Dispensing Controlled Substance Prescriptions: A Legal Review for Practicing Pharmacists
Walter L. Fitzgerald, Jr, MS, JD, DPh*
Passed in 1970, the Controlled Substances Act (CSA) is considered the basis for modern regulation pertaining to the sale and use of potentially abused drugs and is actually a culmination of several historical efforts to place federal regulations on drugs.1,2 One of the earliest efforts was the 1914 Harrison Narcotics Act, which focused almost exclusively on opiates by requiring only distributors of narcotics (opiates and cocaine) to register. Years later, after the 1938 passage of the Food, Drug, and Cosmetic Act, the US Food and Drug Administration (FDA) began attempting to limit the distribution of certain non-narcotic drugs of abuse, including barbiturates and amphetamines. The need for more comprehensive drug control legislation became increasingly clear in the 1960s, when it was determined that the FDA lacked many of the tools necessary to regulate drug distribution and was limited in its range of potential action in cases of illicit drug use.1 The perceived solution came in 1965, with the passage of the Drug Abuse Control Amendments (DACA), which exerted more stringent and broader drug control over barbiturates, amphetamines, central nervous system stimulants, and any drug with a “potential for abuse due to depressant, stimulatory, or hallucinatory effect.”1 Anticipating that evaluation of new substances would be an ongoing necessity, DACA created the Bureau of Drug Abuse Control (BDAC), which regulated the process of adding drugs to the controlled list and enforced regulations at the time. The ultimate shortcomings (eg, absence of data collection on non-narcotic drugs and inadequate abuse reporting) of both DACA and BDAC appeared to serve as the impetus for the CSA, which was a more uniform regulation system that placed controlled substances into 5 schedules (Table) based on medical utility and potential for abuse.1
Table. Schedules of Controlled Substances
Schedule I Substances
• Substances in this schedule have a high abuse potential and no accepted medical use in the United States. This is the only schedule that includes drugs that are not available for prescribing, dispensing, or administering. DEA does allow for research involving Schedule I substances. This requires a separate registration as a researcher.
• Examples include heroin, propiram, LSD, marijuana, and methaqualone.
Schedule II Substances
• Substances in Schedule II have a high abuse potential with severe psychological or physical dependence liability, have an accepted medical use in the United States, and are available for practitioners to prescribe, dispense, and administer.
• Examples include morphine, hydromorphone, methadone, amphetamine, cocaine, and secobarbital.
Schedule III Substances
• Substances in this schedule have an abuse potential that is less than those in Schedule II, but more than Schedule IV substances.
• Examples include products containing <15 mg of hydrocodone per dosage unit, products containing no more than 90 mg of codeine per dosage unit, anabolic steroids, and suppository dosage forms containing certain barbiturates.
Schedule IV Substances
• Substances in this schedule have an abuse potential less than those listed in Schedule III and more than substances in Schedule V.
• Examples include propoxyphene, benzodiazepines, barbital, phenobarbital, chloral hydrate, phentermine, and sibutramine.
Schedule V Substances
• Substances in this schedule have an abuse potential less than those listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotic and stimulant drugs generally for antitussive, antidiarrheal, and analgesic purposes.
• Examples include cough preparations containing no more than 200 mg of codeine per 100 mL or per 100 g.
