1. Federal regulations GreenPharmEdu.org

2. Federal regulations FDAFood and Drugs Administrationwww.fda.gov DEADrug Enforcement Administrationwww.dea.gov USPSU.S. Postal Servicewww.usps.com

3. Federal regulations: FDA (1) FDA supports the Federal Guidelines calling for the responsible disposal of medicines from the home. Almost all medicines can be thrown away in the household trash after mixing them with some unpalatable substance (e.g., coffee grounds) and sealing them in a bag or other container. Drug take-back programs for disposal can be another good way to remove unwanted or expired medicines from the home and reduce the chance that someone may accidentally take the medicine.

4. Federal regulations: FDA (2) There are, however, a few, select medicines (certain controlled substances) that are especially harmful (and possibly deadly in a single dose), if taken accidentally by someone other than the person the medicine was prescribed for. These medicines should not be thrown in the trash, given this method of disposal may still provide an opportunity for a child or pet to accidentally take the medicine. Although FDA endorses drug take-back programs, such programs may be unable to accept drugs that are controlled substances.

5. Federal regulations: FDA (3) Regarding returning controlled substances to drug take back programs or pharmacies, the FDA states that current Federal and some state laws limit who can receive controlled substances for disposal after they are dispensed by the pharmacy to the consumer. This legal limitation could prevent take-back programs or pharmacies from accepting medicines containing controlled substances and, therefore, these programs may be hard to find.

6. Federal regulations: DEA (1) DEA regulations regarding disposal of unused or unwanted medications is intensive and offers very little flexibility. The following describes the procedures for disposal and also mentions drug take back programs. Examples of drug take back programs in various states will be described later in this module.

7. Federal regulations: DEA (2) Disposal of Unused or Unwanted Medications by Ultimate Users: This procedure involves the nonregistrant submitting a letter to the local DEA Special Agent in Charge. The letter must include the name and address of the person; the name and quantity of each controlled substance to be disposed of; how the applicant obtained the controlled substance, if known; and the name, address, and registration number, if known, of the person who possessed he controlled substances prior to the applicant, if known (21 CFR 1307.21(a)(2)). Provided such disposal is permissible under the CSA, the Special Agent in Charge shall authorize and instruct the applicant to dispose of the controlled substance through any of the following methods: Transfer of the substance to a person registered under the CSA and authorized to possess the substance; delivery to an agent of the Administration or to the nearest office of the Administration; by destruction in the presence of an agent of the Administration or other authorized person; or, by such other means as the Special Agent in Charge may determine to ensure that the substance does not become available to unauthorized persons (21 CFR 1307.21(b)). Though this is an option currently available to ultimate users, it is used in extremely limited circumstances.

8. Federal regulations: DEA (3) Another option available for the disposal of unwanted controlled substances dispensed to ultimate users is through take-back programs that comply with applicable Federal and state law. Take-back programs are organized collection events designed to reduce the amount of unwanted or unused pharmaceuticals that may pose a risk to public health and safety, may be accessible to diversion, or that otherwise may be disposed of in a manner that does not comply with State or Federal laws or regulations. As previously stated, the distribution of a controlled substance by an ultimate user for the purpose of disposal is a scenario not contemplated by the CSA and its closed system of distribution. However, as indicated above, ultimate users, and other DEA nonregistrants, in possession of controlled substances may dispose of those substances by receiving permission from the local DEA Special Agent in Charge, provided such disposal takes place in a manner consistent with the structure of the CSA.

9. Federal regulations: DEA (4) In the absence of regulations expressly addressing the disposal of controlled substances dispensed to ultimate users, DEA has recently granted temporary permission to law enforcement agencies who have requested authorization to accept for disposal controlled substances that have been dispensed to ultimate users. In granting such temporary authorization, DEA has imposed certain conditions to ensure that the controlled substances do not become available to unauthorized persons, consistent with 21 CFR 1307.21, and to promote consistency with the structure of the CSA. Thus, the only take-back programs for which DEA has recently granted temporary allowances are those in which law enforcement officials directly receive the controlled substances from the ultimate users. Recognizing that there might be additional appropriate methods of allowing for the disposal of controlled substances dispensed to ultimate users, DEA is seeking information to provide more accessible ways to safely and responsibly dispose of dispensed controlled substances in a manner consistent with the CSA.

10. Federal regulations:USPS 12.12 Drugs (1) 12.12.5 Return of Prescription Drugs Mailers may use merchandise return service to return prescription drugs for purposes of drug recalls; voluntary manufacturer withdrawals; and dispensing errors such as incorrect drug, dosage, or strength, as permitted by 21 CFR 1307.12 or other applicable law. The mailpiece must be addressed to the manufacturer or its registered agent. Manufacturers or their registered agents must furnish mailing containers to their customers for the purpose of mailing back the identified drugs. Manufacturers or their registered agents must use merchandise return service (see 507.11.0) with First-Class Mail or Priority Mail for these mailpieces. Manufacturers or their agents continue to be responsible for maintaining records in compliance with any regulation of the Drug Enforcement Administration and/or the Food and Drug Administration.

11. Federal regulations:USPS 12.12 Drugs (2) 12.12.6 Mailing Standards If distribution of a controlled substance is lawful under 21 USC 801, et seq., and any implementing regulation in 21 CFR 1300, et seq., the USPS considers such distribution by mail to constitute the mailing of matter not outwardly or of its own force dangerous or injurious to a person's life or health and accordingly mailable, subject to these standards: a. The inner container of any package containing controlled substances is marked and sealed under the applicable provisions of the Controlled Substances Act (21 USC 801, et seq., and any implementing regulation in 21 CFR 1300, et seq.) and placed in a plain outer mailing container or securely overwrapped in plain paper. b. If the mailing includes prescription drugs containing controlled substances, the inner container is also labeled to show the prescription number and the name and address of the pharmacy, practitioner, or other person dispensing the prescription. c. The outer mailing wrapper or container is free of markings that indicate the nature of the content.