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2018 FDA Priorities Affecting 503B Facilities

February 5th, 2018

On January 16th, 2018, FDA Commissioner, Scott Gottlieb, M.D. issued the 2018 Compounding Policy Priorities Plan. This document outlines, what the commissioner describes as, key priorities the agency will pursue to implement the federal law on compounding and to advance the FDA’s public health mission. At a very high level, this plan signals some major changes in compounding regulation that will certainly impact the operations of both 503A and 503B compounding facilities. Below, we have...

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2018 FDA Priorities Affecting 503A Facilities

February 5th, 2018

On January 16th, 2018, FDA Commissioner, Scott Gottlieb, M.D. issued the 2018 Compounding Policy Priorities Plan. This document outlines, what the commissioner describes as, key priorities the agency will pursue to implement the federal law on compounding and to advance the FDA’s public health mission. At a very high level, this plan signals some major changes in compounding regulations that will certainly impact the operations of both 503A and 503B compounding facilities. Below, I have...

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The Importance of Method Validation for the Testing of Compounded Medications

January 24th, 2018

Compounding Evolution Over the past decade, the compounding industry has been in a state of continuous evolution, in a large part due to the tragic consequences of the 2012 N.E.C.C. fungal meningitis contamination. As a result, the FDA has been applying pressure to the State Boards of Pharmacy to develop meaningful regulations for compounders. There is little doubt that, over time, these regulations will begin to mirror those currently enforced by FDA on drug manufacturers...

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FDA Considers Compounding Pharmacy Regulations

September 27th, 2017

The Federal Drug Administration (FDA) is planning changes to their current regulations that guide compounding pharmacies, potentially removing some scrutiny from smaller 503A pharmacies. The FDA is working towards a policy aimed at encouraging more compounding pharmacies to register under the Drug Quality and Security Act (DQSA). Under the DQSA, there were two types of compounding pharmacies created: 503A and 503B. 503B compounding pharmacies must register with the FDA, while 503A’s do not have to....

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Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act

February 2nd, 2017

Requirement 503A Pharmacies banned from compounding for docs without prescription The US Food and Drug Administration (FDA) says compounding pharmacies must not manufacture medicines for hospitals and doctors’ offices, except for named patients. Impact Statement 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...

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