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

Resumo

DEA is amending its regulations to waive the registration requirement for persons who distribute prescription drug products that are subject to regulation on List I chemicals and to allow that the records required to be maintained pursuant to the Federal Food and Drug Administration (FDA) regulations for prescription drug products shall be deemed adequate for satisfying DEA's recordkeeping requirements with respect to distribution. In response 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 there is no evidence that the products are being diverted at this time. This action will relieve distributors and manufacturers of regulated prescription drug products containing List I chemicals from the chemical control requirements in circumstances where compliance would be unnecessary for enforcement of the law.