Posts Tagged ‘DQSA’
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 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 MoreVeterinary Compounding: Recent State Legislation Updates
State boards of pharmacy continue to have primary responsibility of the day-to-day oversight of state-licensed pharmacies that compound drugs in accordance with Section 503A of the Food and Drug Cosmetic Act (FDCA) while the FDA regulates and inspects registered outsourcing facilities licensed under Section 503B of the FDCA. While the exact definition of compounding may vary…
Read MoreLouisiana Board of Pharmacy Addresses the Compounding of Veterinarian Only Drugs for Office Use
Earlier this year, the Louisiana Board of Pharmacy (Louisiana Board) exercised the emergency provision of the Louisiana Administrative Procedure Act (R.S. 49:9.53.B), to amend its rules governing the compounding of drugs by pharmacies and restored the capability for pharmacies to compound drugs intended for the administration by veterinarians without the necessity of a patient-specific prescription.…
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 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 MoreNotice to Florida Licensed Non-Resident Pharmacies
Beginning October 1, 2014, Florida requires all non-resident pharmacies to obtain a Nonresident Sterile Compounding Permit in order to ship, mail, deliver or dispense in any manner, a compounded sterile product into the State of Florida. Nonresident pharmacies that are compounding sterile products under their current Florida pharmacy permit may continue to do so if:…
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…
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