Controlled Substance Disposal

Controlled Substance Disposal Services

Disposal of Controlled Substances is a highly regulated and rigorous process.  San Diego Medical Waste Services, LLC strives to help our generators of medical waste and controlled substances understand what is required of them as well as help them develop a process that suits their needs and keeps them in compliance.  Due to the ambiguity in this area, please refer to the Controlled Substances Act (CSA), 21 USC 801-890, and the DEA regulations, Title (21 CFR 1317) for the Drug Enforcement Administration (DEA) Code of Federal Regulations.

This pages intent is to summarize and explain the basic requirements for disposing of controlled substances.

  • Today, more than 6 million Americans are abusing prescription drugs—that is more than the number of Americans abusing cocaine, heroin, hallucinogens, and inhalants, combined.

  • Researchers from the Centers for Disease Control and Prevention report that opioid prescription painkillers now cause more drug overdose deaths than cocaine and heroin combined.

  • Today more new drug users have begun abusing pain relievers (2.4 million) than marijuana (2.1 million) or cocaine (1.0 million).

3 Steps for properly disposing of controlled substance

  1. Determine your DEA Status.

    • DEA Registrant

    • Ultimate User and Other Non-Registrants

  2. Determine the DEA Classification (I, II, III, IV, V) for each of the controlled substance that you are disposing of.

    • DEA Schedule I Substances

      • Substances in this schedule have no currently accepted medical use in treatment in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.

      • Some examples of substances listed in Schedule I are: heroin; lysergic acid diethylamide (LSD); marijuana (cannabis); peyote; methaqualone; and methylene-dimethoxymethamphetamine (“ecstasy”).

    • DEA Schedule II Substances

      • Substances in this schedule have a high potential for abuse with severe psychological or physical dependence.

      • Examples of single entity Schedule II narcotics include morphine, codeine, opium, cocaine, amobarbital, glutethimide, and pentobarbital.

    • DEA Schedule III Substances

      • Substances in this schedule have a potential for abuse less than substances in Schedules I or II.

      • Examples of Schedule III narcotics include combination products containing less than 15 milligrams of hydrocodone per dosage unit (i.e., Vicodin®) and products containing not more than 90 milligrams of codeine per dosage unit (i.e., Tylenol with codeine®).

    • DEA Schedule IV Substances

      • Substances in this schedule have a lower potential for abuse relative to substances in Schedule III.

      • Examples of a Schedule IV narcotics include propoxyphene (Darvon® and Darvocet-N 100®). Other Schedule IV substances include alprazolam (Xanax®), clonazepam (Klonopin®), clorazepate (Tranxene®), diazepam (Valium®), lorazepam (Ativan®), midazolam (Versed®), temazepam (Restoril®), and triazolam (Halcion®).

    • DEA Schedule V Substances

      • Substances in this schedule have a lower potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotic and stimulant drugs. These are generally used for antitussive, antidiarrheal and analgesic purposes.

      • Examples include cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC®, and Phenergan with Codeine®).

 

DEA Registrant Disposal

In accordance with the Drug Enforcement Administration Practitioner’s Manual (2006 Edition).

  • A practitioner may dispose of out-of-date, damaged, or otherwise unusable or unwanted controlled substances, including samples, by transferring them to a registrant who is authorized to receive such materials. These registrants are referred to as “Reverse Distributors.” The practitioner should contact the local DEA field office (See Appendix E) for a list of authorized Reverse Distributors. Schedule I and II controlled substances should be transferred via the DEA Form 222, while Schedule III–V compounds may be transferred via invoice. The practitioner should maintain copies of the records documenting the transfer and disposal of controlled substances for a period of two years.

§1317.05 DEA Registrant Disposal
  1. Practitioner inventory. Any registered practitioner in lawful possession of a controlled substance in its inventory that desires to dispose of that substance shall do so in one of the following ways.

    • Promptly destroy that controlled substance in accordance with subpart C of this part using an on-site method of destruction

    • Promptly deliver that controlled substance to a reverse distributor's registered location by common or contract carrier pick-up or by reverse distributor pick-up at the registrant's registered location

    • For the purpose of return or recall, promptly deliver that controlled substance by common or contract carrier pick-up or pick-up by other registrants at the registrant's registered location to: The registered person from whom it was obtained, the registered manufacturer of the substance, or another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer's behalf

    • Request assistance from the Special Agent in Charge of the Administration in the area in which the practitioner is located.

