This should interest HME professionals: “Last week we announced FDA’s first-ever Patient Engagement Advisory Committee, which will provide advice to the FDA Commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients. We thought it would be good to step back and fill you in about our Patient […]
Tag: licensing
License Search for California Designated Representative-3PL
California Designated Representative Training for 3PL (third-party logistics providers) – Approved by the California State Board of Pharmacy The California Board of Pharmacy has enabled a license verification web page to: “License Search for California Designated Representative-3PL“ Source: California Board of Pharmacy License Search Go to DREprof.com: The Designated Representative and Exemptee Training Website California Designated […]
FAQ: Who needs an HMDR License?
Exemptee: California HMDR Training Certification QUESTION: Who needs an HMDR license from the California Department of Public Health, Food and Drug Branch (CDPH/FDB)? ANSWER: Any person conducting an HMDR business (retail facility or warehouse) in the State of California must first obtain a license from CDPH/FDB. A separate license is required for each location. The […]
Wholesale Distributor & Third-Party Logistics Providers Reporting – FDA Requirement
“The Federal Food, Drug, and Cosmetic Act as amended by the DSCSA, requires third-party logistics providers to begin reporting this information annually to FDA on November 27, 2014, while wholesale distributors are required to begin on January 1, 2015. FDA has issued a draft guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and […]
New California Licenses Required For Third-Party Logistics Providers (3PLs)
This announcement was just sent by the California Board of Pharmacy: “Companies that do not own, but receive, store and ship prescription drugs and prescription devices into or within California need to obtain a third-party logistics provider (3PL) license immediately with the California State Board of Pharmacy. Formerly, these entities were licensed as wholesalers or nonresident wholesalers by […]
Proposed Regulations for 3PL Providers – CA Board of Pharmacy
Here’s an update on the status of California Board of Pharmacy sponsored legislation to enact provisions to license third-party logistic (3PL) providers as a separate class, and not as the Board had previously done under the category of wholesaler. According to the December 17, 2014 meeting minutes of the Enforcement and Compounding Committee: Legislation was […]