Posts Tagged ‘patient specific compounded products’

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 More

FDA'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On April 15, 2016, the FDA issued draft guidance on the Prescription Requirement Under 503A (Prescription Guidance).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 More

FDA'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  Last week the Food and Drug Administration (FDA) announced three new Draft Guidance documents related to drug compounding under the Sections 503A and 503B of the Food, Drug and Cosmetic Act (FDCA): Hospital and Health System Compounding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…

Read More

Notice to Florida Licensed Non-Resident Pharmacies

Beginning October 1, 2014, Florida requires all non-resident pharmacies to obtain a Nonresident Sterile Compounding Permit in order to ship, mail, deliver or dispense in any manner, a compounded sterile product into the State of Florida. Nonresident pharmacies that are compounding sterile products under their current Florida pharmacy permit may continue to do so if:…

Read More