Health Law Update

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The U.S. Drug Enforcement Administration (DEA) recently issued a <a href="http://www.gpo.gov/fdsys/pkg/FR-2014-09-09/pdf/2014-20926.pdf">Final Rule</a> expanding the facilities that can collect unused prescription drugs to now include retail pharmacies, hospitals and pharmaceutical manufacturers, as well as other specified entities. The Final Rule allows these entities to institute prescription drug take-back programs where patients can turn over unused pharmaceuticals either by mail or by dropping them off with the collecting entity. It also provides guidance on how collected drugs must be destroyed.

Before Congress passed the Secure and Responsible Drug Disposal Act of 2010, patients wishing to dispose of unwanted pharmaceuticals had limited options: destroy the drugs themselves (generally by throwing them away or flushing them) or turn them over to law enforcement or the DEA. The 2010 Disposal Act authorized patients to give drugs to another party for disposal purposes if that party is authorized to receive them and the disposal occurs in accordance with regulations issued by the attorney general. The attorney general delegated responsibility for promulgating these regulations to the DEA.

Entities that will be permitted to collect drugs are authorized manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals and clinics with on-site pharmacies, and retail pharmacies. The Final Rule authorizes these entities to facilitate take-back programs in two ways: to create mail-back programs and to maintain collection receptacles. An entity that establishes a mail-back program must provide specific mail-back packages to the public either at no cost or for a fee. Collectors conducting a mail-back program also must have and utilize an on-site method of destroying returned packages.

No entity permitted by the Final Rule to implement a take-back program is required to do so, and patients are not obligated to participate in any such program in order to dispose of prescription drugs.

Current regulations do not specify a governing standard detailing how collected pharmaceuticals must be destroyed. The Final Rule now implements a standard of destruction—the collected drugs must be rendered “non-retrievable.” To meet this standard, a pharmaceutical must be “permanently alter[ed]” so that it is rendered “unavailable and unusable for all practical purposes.” The Final Rule does not require a particular method of destruction as long as the required result is achieved. The Final Rule also provides that pharmaceuticals that are collected may not be individually counted or inventoried.

Patients still will be able to dispose of medications with law enforcement. Federal, state and local law enforcement agencies can continue to maintain collection receptacles and administer mail-back programs, as well as hold take-back events.

The purpose of the Final Rule, which will go into effect October 9, 2014, is to address the growing problem of abuse of prescription drugs and to reduce the environmental impact of patients disposing of medications themselves.

DEA Authorizes Take-Back Programs for Pharmacies