Posts Tagged ‘pharmaceutical compounding’

Colorado Board of Pharmacy Update: Non Resident Affidavit

In late 2017, the Colorado Board of Pharmacy (Board) sent notice to all non resident pharmacies licensed with the Board. The notification addressed the distribution of medications into Colorado. In part, the notification stated the following: “Colorado law and Board rule (CRS 12-42.5-118.5 and Board Rules 21.00.20(d)) allow a non resident pharmacy (“Pharmacy”) to distribute…

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…

North Carolina Pharmacy Law Update: Properly Identifying the Compounding Risk Levels and Notifying the Board

Pharmacies that hold a permit in North Carolina and engage in any type of compounding are required to notify the North Carolina Board of Pharmacy (Board). Pharmacies must report (both on their initial permit application and as part of each annual renewal) the following: Whether they compound; A good-faith estimate of the percentage of the…

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…

FDA'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Last week the Food and Drug Administration (FDA) announced three new Draft Guidance documents related to drug compounding under the Sections 503A and 503B of the Food, Drug and Cosmetic Act (FDCA): Hospital and Health System Compounding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…

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…

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.…