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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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