JD Supra

Major Changes in Drug Compounding and Drug Distribution Requirements (Part 1 of 2)

On September 28, 2013, the U.S. House of Representatives passed the Drug Quality and Security Act (H.R. 3204). The bill is compromise legislation crafted by the Senate Health, Education, Labor, and ...
ACHR News

HVAC Design Considerations for Pharmaceutical Preparations

Pharmaceutical suites are subject to strict requirements regarding the air supplied to and exhausted from their preparation, storage, and distribution areas. Designing for an appropriate level of ...
Purdue University

Purdue-related startup develops virtual cleanroom educational tool to teach pharmaceutical compounding, sterile techniques

WEST LAFAYETTE, Ind., and INDIANAPOLIS – A Purdue-related startup is developing the first USP 797 certified, virtual pharmacy cleanroom laboratory for students and other industry professionals to gain ...
JD Supra

Drug Quality and Security Act Gives FDA Authority to Regulate Drug Compounding and Creates Uniform Federal Standards for Distribution

On Nov.18, Congress enacted sweeping changes to the laws governing the safety of the drug supply. The Drug Quality and Security Act (the act) clarifies FDA's authority to regulate drug compounding. It ...
PharmTech

Compounding Overview: Primary Considerations for the Workplace

Technical, regulatory, and personnel considerations characterize pharmaceutical compounding. Pharmaceutical compounding comprises activities associated with preparation of dosage forms that are not ...