Category: Consulting

Starting Materials for Drug Products: Analysis of 108 FDA Form 483’s issued to Compounding pharmacies in 2018 was performed. A textual analysis for the term non-pharmaceutical identified approximately 11% of the facilities (12) received an observation associated with the use of non-pharmaceutical products as an ingredient (starting materials) and 1 case where a non-pharmaceutical cleaning […]

This past week two warning letters to 503B outsourcing facilities were posted to the FDA website. In one of the warning letters, the outsourcing facility compounded drugs using raw material not on the 503B bulks list, failed to include all drugs compounded in the prior 6-months, and failed to report an adverse event within the required […]

Are you a 503B trying to understand the FDA Regulation and Inspection Guide?  Do you feel like these guys? I have a limited number of FDA Guidebooks that contain the FDA regulations 21 CFR parts 210 and 211 cGMPs in Manufacturing, Processing, Packing, or holding of drugs and finished pharmaceuticals AND the Drug Manufacturing Inspections: […]

On March 11 FDA Commissioner Scott Gottlieb provided a statement in the request for new FDA Funding. The full FDA statement is available here. Below is the excerpt concerning funding requested to Strengthen the FDA’s oversight of compounded drugs to help secure patient safety: The practice of compounding medicine can provide important public health opportunities. The FDA’s […]

January 2018, FDA Commissioner Scott Gottlieb issued the FDA 2018 Compounding Policy Priorities Plan on the FDA website. This communication provides a summary background on how the FDA became involved in compounding pharmacies, and a summary of how FDA will prioritize actions to protect the public health as obligated under DQSA. I found the following section particularly interesting: […]

FDA has issued revision 2 to the cGMP Guidance for Outsourcing Facilities. The draft guidance is available here. And is open for public comment. As noted in the FDA announcement: This revised draft guidance describes FDA’s policies regarding compounders registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as outsourcing facilities […]

The Challenge A pharmacist seeking to build a new 503B Outsourcing Facility requested assistance in the understanding and implementation of current good manufacturing practices (cGMPs) and the FDA risk based inspection processes. Background:  In 2012, the CDC and USFDA investigated a multistate outbreak of fungal meningitis and other infections among patients who received contaminated preservative-free […]

“The USP has established that the acceptable range of most compounded preparations is typically ±10%; however, it can be as great as ±20% (as with some proteins) or as tight as ±5% (as with potent analgesics). For some raw powders, potency is required to be within ±2%”, (Kupiec, 2005, p. 136; Rooney & Heuvel, 2004). […]