Drug Distribution

News & Analysis as of

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished Prescription Drugs: How to...

On December 8, 2014, FDA issued new guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers”. As the title suggests, the Guidance is part of FDA’s...more

GPhA Issues Statement Regarding Proposed IP Provisions of Trans-Pacific Partnership Agreement

The Generic Pharmaceutical Association (GPhA) issued a statement today regarding ongoing talks between major Pacific Rim countries (including the U.S.) related to the proposed Trans-Pacific Partnership Agreement. This trade...more

“Hustlin’” to a Legal Victory: Rick Ross and the Right of Publicity

California gives you the right to profit from your own identity. But what if you assume somebody else’s? Rick Ross is famous for rapping about cocaine. Ricky D. Ross is famous for selling it. Ross (the cocaine...more

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

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 also creates uniform...more

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 Pension ("HELP") and House...more

Health Reform + Related Health Policy News - July 2013

In This Issue: - Top News ..Obama Administration Delays Employer Mandate One Year ..House Energy and Commerce Committee Releases Draft Legislation for SGR Fix ..CMS Proposes Payment Changes for Medicare...more

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