Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Monday, November 18, 2013
Donna Barsky who has been a compounding pharmacists for 35 years and is owner of Texas Star Pharmacy in Plano questions the new legislation
WASHINGTON — Congress today took the final step in approving a bill that will put in place new federal standards for pharmaceutical compounders, something drug safety advocates have been calling for since a devastating fungal meningitis outbreak last year claimed at least 64 lives and sickened hundreds of others, at least two in Texas.
The bill, which passed the Senate Monday on a voice vote and will be on its way to the President’s desk, is summarized here. It’s a compromise bill that makes it voluntary for pharmacies that compound drugs on a large scale to register as so-called outsourcing facilities. Those that do registered, will be under greater government oversight and subject to more frequent federal inspections.
Those that do not will remain under the oversight of state regulators, usually as in Texas’s case, the state board of pharmacy.