Frequently Asked Questions About Pharmaceutical Compounding

What is compounding, and why is it necessary? Compounding is the creation of a pharmaceutical preparation—a drug—by a licensed pharmacist to meet the unique needs of an individual patient (either human or animal) when a commercially available drug does not meet those needs. A patient may not be…

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Compounding 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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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

 

COMPOUNDING NEWS
May 15, 2020
FDA extends comment period on animal drug compounding draft guidance to June 17

The draft guidance pertains to compounding patient-specific prescriptions for nonfood-producing animals, office stock for nonfood-producing animals, and antidotes for food-producing animals. Comments and criticism Some pharmacies that specialize in the compounding of medications for animal health…

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May 5, 2020
APhA coronavirus watch: FDA clarifies compounding rules for drugs in shortage during pandemic

FDA representatives on an APhA webinar said that the agency will look to 503B compounders to grapple with drug shortages and turn to 503A compounders to fill the gaps. Among the most notable of FDA’s clarifications is that medications on the agency’s drug shortage list are effectively considered…

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October 1, 2019
APhA Issues Statement on John Oliver's September 29 Segment on Compounding Pharmacies

Sunday night's episode of John Oliver's Last Week Tonight on HBO included a segment on pharmacy compounding. The American Pharmacists Association makes the following statement: In the quest for humor, important messages may have been lost in Sunday evening’s television rant deriding pharmacists’…

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September 18, 2019
Sterile Compounding Review and Recertification Activities

APhA has partnered with the U.S. Pharmacopeia (USP), the organization responsible for setting standards for sterile compounding, to plan and develop a comprehensive, innovative and professional development program for the Board of Pharmacy Specialties (BPS) Specialty in Compounded Sterile…

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August 30, 2019
Changes to USP <797>, addition of <800> having enormous impact on hospital pharmacies

USP <797> defines how sterile compounding must occur within a hospital pharmacy. The primary focus is on ensuring sterility and stability of compounded products prepared for parenteral administration. This goal is achieved by defining a plethora of practices and environmental requirements by…

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