Posts Tagged ‘office use’
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…
Read MoreFDA’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…
Read MoreDistribution of Compounded Prescription Drugs for Animal Use into Colorado
In late 2017, the Colorado Board of Pharmacy (Board) sent notice to all facilities registered with the Board as nonresident pharmacies. The notification addressed the distribution of medications into Colorado. The notification states, in part, the following: “Colorado law and Board rule (CRS 12-42.5-118.5 and Board Rules 21.00.20(d)) allow a nonresident pharmacy (“Pharmacy”) to distribute…
Read MoreFDA's Most Recent Guidance: Prescription Requirements Under Section 503A
On April 15, 2016, the FDA issued draft guidance on the Prescription Requirement Under 503A (Prescription Guidance). The Prescription Guidance sets forth the FDA’s policy concerning prescription requirements for compounding human drug products for identified individual patients under Section 503A of the Federal Food, Drug and Cosmetic Act (FDCA) and addresses: Compounding after the receipt…
Read MoreVeterinary 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…
Read MoreLouisiana 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.…
Read MoreVeterinary 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…
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