“Blockchain startup Mediledger has published the results of its FDA blockchain pilot for the pharmaceutical supply chain. Numerous separate groups applied to the FDA and ran pilots for the Drug Supply Chain Security Act (DSCSA) 2023 milestone for package-level tracing, with this being one of the largest groups. Mediledger’s participants included all three major U.S. wholesalers, seven out of ten of the world’s largest pharmaceutical companies, massive dispensers Walgreens and Walmart, as well as logistics firms such as FedEx.”
Another industry that is feeling the impact of the coronavirus is the pharmaceutical industry. The average buffer inventory for the pharmaceutical industry is between three and six months. However, this does not tell the full story. Gaurav mentioned that China is responsible for producing 40 percent of the active pharmaceutical ingredients (APIs) for the pharmaceutical world. Additionally, China supplies 80 percent of key starting materials (KSM’s), which are the chemicals in APIs, to India. Put together, this represents 70 percent of all APIs across the world.
“After a search, the board of directors at the Healthcare Distribution Alliance has chosen Chester “Chip” Davis to be president and CEO. John Gray, HDA CEO since 2004, announced his retirement last year; Davis will take over next month. Davis comes to HDA from president and CEO of the Assn. for Accessible Medicines (the former Generic Pharmaceuticals Assn.), which appointed him in 2015. Formerly, he was EVP for advocacy at the Pharmaceutical Research and Manufacturers of America.”
“The Trump Administration wants to start a drug-importation program from Canada for both small-molecule and biologic products. The program would be a “time-limited Section 804 importation program” (SIP), with the SIP program sponsored by “a pharmacist, a wholesaler, or another State or non-federal governmental entity” and subject to FDA review. Additional language in the notice of proposed rulemaking (NPRM) gives guidance on how manufacturers themselves could set up reimportation. The NPRM is available in draft form today (Dec. 18), and is expected to be published officially in the Federal Register on Dec. 23.”
“The increased demand for CPAPs and disposables creates opportunities for home medical equipment (HME) and durable medical equipment (DME) suppliers. But a word of caution: The supplier can have no involvement with a home sleep test (HST) administered to a patient covered by Medicare fee-for-service (FFS).”
“In short, Medicare will not pay ABC for the CPAP if ABC is the provider of the sleep test. That term is defined as “the individual or entity that directly or indirectly administers and/or interprets the sleep test and/or furnishes the sleep test device used to administer the sleep test.””
SkillsPlus International Inc. proudly offers the largest selection of Board-approved California Designated Representative online training courses. Earns a Board-recognized training affidavit. More than 6,000 students trained!
California Designated Representative Online Training for Drug/Device Wholesalers
“The US FDA published a compliance policy final guidance document on September 23, 2019, announcing a one-year enforcement discretion for the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product.
If you’re a wholesaler or a manufacturer rushing to meet the November 2019 deadline, this guidance is significant. But before you breathe a sigh of relief, you need to read the entire guidance document and the entirety this LSPediA article.”