This topic is coming up a lot lately. There appears to be confusion about whether work experience satisfies the training program requirement, or vice versa. In a nutshell, if you are applying for a California Designated Representative or Exemptee License, you’ll have to meet both the work experience requirement, and the training program requirement (i.e., completing […]
Tag: wholesaler
FDA Says > Know Your Source: Protecting Patients from Unsafe Drugs
“Beware of Rogue Wholesale Drug Distributors Wholesale drug distributors are a link between manufacturers and health care professionals. Their role is to ensure prescription medications are delivered safely and efficiently to thousands of health care practitioners and pharmacies nationwide every day. While the U.S. health care supply chain is one of the most secure and […]
Industry groups take issue with guidance on outsourcing facilities
“GPhA says compounders and outsourcing facilities should abide by the same inspection criteria as other drug manufacturers. “Drug manufacturers with U.S-based facilities are required to be inspected by FDA at least every 24 months,” GPhA says. “Compounders producing sterile products should be held to similar standards.” Similarly, BIO disagrees with FDA’s proposed alternative approaches for […]
HDMA – Issues in Distribution: Pharmaceutical Traceability and the Drug Supply Chain Security Act
“The Drug Supply Chain Security Act (DSCSA, or Title II of the Drug Quality and Security Act) was enacted on November 27, 2013. The act replaces a 50-state patchwork of pedigree requirements with one federal traceability solution for prescription medicines, and raises licensure standards across the U.S. The law will transform how the domestic supply […]
Free Tips – Florida Designated Representative (CDR) Exam Prep
Florida Certified Designated Representative – CDR Exam Prep Course Simply studying for the Florida Certified Designated Representative (CDR) examination isn’t enough! Many candidates only study the exam subjects and content, then take what’s considered a difficult exam. Some of these same candidates don’t pass the exam. As you prepare for the examination, you have to […]
NASP and SPAARx merge to create unified specialty pharmacy association – DrugStoreNews
“The National Association of Specialty Pharmacy and the Specialty Pharmacy Association of America announced the merger of the two organizations, creating the largest professional and trade association focused on the unique needs in specialty pharmacy. “This is a historic moment in our industry — one in which our two organizations come together, recognizing the unique […]