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NABP e-News January 10, 2007
FDA Provides PDMA Background Information in Response to Federal Court Decision
Following the federal court decision that prevented the Food and Drug Administration (FDA) from implementing certain provisions of rules it had issued to implement the Prescription Drug Marketing Act (PDMA), FDA released two documents that seek to clarify how it intends to implement the remaining enforceable provisions. FDA maintains that distributors which are not authorized distributors of record (ADR) still must pass pedigrees prior to each wholesale distribution, but, pursuant to the court injunction, those pedigrees do not have to include lot numbers, container sizes, or the number of containers, and do not have to include the chain of custody back to the original manufacturer. At this time, pedigrees need only document transactions back to the manufacturer orto the last ADR that distributed the prescription drug.
Was January 1 the Deadline for DMEPOS Suppliers to Become Accredited?
In a word: no. The definitive deadline for suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) accreditation is still unconfirmed. There is no January 1, 2007 deadline - a date that has been widely but incorrectly reported. The Centers for Medicare and Medicaid Services (CMS) advises that DMEPOS suppliers in Miami and the 10 Metropolitan Statistical Areas (MSA), yet to be determined, will need to be accredited by the spring of 2007 in order to participate in the competitive bidding process. More information on DMEPOS accreditation requirements and NABP's DMEPOS accreditation program is available in the Accreditation Programs section of NABP's Web site at http://www.nabp.net.
NABP Presents DMEPOS Webinar for Pharmacy Chain Executives
NABP staff recently presented an educational Webinar for executives of community pharmacy chains to discuss CMS' Quality Standards and accreditation requirements, and NABP's accreditation program for DMEPOS suppliers. The Webinar (teleconference with Web-based visual presentation) focused on the application process for chain pharmacies to receive DMEPOS accreditation through NABP. Information on the accreditation process for all DMEPOS pharmacy-suppliers is available on NABP's Web site at http://www.nabp.net. NABP staff is available to provide similar presentations to other pharmacy groups. Staff can be contacted at dmepos@nabp.net.
Eight Facilities Awarded VAWD Accreditation
NABP recently accredited eight new facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 34. A full listing of VAWD facilities is available in the VAWD section of NABP's Web site, http://www.nabp.net.
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Cardinal Health 200, Inc, dba Cardinal Health, is the medical products and services group of Cardinal Health. The company received VAWD accreditation for the following facilities:
- McGaw Park, IL
- Waukegan, IL
- Indianapolis, IN
- Louisville, KY
- Cincinnati, OH
- Obetz, OH
- Henry Schein, Inc, is a distributor of health care products to office-based practitioners. The company received VAWD accreditation for its Sparks, NV facility.
- Sunbelt Medical Supply, Inc, dba Sun Belt Medical/Emergi-Source, is a distributor of EMS pharmaceuticals and IV therapy supplies. The company received VAWD accreditation of its Hilton Head Island, SC facility.
Liberty Medical Supply Receives VIPPS Accreditation
Liberty Medical Supply, Inc earned NABP's Verified Internet Pharmacy Practice Sites™ (VIPPS®) accreditation on December 26, 2006. Liberty, which is located online at http://www.libertymedical.com, has been offering home delivery of health care products for more than 17 years. The company provides patients with medical products and services including diabetes supplies, prescription medications, and ostomy products and accessories. A full listing of VIPPS pharmacies is available in the VIPPS section of NABP's Web site at http://www.nabp.net.
