Tennessee Pharmacists Association

On May 23, 2016, 2:00 PM – 3:00 PM ET, the American Society of Health-System Pharmacists (ASHP) will conduct a free webinar on how FDA’s proposed changes to federal oversight of pharmacy compounding will impact providers and patients. The hour-long session will provide an overview of three draft guidance documents released last month that have the potential to fundamentally alter Section 503A compounding in hospital and health-system settings. Participants will have the opportunity to engage directly with ASHP staff during the question-and-answer period.

Register today at https://attendee.gotowebinar.com/register/3257314566725528835

FDA Draft Guidance Documents:

TPA will continue to work with key state and national pharmacy stakeholders to engage federal legislators and the FDA regarding these draft guidance documents and to advocate for changes which would permit office use compounding under the oversight of state boards of pharmacy. TPA plans to submit comments to FDA on the guidance documents, and encourages all members whose practices may potentially be affected by these proposed guidance documents to review them and submit comments to FDA.

To provide comments, click the links below.  (The deadline to submit comments is July 18, 2016, at 11:59 pm ET.) 

  • CLICK HERE to provide comments on Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act [Docket No. FDA-2016-D-0269]
  • CLICK HERE to provide comments on Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act [Docket No. FDA-2016-D-0271]
  • CLICK HERE to provide comments on Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act [Docket No. FDA-2016-D-0238]

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with its docket number, shown above. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

TPA also requests that members communicate specific comments and concerns to our staff (micah@localhost) so they can be communicated to our federal legislators and key pharmacy organizations.