Archive for May 2015
Compounding Animal Drugs from Bulk Substances: Draft Guidance Update
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI) #230 entitled “Compounding Animal Drugs from Bulk Drug Substances.” The draft guidance describes FDA’s policies with regard to compounding animal drugs from bulk drug substances.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…
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 MorePhantom Pharmacist-in-Charge Offers
The Oklahoma Board of Pharmacy (Board) is reporting that Oklahoma-licensed pharmacists are being approached by out-of-state pharmacies (OSP) asking them to be their pharmacist-in-charge (PIC) for their Oklahoma license, despite the fact that the Oklahoma licensed pharmacists to not actually work at the OSP. The increased frequency of requests for “phantom” or “absent” PICs is…
Read MoreColorado Pharmacy Reaches HIPAA Settlement
Last month, the U.S. Department of Health and Human Service’s Office for Civil Rights (OCR) announced that Cornell Prescription Pharmacy (Cornell Pharmacy) in Denver, Colorado agreed to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). As part of the settlement, Cornell Pharmacy has agreed to pay a $125,000 penalty…
Read More