Tips for Handling Controlled Substances
Our bet is that many of you are wondering what we mean when we talk about controlled substances. The rest are probably thinking “What’s the big deal?” Granted, when it comes to dealing with controlled substances, we usually are not discussing serious potential for injury or catastrophic loss. What usually happens is that some of our material or product turns up missing. But you should heed our warning. You do not want to be in that situation, or you will very quickly discover how big of a deal it becomes. State and federal agencies are very serious when it comes to controlled substances. And you should be too.
What exactly are we talking about?
For those who are not familiar with the term controlled substances, it refers to drugs and other substances listed on one of the five schedules published in the Controlled Substance Act, Title 21 Code of Federal Regulations, Part 1308.11 through 1308.15.1 Chemical substances are placed on the schedules based on three primary characteristics: currently accepted medical treatment use in the United States, relative abuse potential, and likelihood of causing dependence when abused. Below are simple definitions of each schedule and a few common examples of each.
Related Webinar: Managing Controlled Substances in the Research Lab
- Schedule I substances have no currently accepted medical use in the U.S., a high potential for abuse, and a lack of accepted safety for use under medical supervision. Examples include heroin, LSD (lysergic acid diethylamide), marijuana (cannabis), and methylenedioxymethamphetamine (Ecstasy).
- According to 21CFR 1308, Schedule II substances are primarily narcotics or stimulants that have a high potential for abuse, which may lead to severe psychological or physical dependence. Narcotic examples include codeine, hydrocodone, morphine, opium and barbitals, and the well-known oxycodone (OxyContin®, Percocet®), and hydromorphone (Dilaudid ®). Examples of stimulants are amphetamines (Dexedrine ®), Adderall®), and methamphetamines (Desoxyn®).
- Schedule III substances have a lower potential for abuse than Schedules I or II substances do, and abuse may lead to moderate or low physical dependence or high psychological dependence. These include products containing not more than 90 milligrams of codeine per dosage unit (Tylenol with Codeine® and buprenorphine (Suboxone®). An anabolic steroid such as Depo-Testosterone® is an example of a non-narcotic Schedule III substance.
- Substances in Schedule IV have a low potential for abuse relative to substances in Schedule III. Examples of Schedule IV substances include alprazolam (Xanax®), carisoprodol (Soma®), and diazepam (Valium®).
- Schedule V substances have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. Examples of Schedule V substances include cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC® and Phenergan with Codeine®).
What do you need to do?
Now that you know what constitutes a controlled substance, what do you need to do?
First, you need to understand that the controlled substance schedules currently list approximately 160 specific substances, and they do not constitute a comprehensive listing of all controlled substances. The schedules describe only basic or parent chemicals and do not list all the salts, isomers and salts of isomers, esters, ethers, and derivatives, which may be controlled substances. If a substance is an analogue and is structurally or pharmacologically substantially similar to or is represented as being similar to a Schedule I or Schedule II substance and is intended for human consumption but not an approved medication in the United States, it can be treated as a Schedule I substance for criminal prosecution.
Second, this article is intended to address the use of controlled substances in research, instruction, and analytical laboratories. It is not our intent to include medical clinical activities, medical veterinary hospitals, or pharmacies, which are governed by federal and state accrediting and regulatory agencies and are subject to review and audit by those agencies.
Related Article: FDA Takes Action Against Pennsylvania Dietary Supplement Maker
Third, and this is the main focus and information you should take away, before you begin using any controlled substance in your lab, you should have all the appropriate licenses and registrations and have a robust program in place for managing these materials.
Staying in control
The heart of proper controlled substance management is a well-thought-out, comprehensive program including vigorous training, record keeping, surveillance, and follow-up. There are many excellent programs readily available, as a quick Internet search will show. No matter which one you choose as your model, ensure that it meets all the requirements. It should cover all the basics mentioned above plus responsibilities of all stakeholders, licensing and registration, purchasing, receiving, storage, and disposal. In addition, pay extra attention to access restrictions, personnel screening, spill procedures, and handling diversion, loss, or theft.2
The Safety Guys’ critical steps and components of a successful controlled substance management plan are briefly discussed here. Most, if not all, states require a license to use controlled substances, and this step is the first hurdle. After you obtain your state license, you need to then register with the federal Drug Enforcement Agency. Excellent step-by-step instructions with explanations are provided on the DEA registration website.3 Pay attention to your specific research requirements for both state and federal applications. The registration is an absolute must, so make sure you get it right. State licenses renew every two years (usually), while the DEA registrations must be renewed annually.
Next, get your on-site paperwork in order, beginning with receiving material through inventory listing and control and ending with use or disposal record keeping. Do not underestimate the importance of safe, secure storage and tightly controlled access. You do not want to go through having to report a loss, theft, or diversion. Trust us.
Finally, make sure your program has well-documented disposal procedures. You must understand that controlled substances are not considered hazardous waste, biological waste, or regulated medical waste. Therefore, they CANNOT be disposed of through your normal biological/ medical/hazardous waste programs. Most solid programs will have requirements to return all unused or expired material to the original manufacturers or distributors. A good backup plan is to set up reverse distributors, specialty contractors knowledgeable and approved for handling controlled substances.
1. Title 21 Code of Federal Regulations, Part 1308-Schedules of Controlled Substances, U.S. Department of Justice, Drug Enforcement Agency, Office of Diversion Control. Springfield, VA 2015. http://www.deadiversion.usdoj.gov/21cfr/cfr/2108cfrt.htm
2. Research Use of Controlled Substances, Cornell University Environmental Health and Safety. New York, NY. February 2013. https://sp.ehs.cornell.edu/lab-research-safety/research-safety/constrolled-substances/Documents/Controlled_Substances_Guidance.pdf
3. DEA Registration, U.S. Department of Justice, Drug Enforcement Agency, Office of Diversion Control. Springfield, VA 2015. http://www.deadiversion.usdoj.gov/drugreg/index.html
Like this article? Click here to subscribe to free newsletters from Lab Manager