DEA = US Drug Enforcement Administration; LSD = lysergic acid diethylamide
The CSA was designed to improve the administration and regulation of “the manufacture, import/export, distribution and dispensing of controlled substances by providing a closed system for distribution.” Under this closed system, “a controlled substance can be traced from the time it is manufactured to the time it is dispensed to the ultimate user.”2 Subsequent amendments to the CSA (the Chemical Diversion and Trafficking Act of 1988, the Domestic Chemical Diversion Control Act of 1993, and the Comprehensive Methamphetamine Control Act of 1996) led to further regulations on listed chemicals and scheduled listed chemical products, which include agents (eg, pseudoephedrine, ephedrine, and phenylpropanolamine) commonly used to illegally manufacture drugs such as amphetamine and methamphetamine. Because significant quantities of drug products containing these chemicals may be sought from retail outlets for use in clandestine manufacturing operations, their distribution is now subject to certain registration, recordkeeping, and reporting requirements.2
Since the passage of the CSA, which is a federal law, individual states have enacted local controlled substance laws that may, in some cases, be more stringent than the CSA. For example, although the CSA permits over-the-counter sale of certain Schedule V antitussive preparations, some states require a prescription for these same preparations. When faced with this duality of laws, pharmacists must abide by the more stringent of the 2 laws. Numerous agencies serve to support the CSA, with the US Drug Enforcement Administration (DEA) being the lead agency within the federal government responsible for enforcement of the CSA and regulation of controlled substances. Established shortly after the passage of the CSA, the DEA cooperates with state authorities, federal agencies, private industry, and foreign governments to prevent the diversion of controlled substances for illicit purposes.2 Another closely involved agency is the FDA, which is responsible for assessing a drug product’s potential for abuse and misuse during the approval process.3 If a potential for abuse exists, the product’s sponsor is required to provide the FDA with all data pertinent to abuse of the drug, a proposal for scheduling under the CSA, and data on overdoses. The CSA requires the Secretary of Health and Human Services (HHS) to notify the Attorney General through the DEA, if a “new drug application is submitted for any drug having a stimulant, depressant, or hallucinogenic effect on the central nervous system.”3 HHS has delegated this function to the FDA, which assesses preclinical, clinical, and epidemiologic data to determine whether a drug under review requires abuse liability studies, scheduling under the CSA, or a risk minimization action plan designed to reduce abuse, overdose, or diversion. In an effort to minimize illegal sale, diversion, and use of prescription drugs, the FDA collaborates with other government agencies and professional groups, such as the Substance Abuse and Mental Health Services Administration (SAMHSA), the National Institute on Drug Abuse, the Office of National Drug Control Policy, the Centers for Disease Control and Prevention, and the American Medical Association.3
In an effort to educate community pharmacists on the latest legal issues pertaining to controlled substances, this issue of University of Tennessee Advanced Studies in Pharmacy provides a focused
review of the federal laws governing pharmacy distribution of controlled substances. Alan R. Spies, RPh, JD, MBA, PhD, provides a summation of the major DEA requirements in regard to processing and dispensing Schedule II through V prescriptions and a discussion on assessing legitimate medical purpose of a scheduled prescription. Dr Spies, an Assistant Professor of Pharmacy Administration at Southwestern Oklahoma State University, College of Pharmacy, has also contributed a case study examining the opioid-related overdose fatality of a 46-year-old patient and the legal ramifications that followed.
Walter L. Fitzgerald, Jr, MS, JD, DPh, offers a discussion on the use buprenorphine and buprenorphine-naloxone for opioid-dependence treatment, with a focus on legal requirements surrounding distribution of these products. Dr Fitzgerald, Dean of Pharmacy Education Program Development at South College, presents a therapeutic profile of buprenorphine-based therapy and explores requirements from the SAMHSA for prescribing and dispensing these products. In addition, a checklist containing the major aspects of the federal regulations discussed throughout this issue is included.
More than ever before, pharmacists are being given non-dispensing responsibilities, encompassing clinical, managerial, and legal skills. As stated in Dr Spies’ case study, the court system has expanded pharmacists’ liability, acknowledging that a pharmacist has a greater responsibility to the patient than simply “counting, pouring, licking, and sticking.” Along with that responsibility comes the obligation to know the law.
1. Spillane J. Debating the controlled substances act. Drug Alcohol Depend. 2004;76:17-29.
2. Pharmacist’s Manual: An Informative Outline of the Controlled Substances Act of 1970. 8th ed. Washington, DC: Drug Enforcement Administration; 2004. Available at: http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/2pharm_manual.pdf. Accessed September 7, 2008.
3. Meyer RJ. FDA’s Role in Preventing Prescription Drug Abuse. US Department of Health and Human Services Web site. Available at: http://www.os.dhhs.gov/asl/testify/t050913.html. Accessed September 7, 2008.
*Dean, Pharmacy Education Program Development, South College, Knoxville, Tennessee.
Address correspondence to: Walter L. Fitzgerald, Jr, MS, JD, DPh, Dean, Pharmacy Education Program Development, South College, 3904 Lonas Drive, Knoxville, TN 37909.
The content in this monograph was developed with the assistance of a staff medical writer. Each author had
final approval of his article and all its contents.