Waiver of Requirements for the Distribution of Prescription Drug Products That Contain List I Chemicals

DEA is proposing to amend its regulations to waive the registration requirement for persons who distribute prescription drug products that are subject to regulation as List I chemicals and to allow that the records required to be maintained pursuant to the Federal Food and Drug Administration (FDA) guidelines for prescription drug products shall be deemed adequate for satisfying DEA's recordkeeping requirements with respect to distribution. In response to requests from industry, DEA has conducted a review and determined that such prescription drug products are already subject to extensive regulatory controls regarding their distribution and are not presently identified as a significant source for diversion of List I chemicals to the illicit manufacture of controlled substances. This proposed action will relieve a large population of distributors and manufacturers of regulated prescription drug products containing List I chemicals from the burden of compliance with regulations in circumstances where compliance would be unnecessary for enforcement of the law.