July 03, 2014
New Compounding and Outsourcing Facility Guidance Issued Just in Time for July 4th Holidays
By Karla L. Palmer –
Yesterday FDA provided drug compounders some pre-Fourth of July fireworks by issuing a slew of “policy documents” as part of the Agency’s implementation of the Compounding Quality Act (“CQA”) (Title I of the Drug Quality and Security Act (“DQSA”)), which was enacted November 27, 2013. The policy documents include a draft interim guidance, a proposed rule, a Final Guidance, and two revised requests for nominations for the bulk drug substance lists for both Section 503A and Section 503B compounders. FDA stated in its press release that these “actions are essential next steps in providing the compounding industry with the appropriate tools to comply with the law and advancing the FDA’s efforts to continue protecting patients.”
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Yesterday FDA provided drug compounders some pre-Fourth of July fireworks by issuing a slew of “policy documents” as part of the Agency’s implementation of the Compounding Quality Act (“CQA”) (Title I of the Drug Quality and Security Act (“DQSA”)), which was enacted November 27, 2013. The policy documents include a draft interim guidance, a proposed rule, a Final Guidance, and two revised requests for nominations for the bulk drug substance lists for both Section 503A and Section 503B compounders. FDA stated in its press release that these “actions are essential next steps in providing the compounding industry with the appropriate tools to comply with the law and advancing the FDA’s efforts to continue protecting patients.”
continue to read here
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