The FDA just published: Guidance for Industry – Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification (PDF) William Koustas (FDA Law Blog) writes, “The DSCSA tasked FDA with addressing three issues in this guidance: (1) identifying scenarios that could increase the risk of suspect product entering the supply chain; (2) recommending […]
Tag: program
California HMDR Laws
California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (approved by the California Department of Public Health – Food and Drug Branch) “The Home Medical Device Retailer (HMDR) licensing program is administered as part of the Medical Device Safety Section and is governed by law found in the California Sherman Food, Drug and Cosmetic Law. […]
Prolonged Power Outages Can Be Deadly for People Who Rely on Durable Medical Equipment | Huffington Post
“Already this year, American communities have experienced floods, tornadoes and wildfires. Our country needs a better way to protect medically fragile people so natural disasters don’t become medical emergencies. Thousands of people in the United States rely on electrically powered DME to meet their medical needs at home. While they can manage their medical conditions […]
Medicare to expand ‘prior authorization’ for device coverage | TheHill
“In a shift from the current system, Medicare is proposing to rule on seniors’ coverage for home medical devices before the supplies are delivered or claims for payment are submitted. The Centers for Medicare and Medicaid Services CMS is planning to expand the use of “prior authorization” for power scooters and wheelchairs, and introduce the […]
Apply for a Designated Representative License – CA Board of Pharmacy
Follow the link below to find and download the application form that you need, including Designated Representative, and Wholesaler applications: “Apply for a License – Please select the license type you wish to apply for to download the application and instructions.” – via CA Board of Pharmacy – Apply for a License. Go to DREprof.com: The […]
FDA Law Blog: Interoperably Exchanging Information with FDA: Agency Holds First DSCSA Public Workshop
Follow the link below for a sobering report of the FDA’s first DSCSA public workshop, and the short implementation timeline that faces the supply chain: “Without an issued guidance, however, what are supply chain members to do in the meantime? Perhaps the most important thing to do is to try to understand the DSCSA, and how different […]