20
Apr
Capsules in mortar

Emergency Preparedness – FDA Continues Active Oversight in the Compounding Space

FDA has been discussing using temporary enforcement discretion in two April 2020 Guidance for Industry documents for sterile compounding during the Covid-19 crisis: “Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency (here)” and “Temporary Policy Regarding Non Standard PPE Practices for Sterile Compounding by […]

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08
Apr
flying money

Out of Sight – Out of Mind – Not Hardly and No Refunds

FDA issues Guidance for Industry: “Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act, April 2020”. With all that’s going on with Covid-19, FDA is diligently executing their priorities for this fiscal year.  In FY19, FDA’s priorities for Compounding (human drugs) were to: maintain quality manufacturing and compliance; […]

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12
Sep
Bending, Breaking or Moving On Image

Bending, Breaking or Moving On: FDA Expands on its 2018 Compounding Policies Priorities

On September 7, 2018, FDA Commissioner Scott Gottlieb stated that the FDA will expand on their implementation of their 2018 Compounding Priorities Plan and that they feel like they must continue to balance the need to preserve access to appropriately compounded drugs for patients who have a medical need for these products with the need […]

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11
Sep

The Devil is in the Details:  Requirements for State Boards of Pharmacy under the Draft Standard MOU Regarding 503A Compounding and Intrastate and Interstate Distribution

The FDA estimates that the burden of information collection under their newly revised draft Memorandum of Understanding (MOU) (here) and reporting to the FDA to be about 7600 hours per year per state (assuming approximately 2000 work hours per year; this equates to about four new employees per year per state).  The FDA also estimates […]

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01
Aug

Welcome to the 21st Century – FDA Goes Greener!

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 […]

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27
Feb
Policy isolated on elegant green round button abstract illustration

Compounding Fairness???

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 […]

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30
Jan

Is There a New Tactic for Generic Manufacturers to Use to Hit a Bullseye?

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 […]

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26
Jan
FDA Starts Push for Transparency in Fulfilling Their 2018 Compounding Policy Priorities Plan Image

FDA Starts Push for Transparency in Fulfilling Their 2018 Compounding Policy Priorities Plan (Part II)

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 […]

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23
Jan
Bending, Breaking or Moving On Image

Thought FDA Was Tempering Back Its Oversight and Enforcement of Compounding Operations? Think Again!

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 […]

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