Posts Tagged ‘FDCA’
Two Pharmacists Sentenced to Prison for Adulteration of Drugs
On June 21, 2016, the Department of Justice announced that two Alabama pharmacists were sentenced to prison terms of 12 and 10 months for their roles in the distribution of adulterated drugs. The drugs in question were compounded at the now-defunct compounding pharmacy Advanced Specialty Pharmacy (dba: Meds IV.) Meds IV allegedly compounded numerous drugs…
Read MoreFDA's Most Recent Guidance: Prescription Requirements Under Section 503A
On April 15, 2016, the FDA issued draft guidance on the Prescription Requirement Under 503A (Prescription Guidance). The Prescription Guidance sets forth the FDA’s policy concerning prescription requirements for compounding human drug products for identified individual patients under Section 503A of the Federal Food, Drug and Cosmetic Act (FDCA) and addresses: Compounding after the receipt…
Read MoreFDA's Most Recent Guidance: Hospitals and Health System Drug Compounding
Last week the Food and Drug Administration (FDA) announced three new Draft Guidance documents related to drug compounding under the Sections 503A and 503B of the Food, Drug and Cosmetic Act (FDCA): Hospital and Health System Compounding Prescription Requirement Under Section 503A Clarifying the definition of “Facility” under Section 503B This article will focus…
Read MoreVeterinary Compounding and the Drug Quality and Security Act
The Drug Quality and Security Act (DQSA) amends the Federal Food, Drug and Cosmetic Act (FDCA) with respect to human drug compounding. As discussed previously on the Baer Law Blog, Title I of the DQSA amended Section 503A of the FDCA and added Section 503B. Sections 503A and 503B address exemptions from certain FDA requirements…
Read MoreDesigner Anabolic Steroid Control Act of 2014 (H.R. 4771)
In December 2014, President Obama signed into law H.R. 4771, the Designer Anabolic Steroid Control Act (DASCA) of 2014. The DASCA amends the Controlled Substance Act and adds over 20 specified substances to the list of those included within the definition of “anabolic steroid” and provides that a drug or hormone substance (other than estrogens,…
Read MoreFDA's Guidance on Compounding for Human Use
As discussed previously on the Baer Law Blog, Title I of the Drug Quality and Security Act (DQSA) gives the Food and Drug Administration (FDA) new powers to oversee drug compounding. Section 503A of the DQSA sets out certain requirements for traditional compounding, while Section 503B creates a new entity called outsourcing facilities. This blog…
Read MoreCompounding: Section 503A Changes
The regulatory landscape for pharmacy compounding has changed immensely since the passage of the Drug Quality and Security Act (DQSA) in November 2013. Historically, the Food and Drug Administration (FDA) has not strictly enforced pharmacy compounding under the FDA Modernization Act of 1997. However, the passage of the DQSA, which updated Section 503A of the…
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