Cheryl A. Thompson
BETHESDA, 01 Aug 2014-A document from offers clues as to the extent that sterile drug products from outsourcing facilities will be made under conditions different from those described in the () standards for pharmaceutical compounding.
Fifty-one sites as of July 25, according to the agency, had registered as compounding outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act.
The sites have been able to register without paying a fee.
But come October 1, the first official registration period opens and fee collection starts.
In preparation, on July 1 issued a draft of "Current Good Manufacturing Practice - Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act" (PDF) and invited comments from the public.
According to pharmacy consultant E. Clyde Buchanan, pharmacists can expect sterile drug products from FDA-registered outsourcing facilities "to be made under conditions more stringent" than those specified in USP chapter 797.
That is because FDA drafted current good manufacturing practice (CGMP) requirements that impose "a higher level of quality control and quality assurance activities," he explained.
Buchanan runs an eponymous consulting firm and is a coauthor of Compounding Sterile Preparations, Third Edition, published by ASHP.
continue to read here
BETHESDA, 01 Aug 2014-A document from offers clues as to the extent that sterile drug products from outsourcing facilities will be made under conditions different from those described in the () standards for pharmaceutical compounding.
Fifty-one sites as of July 25, according to the agency, had registered as compounding outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act.
The sites have been able to register without paying a fee.
But come October 1, the first official registration period opens and fee collection starts.
In preparation, on July 1 issued a draft of "Current Good Manufacturing Practice - Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act" (PDF) and invited comments from the public.
According to pharmacy consultant E. Clyde Buchanan, pharmacists can expect sterile drug products from FDA-registered outsourcing facilities "to be made under conditions more stringent" than those specified in USP chapter 797.
That is because FDA drafted current good manufacturing practice (CGMP) requirements that impose "a higher level of quality control and quality assurance activities," he explained.
Buchanan runs an eponymous consulting firm and is a coauthor of Compounding Sterile Preparations, Third Edition, published by ASHP.
continue to read here
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