlier. The applicable information can be found in 21 CFR §1300 and following. In accessing the text, you will be required to request each part of the regulation separately (e.g., 21CFR1300, 21CFR1301, 21CFR1302, and so on), but the first section, 1300, contains a useful table of contents.
5. In the 1990s, it was recognized that there was a growing problem nationally with drug abuse of the Schedule II drug methamphetamine (also known as “speed”or “crank”). In addition to being a less expensive alternative to cocaine, methamphetamine was easier to obtain; the drug can be synthesized in “home labs” (often referred to as clandestine labs) using readily available precursors, such as ephedrine, pseudoephedrine, and phenylpropanolamine, which at that time were noncontrolled, nonprescription drugs used legitimately for coughs, colds, and congestion. As a result, in October 1996, the U.S. Congress passed the Comprehensive Methamphetamine Control Act of 1996. The purpose of this law was to restrict access to the precursor drugs and the solvents and chemicals used to make methamphetamine (2). This effort was further strengthened when the Combat Methamphetamine Epidemic Act of 2005 (Title VII of the USA PATRIOT Improvement and Reauthorization Act of 2005, Public Law 109-177) was signed into law in March 2006 (4).
B. State laws
1. All states have laws and regulations that are similar to those described previously, but states may have provisions that are stricter than those in the federal acts.
2. Pharmacists must follow the most stringent regulations, federal or state, which apply for their practice site.
C. The information given in this chapter is a brief synopsis of the federal regulations of controlled substances that affect general dispensing activities of pharmacists. Other areas of regulation for controlled substances, such as security requirements, inventory requirements, disposal of controlled substances, and narcotic treatment programs, are beyond the scope of this text.
1. For more complete information on this subject, consult the applicable sections of the Code of Federal Regulations (21 CFR §1300 and following), the USC (21 USC. § 801 and following), current state pharmacy practice acts, reference books on pharmacy law, and Internet Web sites on the subject. Because the laws and regulations are frequently changed and updated, it is important to check current laws and regulations.
2. The DEA Diversion Control Program maintains an excellent resource for pharmacists, pharmacy students, and pharmacy technicians to assist them in understanding and complying with the provisions of the CSA. Called the Pharmacist’s Manual, it is available in print or on the Internet at http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/index.htm, Accessed December 2007. The Pharmacist’s Manual explains the applicable regulations in very understandable language and includes tables that give easy comparisons for requirements for the various classes.
II. DEFINITIONS
A. In understanding the regulations regarding controlled substances, it is useful to have the definitions of certain terms as specified by 21 USC § 802 and 21 CFR § 1300. The definitions that follow give the basic sense of these terms as found in these laws and regulations; in most cases, the definitions are paraphrased to simplify some of the legal language and to eliminate some of the redundancy. Some definitions are included here because their use in the CSA differs from the usual meaning of the terms.
B. Definitions
1. Controlled substances are drugs or other substances or immediate precursors that are specified in schedules I through V of the CSA (5). They are substances that have been deemed to have the potential for abuse or psychological or physical dependence and include narcotics, depressants, stimulants, anabolic steroids, and hallucinogens. Descriptions of Schedules I through V with examples of drugs in each schedule are given in section IV of this chapter. A complete list of drugs and substances, by schedule, is published in 21 CFR § 1308.
2. Narcotics include opium, opiates, coca leaves, cocaine, ecgonine, and any of their salts, derivatives and isomers, and compounds, mixtures, and preparations of these substances (5). CFR §1300.1 gives a long list of narcotics drugs, including codeine, morphine, hydrocodone, hydromorphone, and oxycodone (6).
3. Depressant or stimulant substances are barbiturates, amphetamines, lysergic acid, and any of their salts, derivatives, and isomers plus any drugs or substances designated by the Attorney General to have the potential for abuse because of their depressant, stimulant, or hallucinogenic effect (5). Examples of drugs that have been added to the original list by the Attorney General include the benzodiazepines, such as alprazolam and diazepam, the depressants methaqualone and gamma hydroxybutyric acid, and the stimulant drug methylphenidate.
4. Marihuana includes all parts of the Cannabis sativa plant, including the seeds and extracted resins and all compounds, salts, derivatives, mixtures, and preparations of the plant (5).
5. Anabolic steroids are drugs or hormonal substances chemically and pharmacologically related to testosterone (6). 21 CFR § 1300.1 gives approximately two pages of listed substances in this group.
