The U.S. Food and Drug Administration issues guidance titled “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal, Food, Drug, and Cosmetic Act.” This document explains how the agency will apply Section 503A of the Food, Drug, and Cosmetic Act as amended under the Drug Quality and Security Act. Among other matters, it describes conditions that licensed pharmacists and physicians must satisfy in compounding drugs to be exempt from certain sections of the law.
The U.S. Food and Drug Administration requests comments on draft guidance titled “Current Good Manufacturing Practice—Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act.” The document sets forth the agency’s expectations of outsourcing facilities subject to current good manufacturing practices requirements while the agency develops industry-specific regulations under amendments to the Federal Food, Drug, and Cosmetic Act. Comments should be submitted by September 2, 2014.
The U.S. Food and Drug Administration reopens the comment period for a notice requesting “suggestions, recommendations and comments on innovative packaging, storage and disposal systems, technologies or designs that could be used to prevent or deter misuse and abuse of opioid analgesics by patients and others.” On its own initiative, the agency has extended the original June 9, 2014, comment deadline to August 7.
The U.S. Patent and Trademark Office requests comments from participants on all aspects of the new administrative trial proceedings under the America Invents Act, including the final rules and trial practice guide issued in August and September 2012. The comment deadline is September 16, 2014. Administrative trial proceedings include inter partes review, post-grant review, covered business method patents review, and derivation proceedings.