The 19th Annual 340B Coalition Conference in Washington DC has come to an end. The Drug Track IQ team had a great time and would like to thank 340B Health (previously known and SNPHA) for putting on a great conference. I would definitely recommend attending a 340B Coalition meeting if you ever have the opportunity. This was the first time that I have been to this conference and I feel like I learned a lot more about 340B in general as well as how the new Drug Supply Chain Security Act (DSCSA) aka Track and Trace may have an impact on covered entities and contract pharmacies and the way they do business. Specifically during a session focused on the Key Elements of 340B Contract Pharmacy Arrangements both Greg Doggett who is counsel at the Legal and Policy Affairs at 340B health and Jason Atlas with Apexus brought up issue pertaining the DSCSA.
Greg started with the provision that dispenses cannot accept ownership of a product unless it gets the transaction information or 3Ts from the products previous owner. The statute does not specifically mention or give exemption to contact pharmacies who operate under the bill to ship to arrangement. The wholesalers may send transaction information to the covered entity or send it to the contract pharmacy with only the covered entity as the new owner. Either way the contract pharmacy may have a problem accepting the products as they are not in the transaction documents. 340B Health has requested an exemption from the FDA for the contract pharmacies but the FDA has yet to release any guidance.
Next up Jason gave a great overview of the Cloud Based Service Providers. Cloud based providers are able to store transaction data from a variety of sources and data feeds including EDI connections, paper records, and other file types. Jason’s take home points include that most vendors charge from $10,000 to $100,000 per year along with monthly service fees, implementation could take up to 8 weeks, and they may not meet the possible requirement for contract pharmacies to have access to transactions and be listed as a trading partner.
Drug Track IQ is a cloud based provider who is also able to use a variety of sources for the transaction data including EDI and paper and since we have partnered with TurnKey Pharmacy Solutions we understan
d the unique relationship between covered entities and contract pharmacies. We have created a unique way to add the contract pharmacies to the transaction documents so they can remain compliant with the laws and regulations whether the FDA gives an exemption or not and we definitely are not as expensive as some of the competition. If you want to hear more please contact us.