FDA raises the bar on regulations
On June 8, 2006, the US Food and Drug Administration endorsed the recommendations of its Counterfeit Drug Task Force as outlined in the Counterfeit Drug Task Force Report: 2006 Update (1).
As a result, drug distributors will be required to provide pedigree, or chain-of-custody, documentation about products that pass through their hands after Dec. 1, 2006 when the stay expires. FDA defines a drug pedigree as "a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them. Under the pedigree requirement, each person who is engaged in the wholesale distribution of a prescription drug in interstate commerce, who is not the manufacturer or an authorized distributor of record for that drug, must provide to the person who receives the drug a pedigree for that drug" (2).
Because members of the pharmaceutical supply chain have known since the passage of the PDMA that pedigree documentation would be required at some point and several states have passed pedigree laws, the Task Force believes "FDA can no longer justify delaying implementation of these regulations" (1). It also thinks that "continuing the stay would perpetuate the current confusion and further allow opportunities for counterfeit and diversionary practices to flourish" (1).
The Task Force also feels meeting federal pedigree requirements should be less of a burden now because members of the pharmaceutical supply chain are already working to comply with a growing number of state pedigree requirements.
Once the stay expires, the Task Force recommends the agency take a risk-based approach to enforcement and focus initially on the drug products that are most vulnerable to counterfeiting and diversion, thus allowing the industry to adopt a phased pedigree implementation. The agency has issued draft Compliance Policy Guide (CPG) 160.900 that describes four factors for field personnel to consider when enforcing pedigree requirements.
According to the draft CPG, pedigree requirements will be enforced initially for products that meet one or more of the following criteria:
Guidance documents do not contain legally enforceable requirements, but rather describe the agency's current thinking and should be viewed as recommendations unless specific regulations or statutes are cited. Comments on the draft CPG were due July 14, 2006. A final document is expected to be published before the stay expires on Dec. 1, 2006.