DEA's Regulatory Agenda Affects Pharma Supply Chain, Distribution and Disposal Regulations

The US Food and Drug's Administration's (FDA) Unified Agenda may have been released late last year, but it's not the only US regulatory agency with the potential to affect the medical device and pharmaceutical industries.

Several regulations proposed by the Drug Enforcement Administration (DEA), a division of the US Department of Justice, hold the potential to affect members of industry, and in particular the pharmaceutical industry.

One such proposed rule, Disposal of Controlled Substances, proposes to require a system in which manufacturers and users would need to secure leftover or otherwise unused controlled substances (any scheduled substance under the Controlled Substances Act, or CSA) for proper disposal.

"The proposed rule would also reorganize and consolidate existing regulations on disposal, including the role of reverse distributors, and propose a comprehensive regulatory framework for the collection and destruction of controlled substances consistent with the CSA," DEA wrote. The regulation is required under the terms of the Secure and Responsible Drug Disposal Act of 2010, and DEA has already sought opinions from industry in the form of a January 2009 Federal Register notice in which it called for "options for the safe and responsible disposal of dispensed controlled substance."

At issue could be who pays for the system-end users, the facilities that dispense the drugs, or the drug manufacturers-and what will it eventually entail? DEA's notice holds few details at this time. The rule is still in the proposed rule stage, and does not have any legal deadlines, meaning it could be well beyond 2013 before the final rule is seen or enacted.

DEA is also looking to implement several regulations aimed at preventing the proliferation of methamphetamines.

One such regulation, Implementation of the Combat Methamphetamine Epidemic Act (MEA) of 2005; notice of transfers following importation or exportation, would apply to importers, exporters and persons handling List I and List II chemicals. Those chemicals are those used in the manufacture of controlled substances under the CSA, and DEA has been looking to control their supply chain more carefully to prevent the types of diversions that can fuel the unregulated and illicit manufacture of meth. Under the proposed rule, the identified entities would have to provide DEA with information about to whom they will transfer the substance, as well as the amount to be transferred and a declaration that the transfer has occurred.

Final action on that rule is expected on or about 1 August 2012. A similar regulation, Self-Certification and Employee Training of Mail-Order Distributors of Scheduled Listed Chemical Products, would apply to mail-order distributors of scheduled listed chemical products, which would need to self-certify to DEA in order to sell the substances, which could in turn affect the sales of the products (and in particular cold remedies).

Yet another proposed regulation, Retail Sales of Scheduled Listed Products; Chemical; Self-Certification of Regulated Sellers of Scheduled Listed Chemical Products, would create 30-day and daily sales limits, require scheduled products to be sold from behind the counter of a retail operation, would mandate that the identification of purchasers be logged, and that all employees handling scheduled goods be trained and certified.

A final proposed regulation, set to be unveiled in June 2013, would revise current regulations regarding anabolic steroid products. DEA explained that the products are currently exempted under the law from the requirements of 21 USC 801-904. Its regulations, however, exempt it from 21 USC 951-971.

"DEA would revise its regulations to reflect the authority provided by Congress in the CSA and would review ways that the exemption process may be updated and streamlined," it wrote. "As such, DEA would repeal any portion of its regulations that allow the exemption of chemical preparations and anabolic steroid products from application of sections 1002, 1003, and 1004 of the CSA (21 U.S.C. 952-954) and its implementing regulations."