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: course
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 […]
Your Florida CDR just quit. What do you do?
“My company is a prescription drug wholesale distributor (in-state or out-of-state). Our Certified Designated Representative (CDR) just quit. What do we do? Notify the department within 10 business days from the CDR’s separation. Your company may continue to distribute prescription drugs in or into Florida during that 10-business day-period. After that period expires, however, your company must either (a) […]
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 […]
The Differences Between The DSCSA, FDA Rules and Guidance – RxTrace
How To Approach, Read, and Interpret the DSCSA Another great educational snippet from Dirk Rodgers (RxTrace). Follow the link below to read his full article. “So let’s apply that to the exchange of Transaction Information TI, Transaction History TI, and Transaction Statements TS that all U.S. pharma supply chain trading partners must do beginning on […]