FDA Announces Exercise of Enforcement Discretion on Imminent Track and Trace Requirements – FDA Law Blog

Wooden gavel sitting on law books“On December 24th, in response to industry requests, FDA issued a guidance document indicating that it will not enforce product tracing requirements of the Drug Supply Chain Security Act (“DSCSA”) prior to May 2015. The guidance, states in relevant part:” . . .

Read the full article: via FDA Law Blog: In Keeping With the Spirit of the Season, FDA Announces Exercise of Enforcement Discretion on Imminent Track and Trace Requirements.

Read the FDA guidance: DSCSA Implementation: Product Tracing Requirements — Compliance Policy – FDA Guidance for Industry (PDF)


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FDA > Are you ready for the Drug Supply Chain Security Act?

FDA logo in blueBecome familiar with the law 

There are new requirements under the Drug Supply Chain Security Act (DSCSA) for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Some requirements began in November 2014 and several key requirements begin at various stages in 2015. The new requirements, development of standards, and the system for product tracing will continue to be phased in over the next nine years. FDA will continue working with trading partners and other stakeholders to effectively implement the new requirements.

Read the full article: via Drug Supply Chain Security Act > Are you ready for the Drug Supply Chain Security Act?.


Go to DREprof.com: The Designated Representative and Exemptee Training Website

 

California HMDR Exemptee – Minimum Qualifications

Woman pondering a question

Many California Home Medical Device Retailer (HMDR) Exemptee applicants have questions about the minimum qualifications for Exemptee eligibility.

If you navigate to, and open up the HMDR Exemptee Application (PDF), here’s what you’ll see:

Minimum qualifications:

  • Education: High school diploma GED or equivalent. Attach copies of any applicable certifications or licenses that you may hold.
  • On-the-Job Training: Attach copies of current employer’s training records listing job-specific training provided and dates completed.
  • Work Experience: One or more years paid experience, attach dates, name(s) of employer(s), and addresses. Training must have been supervised by a licensed exemptee, Pharmacist-In-Charge or equivalent.
  • Training Programs: Indicate by yes or no the training you have completed specific to the five topics listed. Attach copies of certificates or transcripts.”

Source:
State of California – Health and Human Services Agency – California Department of Public Health Food and Drug Branch – Application For Home Medical Device Retailer Exemptee License – New and Renewal (Form CDPH 8695 dated 04/16)


Go to DREprof.com: The Designated Representative and Exemptee Training Website