FDA Anticounterfeiting Business Practices Seem To Be Met By NABP Rules

The National Association of Boards of Pharmacy¹ Model Rules for the Licensure of Wholesale Distributors appear to satisfy FDA's call for stakeholders to develop secure business practices.

FDA's ² final report on "Combating Counterfeit Drugs" requests that "for government efforts against counterfeit drugs to be successful, drug producers, distributors, and dispensers will have to take effective actions to secure their business practices."

The model rules include more stringent licensing requirements: background checks, extensive disclosure, inspections and due diligence procedures prior to transactions.

The rules mandate that if a wholesaler has purchased from another distributor a drug that is listed as susceptible to counterfeiting, that wholesale distributor "shall, at least quarterly, conduct random authentications of pedigrees on at least ninety percent (90%) of sales units" of such drugs.

NABP adapted their ³ list of susceptible drugs from a list developed by the Florida Department of Health. Thirty-one products "posing the potential for a greater public health risk" are included on the list.

The list "represents a starting point for states that have an imminent need for such direction," NABP said Feb. 27.

Florida created its list as part of its "Prescription Drug Protection Act," which also creates tighter requirements on drug distributors (⁴ (Also see "Florida Pedigree Enforcement For 30 “Specified” Drugs Begins Sept. 1" - Pink Sheet, 30 Jun, 2003.), p. 27).

The association plans to have its list revised on an annual basis.

A standing committee, to be called the Drug Advisory Coalition, will be appointed by mid-2004 in order to update the list and develop the standards for the revision process. The coalition will include members from the NABP, FDA and industry stakeholders.

The agency has said that it supports the creation of a list of drugs susceptible to counterfeiting but has not developed one independently.

FDA plans to build a counterfeit drug alert network as part of a multi-layered approach outlined in its final report.

"To increase awareness of counterfeit drugs and safeguard the [nation's] drug supply, FDA is creating a network of national organizations, consumer groups, and industry representatives to deliver time-sensitive messages and information about specific counterfeit incidents and educational messages about counterfeits in general," the final report states.

FDA is planning to make certain internal changes to better deal with the problem of counterfeits.

"To respond rapidly to a report of a suspect counterfeit, FDA is further streamlining its internal processes to respond quickly to reports of suspect counterfeit drugs by improving coordination and communication among all initial responders in the agency," the report states.

Changes made to MedWatch will be another layer of FDA's anticounterfeiting effort.

"FDA plans to change the instructions for the MedWatch reporting form, both paper and online versions, so reporters will know how and when to report suspect counterfeits," the final report states.

The agency re-launched a public service announcement in conjunction with the release of the final report (⁵ (Also see "FDA Anticounterfeiting PSA Urges Public To Verify Web Pharmacy Licensure" - Pink Sheet, 23 Feb, 2004.), p. 17).

A second PSA is to be released in the coming weeks educating consumers on how to identify possible counterfeit drugs (see ⁶ ).

The final report's main thrust is the encouragement of widespread adoption of radio frequency identification technology by 2007 as a means to secure the drug supply chain (⁷ (Also see "FDA Anticounterfeit Carrot & Stick: Radio Frequency I.D., No Paper Pedigree" - Pink Sheet, 23 Feb, 2004.), p. 14).

Congressional legislation introduced during the first week in March would require electronic coding for certain controlled substances by 2006 (⁸ (Also see "House Bill Calls For Electronic Pedigree For Controlled Substances By 2006" - Pink Sheet, 8 Mar, 2004.), p. 17).

[Editor's Note: A version of this story first appeared in ⁹ "The Pink Sheet" DAILY . Visit our website, www.ThePinkSheetDAILY.com, to sign up for a free trial.]