The question, “What is a drug pedigree?” is easily answered because the FDA itself has given us the definition: “A drug pedigree is 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.” To that we may add that there is also something called an e-pedigree, which is simply a pedigree in electronic form – that is, an electronic document that satisfies a pedigree requirement. The second question: “What difference does DSCSA make?” requires more discussion.
Before DSCSA came into force, the relevant legislation was the Prescription Drug Marketing Act of 1987 as amended in 1992 which placed pedigree requirements in 21 CFR Part 203. Every person engaged in the wholesale distribution of a prescription drug in interstate commerce who was not the manufacturer or an authorised distributor of record for that drug had to provide to the person who received the drug the pedigree for that drug. An authorised distributor of record was defined as “a distributor that has an ongoing relationship with a manufacturer to distribute that manufacturer’s drug products.” What qualified as an “ongoing relationship” was not at that time defined, but in 1999 FDA published regulations defining “ongoing relationship” to include a written agreement between manufacturer and distributor. The 1999 regulations also specified the fields of information that had to be included in the drug pedigree and stated that the information in the pedigree should be traceable back to the first sale by the manufacturer.
FDA did not seek to enforce the pedigree-related requirements in every case. In a guidance note, they set out the factors they would take into account in deciding whether enforcement measures were necessary.
These were as follows:
High Value in the US Market
FDA felt that experience showed that drug products with a high market value, high price or high sales volume or of which there was a shortage were more frequently counterfeited or stolen than others.
Prior Indicators
FDA finds that the same drugs are counterfeited or stolen again and again. In most cases, pedigrees are either falsified or not provided and this is an area where enforcement is almost automatic.
Reasonable Probability
In the case of new drugs that don’t have enough marketing history to qualify under the first two factors, FDA will take account of the reasonable probability that they may be earmarked for counterfeiting or diversion.
It should be stressed that these were the most frequent causes of enforcement but they were not the only ones; FDA also had a policy of taking action against wholesale distributors and others involved in the manufacture or distribution of counterfeit drugs and the type of drug involved would not enter into the calculation.
Passage of the DSCSA took us away from the previous regulatory environment and into a new one. The present regime is to be understood in relation to the requirement of the DSCSA that pharmaceutical manufacturers, repackagers, wholesale distributors, and drug dispensers who are not practitioners should notify FDA and certain trading partners of products identified as illegitimate within 24 hours of that determination being made. Products not so identified but suspect have to be quarantined while an investigation is conducted.
Trading partners have had to develop secure electronic systems to ensure that these requirements can be met. The idea of the drug pedigree is now expanded to embrace the set of documentation laid down in the Act. We are speaking here not of Master Data but of Transactional or Instance Data, of which the most relevant example is the lot number attached to a specific batch at the factory and following it all the way to the point at which it is broken down for distribution to consumers. The data must not change at any point on the chain.
We should, then, think of the pedigree in DSCSA terms as the DSCSA Transaction History, Information and Statement or T3. What we now have is a specific form for the Drug Pedigree – but not, as yet, a specific format. That is something that is being hammered out in discussions between all stakeholders at the present time and those stakeholders (they know who they are) who are not taking an active part in these discussions will have to accept what the active majority decides they should have.
We have said this on this blog before in relation to pharmacists; in fact, it applies to everyone on the supply chain from manufacturer onwards. It will be essential, if only to protect themselves against FDA enforcement, that every party involved at every stage of drug distribution from beginning to end should ensure that every T3 that passes through their hands is correct for the product it purports to cover and contains the data elements that FDA through DSCSA has decreed that it should contain.
Finally, and for the avoidance of doubt, here are the items that MUST be included in the new-style drug pedigree:
- The name of the drug (both proprietary and established);
- Dosage;
- Container size;
- Number of containers;
- The lot number(s);
- The business name and address of all parties to each prior transaction involving the drug, starting with the manufacturer; and
- The date of each previous transaction
Free DSCSA Evaluation
Contact TrackTraceRx today to receive a free evaluation of your DSCSA current policy and procedures. This free consultation will allow you to have a piece of mind that you are following the correct procedures in order to meet ALL DSCSA requirements. TrackTraceRx will also provide you with a FREE Standard Operating Procedure (SOP) template which is required by the DSCSA during a FDA inspection.
COMMENTS