Georgia limits office use compounding to outsourcing facilities

6120124167_917a86f78b_bAn amendment to the Georgia Pharmacy Practice Act that went into effect July 1, 2016, authorizes the Board of Pharmacy to create rules for the permitting of outsourcing facilities and third-party logistics providers in Georgia. This change allows the state to recognize and create its own rules for outsourcing facilities under Section 503B of the Federal Food, Drug and Cosmetic Act. Those rules, once published, may be more restrictive than the minimum federal standards enforced by the FDA.

The new law makes it explicitly clear that an independent compounding pharmacy may only compound human drug products for “office use” at a licensed outsourcing facility. There is a carve out for hospital-based pharmacies and pharmacies owned or operated by hospitals, as well as for medical doctors who compound drugs for administering or dispensing to their own patients. (more…)

5 rules for a compounding pharmacy facing an FDA inspection

survey-1594962_960_720The FDA has put greater scrutiny on compounding pharmacies since August 2016, with inspectors making preliminary assessments on compliance for patient-specific prescriptions and other rules under Section 503A of the federal Food, Drug and Cosmetic Act.

The change allows investigators to cite deviations from the current good manufacturing practices when it appears the pharmacy does not qualify for exemptions. So a compounding pharmacy, operating under the belief that it is exempt from certain requirements, can now suddenly find itself criticized for failing to adhere to those requirements. (more…)