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Updates on 503A Compounding: Legal and Regulatory Developments

Part 1 of this 2-part series examines USP <797> and <795> revisions for sterile and nonsterile compounding, veterinary compounding, FDA inspections of 503A pharmacies, and the interstate distribution of compounded prescriptions post Wellness Pharmacy v. FDA. ....

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Pharmacies Win Remand Of FDA's Compounded Drug Memo

A D.C. federal judge on Tuesday ordered the U.S. Food and Drug Administration to either perform an analysis of its memorandum that created new regulations to fully implement a decades-old rule governing pharmacy compounding, or certify that the memo won't greatly impact small businesses, like the pharmacies challenging the memo. ....

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NCPA files amicus curiae brief in compounding case

NCPA
February 26, 2021
On Feb. 25, NCPA, in conjunction with other interested stakeholders in the compounding pharmacy space, filed an amicus curiae brief in the
Wellness Pharmacy, Inc. v. Cochran case. At the center of the litigation is the Oct. 26, 2020, memo of understanding between the FDA and approving states which would govern dist¬¬ribution requirements for compounding pharmacies preparing drugs for interstate patients. States that signed the MOU would have Board of Pharmacy reporting requirements to the FDA for compounders shipping more than 50 percent of their products interstate, while compounders in states that did not sign would be limited to 5 percent of their products available for interstate patients. The plaintiffs allege the FDA did not properly follow established protocols. NCPA, on behalf of its compounding members, is concerned over the legality of FDA’s actions and the compliance burdens placed on compound ....

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