The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act...more
The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more
Yesterday, the U.S. Food and Drug Administration (FDA) released five documents outlining the FDA’s current policies regarding compounded drug products for human use. All of the documents are available through the FDA’s...more