New Draft Guidance Clarifies UDI Exceptions for Convenience Kits – FDA Law Blog

Hands holding a pen, above some papers“On January 4, CDRH issued its first draft device guidance of the year. The Draft Guidance “Unique Device Identification: Convenience Kits” explains FDA’s position as to what constitutes a convenience kit for purposes of the UDI Rule.”

Read the full article: Source: FDA Law Blog: New Draft Guidance Clarifies UDI Exceptions for Convenience Kits


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Full-line distributor sales reached $305 billion in 2013, representing 90% of pharma sales – Pharmaceutical Commerce

Assorted drug capsules and tabletsHDMA’s 2014-15 Factbook updates member financial, operational performance.

The just-published 2014-15 Factbook, a compilation of HDMA member data as well as relevant industry statistics, gives evidence that full-line wholesalers are running faster—shipping more products each day, while handling a higher daily average of orders. The report also provides a snapshot of what the industry was looking like in 2013 just as the Drug Supply Chain Security Act was passed; presumably, the report from a year from now will show how ready the industry was for the Jan. 1, 2015, deadline coming up for reporting transaction information to customers and FDA, per DSCSA requirements. ”

Learn more details, read the full article: via Full-line distributor sales reached $305 billion in 2013, representing 90% of pharma sales – Pharmaceutical Commerce.


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FDA Says > Know Your Source: Protecting Patients from Unsafe Drugs

Colorful photo of medication containers

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 sophisticated in the world, there is a growing network of rogue wholesale drug distributors selling potentially unsafe drugs in the U.S. market.”

Read the entire FDA article:  via Information for Healthcare Professionals (Drugs) > Know Your Source: Protecting Patients from Unsafe Drugs.  U.S. health regulators are trying to help doctors spot counterfeit and unapproved drugs by raising awareness of illegal operations that peddle bogus drugs to health professionals.


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NASP and SPAARx merge to create unified specialty pharmacy association – DrugStoreNews

Drug vials“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 strengths each has contributed to specialty pharmacy and the pharmacy industry as a whole, to develop a strong, unified voice representing all specialty stakeholders,” Gary M. Cohen, BSPharm, RPh, CSP, NASP CEO said.”

Read the full article: via NASP and SPAARx merge to create unified specialty pharmacy association – DrugStoreNews.


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