FDA´s New Regulations for Drug Manufacturers

The US Food and Drug Administration (FDA) amends its requirements for foreign and domestic establishment registration and listing for human drugs, including drugs that are regulated under a biologics license application, and animal drugs.

The final rule revises FDA's longstanding regulations governing drug establishment registration and drug listing. The amendments are aimed at modernizing these regulations and improving efficiency and reliability for both - FDA and drug manufacturers.

The more than two hundred pages final rule is expected to come into effect 90 days after publication in the Federal Register (scheduled August 31, 2016).

Up to now drug manufacturers have been required to register their establishments with FDA annually. Among other things, drug establishment registration identifies establishments for inspection by FDA. Furthermore, for each registered establishment it is required to submit a list of drugs it manufactures. The amendments adopted by this final rule modernize those regulations and bring them into conformance with recent amendments of the FD&C Act.

The FDA states that "the amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process."

In summary, the final rule requires electronic submission, unless waived in certain circumstances, of drug establishment registration and listing information. The electronic submission requirement is consistent with FDAAA (Food and Drug Administration Amendments Act) and with current practice. Thus, the final rule clarifies and completes the modernization of FDA´s electronic registration and listing systems.

Establishment registration and listing obligation rests with persons who manufacture, repack, relabel, or salvage drug products. The rule does not require persons who act only as private label distributors of drug products to register establishments or list drugs, but allows them to submit drug listing information as agents acting on behalf of persons who manufacture, repack, relabel, or salvage drug products. Also revised is the statute to specifiy that registrants must review and update registration information between 1 October and 31 December each year.

The revisons make several adjustments to the timing and substance of the submission of information to register a drug establishment and list drugs manufactured, repacked, relabeled, or salvaged at the establishment. Additionally the provisions governing FDA disclosure of drug registration and listing information, stating that with certain exceptions, establishment registration and drug listing information is generally available for public disclosure, have been updated.

For more information please see the final rule Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs.