Tuesday, April 30, 2013

e-Pedigree Updates - CA Rx Board - Enforcement Comm Mtg 3/14/13 (Video)

More e-Pedigree conversations, taking place at CA Board of Pharmacy meetings.


Here's a video from the Enforcement Committee Meeting of March 14, 2013 that covers the following agenda items (Tip: e-Pedigree discussion starts at the 2 hr & 9 min mark):

Discussion on the Implementation of California’s Electronic Pedigree - Requirements for Prescription Medication
  • A. Update on the Status of Proposed Regulations to Implement Serialized Numeric Identifiers, Grandfathering and Manufacturer Reporting of How the 50 Percent Threshold of Serialized Products on January 1, 2015 Has Been Determined (Proposals to Add Title 16, California Code of Regulations, Sections 1747 and 1747.1)
  • B. Presentations and Questions from the Pharmaceutical Supply Chain on Their Readiness to Meet California’s Staggered E-Pedigree Implementation Schedule
  • C. Discussion Concerning Elements for Possible Regulation Requirements to Permit Inference as Provided by California Business and Professions Code Section 4163
  • D. Discussion on the Certification Process to Comply with California’s E-Pedigree Law
  • E. Discussion on the Use of Drop Shipments in an E-Pedigree System
  • F. General Discussion/Questions and Answers
Additional information:
Meeting agenda & materials

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Friday, April 12, 2013

FDA Summary - 2013 Compounding Pharmacy Inspections

Pharmacy Compounding > Summary: 2013 FDA Pharmacy Inspection Assignment:
"The agency is currently evaluating the information obtained during the inspections and where applicable, will apply its existing legal authority to protect the public health. For the firms that are operating outside the bounds of traditional pharmacy compounding and who had significant sterile production issues, FDA plans to take aggressive action, including through enforcement actions, as appropriate."

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Wednesday, April 10, 2013

Round 2 Contract Suppliers Listed

CMS Announces Round Two Contractors -- HME Business:

"Finding Contract Holders

To find Round Two contract holder, the Competitive Bidding Implementation Contractor, Palmetto GBA, has released a PDF listing all the contract holders at [. . .]

Also, CMS’s online searchable supplier directory is already showing which providers are holding competitive bidding contracts. To find the contract-holders for specific categories in specific areas, visit [. . .]  and enter the zip code in question; select up to five product categories; and then scroll down and click the green “search” button."

Resources:
DMEPOS Competitive Bidding Program - Contract Supplier List - Round 2 and National Mail-Order (pdf)
Medicare.gov - Supplier Directory - Find a Supplier by Zip Code

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