2005N-0403
  

  
 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs

  


  

  

  


  

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC9
  



  

  
Submitter : 
  

  
Mr. Bob van Osdel
  

  
Date & Time: 
  

  
12/07/2006 11:12:10
  



  

  
Organization : 
  

  
Anabolic Laboratories, Inc.
  



  

  
Category : 
  

  
Drug Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 FDA has not adequately addressed the definition and listing requirements for contract drug product manufacturers.  Increasingly, plaintiffs attorneys are turning to drug listing information as proof of ownership in civil cases, but FDAs lack of clear rulemaking fosters an inaccuracy.  This is especially important considering the stated goal of making electronic listing information more publicly available.  FDA has partially addressed this issued with more clarity in the medical device listing rule at 21 CFR 807.20(a)(2) and has implied it in it IOM [see Exhibit 5-11] and with form FDA 2657.  But a more definitive definition would benefit both industry and drug listing branch personnel without affecting public safety or FDAs ability to identify actual manufacturing sites.



It is clear from this proposed rule that CDER continues to assume all drug product distributors that cause products to be manufactured by a contractor are private label distributors, but nothing could be farther from reality.  A significant number of distributors are in point of fact manufacturers as FDA has described them in responses to several comments in the preamble to the final rule on Foreign Establishment Registrations and Listing [Federal Register / Vol. 66, No. 228 / Tuesday, November 27, 2001].  FDA discussed this related to both biological product license holder and medical device manufacturers.  Specifically, FDAs response to comment 45 stated The comment is correct that ? 807.20(a)(2) exempts contract manufacturers from the listing requirements&  The current 807.20(a)(2) defines contractor listing exemptions as, & a person who only manufactures devices according to another person's specifications, for commercial distribution by the person initiating specifications&  Moreover, Exhibit 5-11 in FDAs IOM, which summarizes the listing requirements for manufacturers and distributors of human pharmaceuticals, states that contract manufacturers need only list Products packaged/marketed under the contract manufacturer's own label& Accordingly, it is clear that if a contractor manufactures, packages, and labels drug product according to the distributors specifications, then they are not his and he does not need to list them.



We are asking FDA revise proposed rule 21 CFR 207 to include a clear definition of a drug product contract manufacturer that is consistent with FDAs other centers, such as in 21 CFR 807, and that clearly exempts contractors from listing drug products that are not their own.  This will have no affect on public safety from these drug products and yet still provide FDA with clear identity of the contract manufacturer and his location.  On present form FDA 2657, on which the specification-holder would list the drug product, the last section [07 Actual Manufacturing Site of the Above Drug Product] they provide the name, address, and establishment registration number of the contractor.  With ordinary electronic database software, this information is easily cross-referenced and searched so that no necessary tracking information is ever lost.