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 […]
Home Medical Device Retail Exemptee Training
Home Medical Device Retail Exemptee Training by SkillsPlus Intl Inc. – Buy now! This online training course satisfies application requirements for anyone applying for an Exemptee License through the CA Department of Public Health, and who is responsible for overseeing prescription devices. This web-based training course addresses the following areas of HMDR knowledge and training: […]
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 FDA has issued a draft guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and […]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 […]
Compound Pharmacies Complain FDA is Compounding Their Problems – Pharmalot – WSJ
“The stepped-up oversight was hastened by a new law that bolstered FDA authority. But compounders say the get-tough approach is a double-edged sword. Hospitals, doctors and patients may eventually have more confidence in compounded’ medicines, but in the meantime costs and red tape have increased. And a new batch of proposed guidelines issued by the […]
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 […]