[01/23/15] The U.S. Food and Drug Administration issued a notice in the Federal Register today, announcing that a meeting of the Pharmacy Compounding Advisory Committee will take place on February 23-24, 2015.
The committee provides advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). During the meeting, the committee will discuss:
- The list of bulk drug substances that may not be compounded under the exemptions provided by sections 503A and 503B of the FD&C Act because the drug products or their components have been withdrawn or removed from the market because they were found to be unsafe or not effective. On July 2, 2014, FDA published a proposed rule that would add 25 drug products to this list and modify the description of one drug product on this list to add an exception. This discussion will include the comments FDA received on the proposed rule.
- The list of bulk drug substances that may be used for compounding under the exemptions provided by section 503A of the FD&C Act. On December 4, 2013 and July 2, 2014, FDA published notices in the Federal Register soliciting nominations for this list. The committee will discuss six of the nominated substances, inviting nominators to make a short presentation supporting each drug substance nomination.
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
- Written submissions may be made to the contact person on or before February 9, 2015.
- Presentations from the public will be scheduled at the following approximate times:
February 23, 2015:
- 10:15 to 10:45 a.m.
- 3:35 to 3:50 p.m.
February 24, 2015:
- 9:30 to 9:45 a.m.
- 11:45 a.m. to 12 p.m.
Those individuals interested in making formal oral presentations should notify the contact person to register to speak and to submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 12, 2015.
To register for the meeting or for information, please visit the FDA Pharmacy Compounding Advisory Committee web page.