Drug compounders have new FDA guidance on identifying insanitary conditions at their facilities.
The Food and Drug Administration issued a draft guidance Aug. 3 to help compounding facilities identify insanitary conditions so that they can correct them. The guidance also will help state regulatory agencies understand what the FDA considers to be insanitary conditions.
Comments on the draft guidance, identified by Docket No. FDA-2016-D-2268, are due Oct. 3. A notice announcing the draft guidance was published in the Aug. 4 Federal Register (81 Fed. Reg. 51,449).
John Voliva, executive vice president of the International Academy of Compounding Pharmacists (IACP), told me in an Aug. 3 e-mail that IACP “is appreciative of the FDA's efforts to further define and clarify what the Agency feels are insanitary conditions.”
“We do have concerns around some items which could be related to cGMP [current good manufacturing practice] and will fully identify these issues in our comments,” Voliva said. “However, overall, this draft guidance, along with the FDA’s recent notice regarding inspections, gives the industry a clearer picture as to the agency’s process when it comes to investigations of pharmacies who comply with Section 503A of the Federal Food, Drug, and Cosmetic Act.” Section 503A describes the requirements for traditional compounding pharmacies.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)