Posts Tagged ‘compounding’
Eli Lilly Sues Two Compounders Over Weight-Loss Drug Copies
Eli Lilly (Lilly) has sued two compounders, Strive Pharmacy LLC (Strive) and Empower Clinic Services LLC (Empower), for selling unapproved compounded tirzepatide, the main ingredient in Lilly’s popular weight-loss and diabetes medication Compounders like Strive and Empower were allowed to produce copies of obesity drugs while the FDA said there was a drug shortage. However,…
Read MoreFDA and NABP Partnership: Information-Sharing for Drug Compounding
The Food and Drug Administration (FDA) recently announced that it awarded a cooperative grant to the National Association of Boards of Pharmacy (NABP) to create an information-sharing data system to improve the information available to state regulators and the FDA about state-licensed pharmacies that engage in interstate distribution of compounded drugs. The new data system…
Read MoreDistributing Compounded Drugs to Colorado Veterinarians
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 MoreColorado 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 MoreNorth 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…
Read MoreTwo 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…
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 MoreFDA'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…
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