How do you dispose of a controlled substance?
Rx Legal Q&A
How do you dispose of a controlled substance?
By Ken Baker, R.Ph., J.D.
If you have a practice-related legal question, please e-mail it to firstname.lastname@example.org.
Q: Last week an R.N. came to me and handed me one tablet of OxyContin 20 mg. She said she found it in a drawer in a patient's room. It had been sitting there for 17 months. What is the legal solution to this issue? Should I put the drug back in stock or destroy it in the toilet or sink?
A: Because you cannot verify the storage conditions or even where the tablet came from, you cannot return it to stock. You also cannot "destroy it in the toilet or sink." Disposal of a Schedule II drug, like all controlled substances, is regulated by federal law. You probably wish this tablet had never come into your possession, but now that it has, you must treat it like every other controlled substance in your pharmacy.
While the manner in which this drug came to you is somewhat unusual, the disposal problem is no different from that which every pharmacy faces from time to time. If a drug is expired or is returned by a deceased patient's relatives or for some other reason cannot be used for regular stock, it must be handled in the manner prescribed by law.
The Food and Drug Act (U.S.C. Title 21) provides at least a part of your answer. Section 1307.21 is entitled "Procedure for disposing of controlled substances." Paragraph [a] reads:
[a] Any person in possession of any controlled substance and desiring or required to dispose of such substance may request assistance from the Special Agent in Charge of the Administration in the area in which the person is located for authority and instructions to dispose of such substance.
Since you are a "registrant," you must submit a special form to the Drug Enforcement Administration (in triplicate, of course). This special form (DEA Form 41) lists "the controlled substance or substances which he/she desires to dispose of." After the form is filled out, it is submitted "to the Special Agent in Charge in his/her area." The statute is specific about what information is required.
When DEA receives your form, it will give you one of several options, which may include destroying it in front of a DEA agent. There are other options for the DEA. Paragraph [c] states:
[c] In the event that a registrant is required regularly to dispose of controlled substances, the Special Agent in Charge may authorize the registrant to dispose of such substances, in accordance with paragraph (b) [setting forth the methods of disposal] of this section, without prior approval of the Administration in each instance, on the condition that the registrant keep records of such disposals and file periodic reports with the Special Agent in Charge summarizing the disposals made by the registrant. In granting such authority, the Special Agent in Charge may place such conditions as he deems proper on the disposal of controlled substances, including the method of disposal and the frequency and detail of reports.
Of course, the answer is not quite that simple. You must also consider state laws and regulations. Paragraph [d] says the state laws are not preempted by the federal law, so you have to consider both.
(d) This section shall not be construed as affecting or altering in any way the disposal of controlled substances through procedures provided in laws and regulations adopted by any State.
The second step, then, is to call DEA. This is a second step because your first call should be to your state board of pharmacy, which will often have its own procedures and works closely with DEA in these matters. In reality, you will probably find the procedure "almost painless."
The AUTHOR is a VP and general counsel at Pharmacists Mutual Insurance Co.
Disclaimer: This article discusses general principles of law and risk management. It is not intended as legal advice but is designed to promote discussion. Pharmacists should consult their own attorney for specific advice. Pharmacists should be familiar with the policies and procedures of their employers and with the laws in their state and act accordingly.
Ken Baker. How do you dispose of a controlled substance? Drug Topics Sep. 15, 2003;147:58.
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