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 […]

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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 […]

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Design Considerations for Devices Intended for Home Use – FDA Guidance

Read the full guidance:  Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff (PDF – 205KB) As stated in the guidance, “This guidance is intended to assist manufacturers in designing and developing home use devices that comply with applicable standards of safety and effectiveness and other […]

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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 […]

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Federal government renews charges of illicit drug distribution involving FedEx – Pharmaceutical Commerce

“It has been the contention of DEA and the Dept. of Justice for several years that companies involved in shipping and delivering controlled substances must ensure that both providers and shipment recipients are authorized (licensed) to make or receive these shipments. In “normal” distribution, a licensed manufacturer of such drugs ships them to a licensed […]

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CA Home Medical Device Retailer (HMDR) FAQs

“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.  The Sherman Law was amended in the 1999-2000 legislative session to establish the HMDR licensing program. …  Also found below is a link to […]

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