Posts Tagged ‘outsourcing facility’
FDA’s 2018 Priorities for Drug Compounding
After the fungal meningitis outbreak of 2012 that killed 76 patients and injured hundreds more, Congress passed the Drug Quality and Security Act (DQSA), which, in part, tried to bring more compounding pharmacies, traditionally overseen by state boards of pharmacy, under FDA oversight. The DQSA created a new entity, called ‘outsourcing facilities,’ that could register…
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On April 15, 2016, the FDA issued draft guidance on the Prescription Requirement Under 503A (Prescription Guidance).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 MoreA Texas Compounder, the FDA and the Texas Board of Pharmacy: State or Federal Oversight?
Last month the Food and Drug Administration (FDA) alerted health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by IV Specialty of Austin, Texas, due to lack of sterility assurance. The FDA found numerous safety issues during its February 2016 which prompted them to recommend…
Read MoreFDA Warning Letters Sent to California and Kentucky Compounders
The FDA recently issued two warning letters to compounders in California and Kentucky for violating current good manufacturing practices related to sterility. Ionia Pharmacy, based in Tustin, California, and Spoonamore Drug Co., located in Louisville, Kentucky, were both issued warning letters for deficiencies in: Producing sterile drug products and putting patients at risk, Not receiving…
Read MoreVeterinary Compounding: For "Office Use"
As the veterinary compounding market continues to grow and expand, new legal issues arise and, in some instances, the current federal and/or state laws may be in conflict with one another or they may not provide clear guidance on specific topics. Veterinary compounding for ‘office use,’ where a medication is compounded and then sold to…
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 MoreOutsourcing Facilities: Section 503B
The Drug Quality and Security Act (DQSA) can be separated into two sections: Title I addresses drug compounding and Title II relates to drug supply chain security. Section 503A of the Food, Drug and Cosmetic Act (FDCA) addresses compounding requirements, where as Section 503B defines and describes “outsourcing facilities.” Outsourcing Facilities are defined as a…
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…
Read MoreEnhancing FDA Communications: DQSA Update
The Food and Drug Administration (FDA) was granted some new authority this week by the Department of Health and Human Services (DHHS), its parent organization. The new authority, though not unexpected or substantial, pertains to the Drug Quality and Security Act (DQSA) which was passed in late 2013 in response to the deadly New England…
Read MoreDrug Quality and Security Act: Title II – Track and Trace System
The Drug Quality and Security Act (DQSA) was designed to clarify the Food And Drug Administration’s (FDA) oversight authority over drug compounding and update the federal drug tracking and tracing system. Title II of the DQSA seeks to reduce drug shortages, theft, counterfeiting and drug diversion by modernizing existing federal law and replacing current state…
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