FDA Guidance Update
Wednesday, January 18, 2017
Posted by: IACP
FDA Announces Revisions to Two Final Guidances
The Food & Drug Administration (FDA) has announced revisions to two final guidance documents:
• Final Guidance: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
• Final Guidance: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act
On the 503A Guidance above, the FDA has removed everything IACP had requested from Category 3 of the Bulks list – including: capsules, lecithin soya granular, loxasperse, MBK, medium cream, pracasil, shea butter, simplgel, supposibase-F, tommygel, some cosmetic ingredients, L-triiodothyronine, T3 sodium dilution, quinine, splenda, buffer solution, minerals, triglycerides and water (and additives).
Please click here to view IACP’s letter request to FDA from August 2016.
FDA Bans Sale and Use of Powdered Medical Gloves
Effective January 18th, 2017, the FDA has banned the sale and use of powdered medical gloves. According to the agency, “… Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is banning these devices.” Pharmacies who currently use powdered medical gloves should stop doing so immediately.
FDA Clearly States “No Office Use” Compounding by 503A Pharmacies
With the publication of the final guidance, “Prescription Requirement Under Section 503A of the Federal Food, Drug and Cosmetic Act,” the FDA has now clearly stated, in final guidance, it believes the provision of compounded drug products via a drug order or non-patient-specific prescription to physician offices or other health care settings is prohibited under Section 503A. If your pharmacy participates in “office use” compounding or compounding for office administration without receiving a patient specific prescription, the FDA will assert your pharmacy is in violation of Section 503A and loses the exemptions provided within the law (compliance with cGMP, requirements for the New Drug Application process and proper labeling requirements).
Additionally, this guidance has set up requirements for anticipatory compounding. IACP will be providing a summary of this guidance to IACP members in the coming weeks.
FDA Action Summary
Please click here to view IACP's summary of FDA actions taken since December 15, 2016.
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