      • The request shall be made by submitting one copy of the DEA Form 41 to the Special Agent in Charge in the practitioner's area. The DEA Form 41 shall list the controlled substance or substances which the registrant desires to dispose.

      • The Special Agent in Charge shall instruct the registrant to dispose of the controlled substance in one of the following manners:

        • By transfer to a registrant authorized to transport or destroy the substance;

        • By delivery to an agent of the Administration or to the nearest office of the Administration; or

        • By destruction in the presence of an agent of the Administration or other authorized person.

      • In the event that a practitioner is required regularly to dispose of controlled substances, the Special Agent in Charge may authorize the practitioner to dispose of such substances, in accordance with subparagraph (a)(4) of this section, without prior application in each instance, on the condition that the practitioner keep records of such disposals and file periodic reports with the Special Agent in Charge summarizing the disposals. The Special Agent in Charge may place such conditions as he/she deems proper on practitioner procedures regarding the disposal of controlled substances.

  2. Non-practitioner inventory. Any registrant that is a non-practitioner in lawful possession of a controlled substance in its inventory that desires to dispose of that substance shall do so in one of the following ways:

    • Promptly destroy that controlled substance in accordance with subpart C of this part using an on-site method of destruction;

    • Promptly deliver that controlled substance to a reverse distributor's registered location by common or contract carrier or by reverse distributor pick-up at the registrant's registered location

    • For the purpose of return or recall, promptly deliver that controlled substance by common or contract carrier or pick-up at the registrant's registered location to: The registered person from whom it was obtained, the registered manufacturer of the substance, or another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer's behalf; or

    • Promptly transport that controlled substance by its own means to the registered location of a reverse distributor, the location of destruction, or the registered location of any person authorized to receive that controlled substance for the purpose of return or recall as described in paragraph (b)(3) of this section.

      • If a non-practitioner transports controlled substances by its own means to an unregistered location for destruction, the non-practitioner shall do so in accordance with the procedures set forth at §1317.95(c).

      • If a non-practitioner transports controlled substances by its own means to a registered location for any authorized purpose, transportation shall be directly to the authorized registered location and two employees of the transporting non-practitioner shall accompany the controlled substances to the registered destination location. Directly transported means the substances shall be constantly moving towards their final location and unnecessary or unrelated stops and stops of an extended duration shall not occur.

  3. Collected controlled substances. Any collector in lawful possession of a controlled substance acquired by collection from an ultimate user or other authorized non-registrant person shall dispose of that substance in the following ways

    • Mail-back program. Upon receipt of a sealed mail-back package, the collector shall promptly:

      • Destroy the package in accordance with subpart C of this part using an on-site method of destruction; or

      • Securely store the package and its contents at the collector's registered location in a manner consistent with §1301.75(c) of this chapter (for practitioners), or in a manner consistent with the security requirements for Schedule II controlled substances (for non-practitioners) until prompt on-site destruction can occur.

    • Collection receptacles. Upon removal from the permanent outer container, the collector shall seal it and promptly:

      • Destroy the sealed inner liner and its contents;

      • Securely store the sealed inner liner and its contents at the collector's registered location in a manner consistent with §1301.75(c) of this chapter (for practitioners), or in a manner consistent with §1301.72(a) of this chapter (for non-practitioners) until prompt destruction can occur; or

      • Securely store the sealed inner liner and its contents at a long-term care facility in accordance with §1317.80(d).

      • Practitioner methods of destruction. Collectors that are practitioners (i.e., retail pharmacies and hospitals/clinics) shall dispose of sealed inner liners and their contents by utilizing any method in paragraph (a)(1), (a)(2), or (a)(4) of this section, or by delivering sealed inner liners and their contents to a distributor's registered location by common or contract carrier pick-up or by distributor pick-up at the collector's authorized collection location.

      • Non-practitioner methods of destruction. Collectors that are non-practitioners (i.e., manufacturers, distributors, narcotic treatment programs, and reverse distributors) shall dispose of sealed inner liners and their contents by utilizing any method in paragraph (b)(1), (b)(2), or (b)(4) of this section, or by delivering sealed inner liners and their contents to a distributor's registered location by common or contract carrier or by distributor pick-up at the collector's authorized collection location for destruction. Freight forwarding facilities may not be utilized to transfer sealed inner liners and their contents.

3. Disposal of Controlled Substances 

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