Posts Tagged ‘compounding’

A 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…

Veterinary 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…

FDA 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…

Louisiana 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.…

Veterinary 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…

Compounding Animal Drugs from Bulk Substances: Draft Guidance Update

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI) #230 entitled “Compounding Animal Drugs from Bulk Drug Substances.” The draft guidance describes FDA’s policies with regard to compounding animal drugs from bulk drug substances. When final, the guidance will reflect FDA’s current thinking on the issues addressed…

Veterinary 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…

Analyzing Colorado 2014 Prescription Drug Outlet Disciplinary Actions: Repeated Deficiencies

Baer Law recently completed an analysis of thirty-two (32) separate disciplinary actions against Colorado Prescription Drug Outlets (PDOs) by the Colorado State Board of Pharmacy (Board). The Board registers and licenses pharmacy businesses, both in-state and out-of-state, including: Prescription Drug Outlets; Wholesale distributors of prescription drugs; Manufacturers of prescription drugs; Other outlets; and Limited licenses.…

Georgia Board of Pharmacy Requiring Non-Resident Pharmacy Licensure

Until recently, the State of Georgia did not require non-resident pharmacies to obtain a license to ship medications into the State of Georgia. However, at the Georgia Board of Pharmacy’s (GBOP) September 2014 meeting, the GBOP enacted rules requiring non-resident pharmacies to obtain a non-resident pharmacy license before dispensing medications into the State of Georgia.…

Notice 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:…