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NABP e-News December 27, 2007
CMS Announces Accreditation Deadline for All DMEPOS Suppliers
All suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) must be accredited by September 30, 2009, Centers for Medicare and Medicaid Services (CMS) announced. Suppliers not accredited by that date will lose their National Supplier Clearinghouse billing privileges. The announcement came during a "Special Open Door Forum" conference call on December 19, 2007. An audio recording of the forum will be available on December 27 via the CMS Web site at www.cms.hhs.gov/OpenDoorForums/05_ODF_SpecialODF.asp. CMS named NABP an accrediting organization for pharmacies that supply DMEPOS products in November 2006. The NABP DMEPOS accreditation program is best suited for pharmacies that provide a limited line of durable medical equipment.
NABP, APhA to Evaluate Impact of State Laws on New DEA Multiple Prescription Rule
A new rule modifying Drug Enforcement Administration (DEA) regulations on prescribing Schedule II controlled substances may pose challenges in states that have stricter regulations on such prescriptions. NABP and American Pharmacists Association (APhA) will evaluate the possible impact of the new rule and will compile information for pharmacists regarding potential implementation challenges. Effective December 19, 2007, the rule amends DEA regulations to allow practitioners to provide an individual patient with multiple prescriptions for a specific Schedule II controlled substance, written on the same date, to be filled sequentially. The change will allow patients to receive over time up to a 90-day supply of the prescribed controlled substance. The Controlled Substances Act does not permit the refilling of Schedule II controlled substances; a new prescription must be issued for each quantity of the substance. The rule is published in the November 19 Federal Register (Docket No. DEA-287).
Adverse Event Reporting Requirements for OTC products Effective December 22
Food and Drug Administration recently issued new adverse event reporting requirements for manufacturers, packers, and distributors of dietary supplements and over-the-counter (OTC) drug products marketed without an approved application. The new reporting requirements, as described in Public Law 109-462, became effective on December 22, 2007. The act, as well as the FDA Guidance for Industry: Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed without an Approved Application, are available via the FDA MedWatch Web site.
Six Additional Facilities Awarded VAWD Accreditation
NABP recently accredited six new facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 230 as of December 21, 2007. A full listing of VAWD facilities is available under Accreditation on the NABP Web site.
- Abbott Laboratories ships prescription products manufactured by Abbott or its contractual entities to wholesalers, hospitals, and practitioners. The company received accreditation for its Abbott Park, IL facility.
- Becton, Dickinson and Company, dba BD Distribution Center, is the single returns center for all BD domestic operations, including prescription drugs to be quarantined and eventually destroyed. The company received accreditation for its Swedesboro, NJ facility.
- Gulf Coast Pharmaceuticals, Inc distributes pharmaceuticals and medical supplies to hospitals, physician's offices, pharmacies, and other wholesalers nationwide. The company received accreditation for its Ocean Springs, MS facility.
- Letco Medical, Inc, dba the Letco Companies, is a subsidiary of the Harvard Drug Group, LLC and primarily distributes repackaged products to compounding pharmacies nationwide. The company received accreditation for its Decatur, AL facility.
- ProCare Pharmacy Direct, Inc, dba PharmaCare Specialty Pharmacy #2921, is part of ProCare Pharmacy, Inc, a subsidiary of CVS Corporation, and provides mail-order support to CVS businesses. The company received accreditation for its Pittsburgh, PH facility.
- Triplefin LLC is a third party logistics provider for approximately 40 companies. The facility ships products including non-controlled prescription drug samples and non-drug-related items primarily to physicians. The company received accreditation for its Cincinnati, OH facility.
