Just posted, the CA Board of Pharmacy – California Law Changes for 2015 (PDF). It covers all code sections that were added or amended during the 2014 Legislative Session. Unless otherwise indicated, all of the provisions go into effect on January 1, 2015. Go to DREprof.com: The Designated Representative and Exemptee Training Website CA Designated […]
FDA Announces Exercise of Enforcement Discretion on Imminent Track and Trace Requirements – FDA Law Blog
“On December 24th, in response to industry requests, FDA issued a guidance document indicating that it will not enforce product tracing requirements of the Drug Supply Chain Security Act (“DSCSA”) prior to May 2015. The guidance, states in relevant part:” . . . Read the full article: via FDA Law Blog: In Keeping With the […]
FDA > Are you ready for the Drug Supply Chain Security Act?
Become familiar with the law There are new requirements under the Drug Supply Chain Security Act (DSCSA) for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Some requirements began in November 2014 and several key requirements begin at various stages in 2015. The new requirements, development of standards, and the system for […]
California HMDR Exemptee – Minimum Qualifications
California HMDR Exemptee Training Certification Course for home medical device retailers (accepted by the California Department of Public Health – Food and Drug Branch) Updated February 19, 2021: Many California Home Medical Device Retailer (HMDR) Exemptee applicants have questions about the minimum qualifications for Exemptee eligibility. If you navigate to, and open up the HMDR Exemptee Application (PDF), […]
FDA Recommends New Testing Standards for Home Use Devices | RAPS
“A final guidance document issued by the US Food and Drug Administration (FDA) aims to make medical devices used by patients in their homes safer and more reliable. Background In general, medical devices can be divided into two categories: Those intended to be used in professional settings by healthcare professionals, and those intended to be […]
Full-line distributor sales reached $305 billion in 2013, representing 90% of pharma sales – Pharmaceutical Commerce
“HDMA’s 2014-15 Factbook updates member financial, operational performance. The just-published 2014-15 Factbook, a compilation of HDMA member data as well as relevant industry statistics, gives evidence that full-line wholesalers are running faster—shipping more products each day, while handling a higher daily average of orders. The report also provides a snapshot of what the industry was […]