What Are The FDA's CGMPs? Ramifications for Compounding Outsourcing Facilities

On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA), legislation that contains important provisions relating to the oversight of compounding of human drugs. In the new law, a compounder can become an “outsourcing facility.” Outsourcing facilities must comply with CGMP requirements. (Source:  FDA.gov - Compounding Quality Act - Title I of the Drug Quality and Security Act of 2013)

The FDA (Food and Drug Administration) puts forth the cGMP regulations (current good manufacturing practice). The CGMPs are also commonly referred to as:

• GMP - good manufacturing practice, or
• CGMPR (current good manufacturing practices regulations)

If you're unfamiliar with the FDA cGMPs, then consider taking this online course:

21 CFR 211: Pure, Safe, and Effective - an introduction to the FDA cGMPs

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California Pharmacy Law Changes for 2014

Hot off the press.

The Board of Pharmacy just posted California Law Changes for 2014 as a PDF document. The PDF states, "Provided below are code sections that were added or amended during the 2013 Legislative Session. Unless otherwise indicated, all of the provisions go into effect on January 1, 2014."

Follow this link to CA Board of Pharmacy - California Laws Changes for 2014 (PDF)

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Don’t Skip The DQSA Definition of Terms Section - RxTrace

Follow the link below, and heed Dirk Rodgers/RxTrace advice. Here's a sampling of glossary terms that might interest you:  dispenser, distribution, exclusive distributor, repackager, 3PL provider, wholesale distributor.

Don’t Skip The DQSA Definition of Terms Section - RxTrace:

"Section 581, Definitions, is a special glossary of terms whose definitions only apply within the text of the law.  So if you read the other sections and you assume the dictionary or the everyday definition of certain terms, you will miss the full meaning of those sections."

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Compounding > Registered Outsourcing Facilities - FDA.gov

Follow the FDA.gov link below to view a list of the registered firms . . .

Compounding > Registered Outsourcing Facilities - FDA.gov:

"Firms Registered As Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)"

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Home Medical Equipment Market Report 2012 - 2018 - SBWire

Home Medical Equipment Market Report 2012 - 2018 | Jan 6, 2014 - SBWire:

"It is estimated that the U.S. will be the largest market for home medical equipments owing to its wide base of home healthcare equipment providers, good reimbursement policies, better healthcare infrastructure and high healthcare expenditure. Moreover, the recent changes in the healthcare industry due to ‘Obamacare’ will also boost the demand for such equipment, since almost 30 million uninsured Americans will now enjoy medical coverage."

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