NABP e-News April 18, 2007

States Tighten Wholesaler Licensure Requirements to Protect Against Counterfeit Drugs
The states continue to make progress in tightening licensure requirements for wholesale drug distributors in an effort to protect their citizens from counterfeit drugs that might otherwise infiltrate the supply chain. So far during this legislative session, three states have passed legislation giving the Boards of Pharmacy greater authority in the accreditation of wholesale drug distributors. In addition, each of these states requires pedigrees for prescription drugs that leave the normal distribution channel and requires the Board to set a targeted implementation date for track-and-trace technology for tracking prescription drugs through the supply chain.

  • Idaho: Senate Bill 1184, signed into law on March 30, gives the Board the authority to recognize an accreditation body to inspect and accredit wholesale distributors.
  • North Dakota: House Bill 1455, signed into law on March 29, requires wholesale distributors conducting business in North Dakota to obtain accreditation through the NABP Verified-Accredited Wholesale Distributors® (VAWD®) program or other Board-approved accreditation process. The legislation takes effect on August 1.
  • South Dakota: House Bill 1155, signed into law on March 26, like the Idaho bill, gives the Board the authority to recognize an accreditation body to inspect and accredit wholesale distributors.

Washington Board Obliges Pharmacies to Fill Lawfully Prescribed Drugs, Including Emergency Contraceptives
The Washington State Board of Pharmacy has ruled that pharmacies have a duty to deliver lawfully prescribed drugs in a timely manner, regardless of individual pharmacists’ personal objections to any particular medication, except in cases of obvious or known errors, contraindications, or suspected fraud. The rule was prompted by a controversy over some pharmacists' objections to selling emergency contraceptives. Washington Governor Chris Gregoire pushed for the new rule, as did women's advocates and the Washington State Pharmacy Association. The rule, which is expected to take effect on June 1, 2007, accommodates pharmacists’ moral objections by allowing pharmacies to assign alternate staff members to fill any prescriptions in question.

Tampering Results in Misbranding of Ziagen as Combivir and Use of Counterfeit Labels
GlaxoSmithKline and Food and Drug Administration (FDA) warned health care professionals of an apparent third-party tampering that resulted in the misbranding of Ziagen as Combivir and employed counterfeit labels for Combivir Tablets. Two 60-count misbranded bottles of Combivir Tablets contained 300 mg tablets of Ziagen. The counterfeit labels identified are Lot No. 6ZP9760 with expiration dates of April 2010 and April 2009. The incident appears to be isolated and limited in scope to one pharmacy in California. Pharmacists are advised to immediately examine the contents of each bottle of Combivir in their pharmacy to confirm that the bottles contain the correct medication. If a bottle contains anything other than Combivir Tablets, pharmacists are advised to notify the manufacturer. The letter from GlaxoSmithKline and FDA, containing photos of actual Combivir and Ziagen Tablets, is posted at http://www.fda.gov/medwatch/safety/2007/Ziagen_Dear_RPh_03-29-2007.pdf.

Four Facilities Awarded VAWD Accreditation
NABP recently accredited four new facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 91. A full listing of VAWD facilities is available in the VAWD section of the NABP Web site.

  • McKesson Corporation dba McKesson Drug Company distributes Class II-V controlled substances, legend pharmaceuticals, and over-the-counter (OTC) products to customers in Ohio, Kentucky, West Virginia, and Indiana. The company received accreditation for its Washington Courthouse, OH facility.
  • McKesson Specialty Distribution, LLC distributes Class II-V controlled substances, legend pharmaceuticals, and OTC products to practitioners nationwide. The company received accreditation for its Washington Courthouse, OH facility.
  • St Mary's Medical Park Pharmacy provides pharmaceutical services for occupational and orthopedic health care clinics. The company received accreditation for its Oro Valley, AZ facility.
  • Willow Birch Pharma, Inc exclusively distributes supplies to the veterinary industry. The company received accreditation for its Taylor, MS facility.

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