FDA Provides Clarity on Use of Estriol by Section 503A Compounding - TopicsExpress

FDA Provides Clarity on Use of Estriol by Section 503A Compounding Pharmacies Specifically, the FDA has indicated that drug products containing Estriol may be compounded in accordance with Section 503A by a licensed pharmacist pursuant to a patient-specific prescription, based on the fact that Estriol is the subject of an applicable USP monograph. The FDA provided this statement in an email response to this office following several questions submitted by us following the passage of the Drug Quality and Security Act of 2013. pbmauditlawyers.blogspot/2014/11/fda-provides-clarity-on-use-of-estriol.html

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