On May 30, 2018, Diana Amador, Program Division Director, Office of Pharmaceutical Quality Operations (OPQO), Division I, issued a letter to “Our Regulated Pharmaceutical Industry”. This letter offers firms an opportunity to submit all FDA 483 responses in electronic format up to 100 megabytes. If files exceed 100 megabytes, they may be submitted as smaller […]
As the compounding Industry awaits the next round of Guidances from FDA on using bulk drug substances, one point of controversy appears to be the fairness of compounding for 503A and 503B entities. The most recent Guidances for Compounding from Bulk Drug Substances are: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A […]
We have long heard arguments that traditional and Outsourcing compounding entities represent unfair competition to the generic drug industry and that they frequently circumvent the Federal Food, Drug and Cosmetic Act (especially the 2013 Drug Quality and Security Act, DQSA). A new tactic that has been recently used by a generic firm to protect its […]
Just days after FDA Commissioner Dr. Scott Gottlieb shared the 2018 Compounding Policy Priorities Plan, FDA issued three guidances: (1) Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act ; (2) Compounded Drug Products That Are Essentially Copies of Approved Drug […]
Commissioner Dr. Scott Gottlieb shared FDA’s 2018 Compounding Policy Priority Plan (here) providing an overview of the Agency’s key priorities to implement (and enforce) the federal law on compounding (Drug Quality and Security Act [DQSA], signed into law November 2013). He also states that this plan advances FDA’s mission to protect the health and safety […]
From August 2016 to October 2017, FDA has issued 63 Warning Letters (an average of 4 per month) and has orchestrated 4 Injunctions and multiple prosecutions against Compounding Pharmacies and their Principals. Most of the Warning Letters deal with citations for insanitary conditions for compounding and for lack of sterility assurance for compounded preparations. It […]
Looks like FDA is nearing the end of the daunting task of developing and (soon hopefully) publishing a “Difficult to Compound List” that has been in the works for nearly 17 years. At a meeting on July 13 and 14, 2000, an advisory committee on compounding (specifically, the Pharmacy Compounding Advisory Committee [PCAC]) provided FDA […]
Congress has introduced the Compounded Drug Access Bill, H.R. 2871. This blog article only addresses the first four sections of H.R. 2871, “Preserving Patient Access to Compounded Medications Act of 2017”. Here we go again with another introduced bill for pharmacy compounding. This six-page bills title (above) purports to “preserve” patients’ access to compounded drugs […]
For 503A and 503B compounding pharmacies, how do you protect your business from heavy-handed interventions from State and Federal Regulators? Can you affirmatively respond to the following questions? Do you know the Federal and State laws you are required to follow? Do you have the right enabling documentation (procedures, policies, records, etc., in place and […]
FDA issued the draft Guidance “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities” (here) in late December 2016. FDA reminds us that, under current law, radiopharmaceuticals that are compounded by entities that are not registered with FDA as outsourcing facilities (503B), and radiopharmaceuticals that are repackaged are subject to all applicable […]