6. List I Chemicals are drugs or chemicals specified by the Attorney General as precursor chemicals that are used in the illegal manufacture of controlled substances. They include the drugs ephedrine, pseudoephedrine, and phenylpropanolamine, which are precursors used in the synthesis of methamphetamine; and ergotamine and ergonovine, which can be used to make lysergic acid diethylamide and similar hallucinogens (5).
7. List II Chemicals are chemicals designated by the Attorney General that are used in the illegal manufacture of controlled substances. They include solvents, such as acetone, ethyl ether, and toluene; and oxidizing and reducing agents, such as potassium permanganate and iodine (5).
8. Scheduled listed chemical products are products that (i) contain ephedrine, pseudoephedrine, or phenylpropanolamine and (ii) have been approved for nonprescription (over-the-counter) distribution by the Federal Food, Drug, and Cosmetic Act (4).
9. In this Act, the term person is not limited to an individual but includes businesses, corporations, government agencies, associations, and other legal entities (6).
10. An individual practitioner is a physician, dentist, veterinarian, or other individual who is registered or licensed by the appropriate jurisdiction (usually the state) to dispense controlled substances in the course of his or her professional practice. It does not include pharmacists, pharmacies, or institutional practitioners (6).
11. An institutional practitioner is a hospital or other entity (but not an individual) that is registered or licensed by the appropriate jurisdiction to dispense controlled substances. It does not include pharmacies (6). It is interesting that CFR subdivides practitioners as shown here, whereas the USC just defines the word “practitioner” and has a broader definition that includes pharmacies and also scientists who use controlled substances in research and teaching (5).
12. A mid-level practitioner is an individual other than a physician, dentist, veterinarian, or podiatrist who is licensed by their jurisdiction (e.g., state government) to dispense controlled substances. Examples include nurse practitioners, nurse midwives, nurse anesthetists, and physician assistants (6). Specific privileges and restrictions on prescribing by mid-level practitioners are defined by each state.
13. The term dispenser includes practitioners (as defined earlier) and pharmacies and pharmacists who dispense controlled substances (6).
14. The term pharmacist has the usual meaning, but it also includes pharmacy interns working under the supervision of a pharmacist (6).
III. DEA REGISTRATION
A. The CSA uses the medium of registration to regulate all aspects of narcotics, stimulants, depressants, hallucinogenic drugs, anabolic steroids, and chemicals used to illegally manufacture controlled substances (3). To aid government officials in administering and enforcing the controlled substance regulations, all importers and exporters, manufacturers, distributors, researchers, practitioners, pharmacies, hospitals, and teaching and research institutions that handle controlled substances must register with the DEA. In fact, 21 CFR § 1301.13 lists ten different classes of registrants.
B. Upon registration, these parties are issued DEA registration numbers.
1. Registrants must record their DEA numbers on all documents that they use for the transfer or distribution of controlled substances up to the ultimate consumer.
2. DEA numbers are unique, nine-character numbers that are computer-generated to contain check digits that help pharmacists identify invalid registration numbers and fraudulent prescription orders for controlled substances.
C. Practitioners, hospitals, clinics, retail pharmacies, and teaching institutions are included in the registration class “Dispensing or Instructing.”This class uses DEA application form 224 for initial registration and 224a for renewal, which is required every 36 months (7).
D. Prescribers of controlled substances
1. Individuals who are registered with the DEA to prescribe controlled substances include the individual practitioners and mid-level practitioners as described in the section above on definitions.
2. The DEA registration number of the prescriber must appear on any outpatient prescription order for a controlled substance.
3. Many dispensing software packages automatically check for invalid registration numbers when new prescription orders for controlled substances are entered into the computer. The pharmacist or pharmacy technician may also manually check for an invalid DEA registration number on a prescription order by using the following steps.
1. The first digit should be a letter: A, B, or F for prescribers and dispensers, M for midlevel practitioners, and P for distributors.
2. The second digit is usually a letter, specifically, the first letter of the registrant’s last name. In the foregoing case, if the prescriber’s last name is Jones, the second letter of a valid DEA number would be J, so the example DEA number would be invalid. If the registrant is a business with a name that starts with a number, such as “5th Avenue Pharmacy,” the second digit should be the number “9.”
3. The third through the eighth positions of the DEA number contain numbers that are used to calculate the number in the ninth position, the check digit.
a. Add the first, third, and fifth digits: 5 + 2 + 8 = 15.
b. Add the second, fourth, and sixth digits and multiply this sum by 2: 4 + 6 + 1 = 11 × 2 = 22.
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