The most up-to-date regulatory policy information related to pharmaceutical compounding can be found on the U.S. Food & Drug Administration's website right arrow


February 5, 2018
Resources for Your Practice

Compounding Quality Act, Information on Compounding (U.S. Food and Drug Administration) Compounding Standards and Resources (U.S. Pharmacopeial Convention) Guidelines for Compounding Practices - This chapter from The Art, Science, and Technology of Pharmaceutical Compounding, 5th edition (…

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December 14, 2017
Drug repackagers, compounding pharmacies continue to stress workers' comp systems

The number of physician dispensed prescriptions has declined considerably from just a few years ago, but the workers' compensation industry continues to battle an adapting market seeking to maintain high prices by changing drug strength and formulations. Kathy Fisher, assistant director of external…

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November 6, 2017
Pharmacies say FDA is going too far in enforcing drug compounding law

Compounding pharmacies say FDA overstepped its authority when it enacted the Drug Quality and Security Act (DQSA) of 2013 by not allowing office-use compounding, which is when a pharmacist makes a drug without receiving a prescription and sends it to a requesting physician to hold onto for when it…

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October 30, 2017
Endo International units sue FDA over drug compounding policy

Endo International announced two subsidiaries have sued FDA alleging it improperly authorized the bulk compounding of hundreds of drugs, including "essentially a copy" of Endo's blood pressure drug vasopressin (Vasostrict). The lawsuit comes after FDA Commissioner Scott Gottlieb said last month the…

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September 27, 2017
Gottlieb on new efforts to encourage compounding of better quality drugs under DQSA

In a statement, FDA Commissioner Scott Gottlieb, MD, discussed the importance of FDA oversight of drug compounding. He noted that "compounded drugs, while important to patients who need them, pose ongoing and serious risks if they are not manufactured properly." Gottlieb said, "As a physician, I…

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