Hello all…
As you may have already heard, the FDA has announced more exemptions for authorized trading partners. For this post I will focus on the newly announced exemptions for dispensers that are not covered under the already established exemption for “small dispensers” (i.e., small dispensers are to use the previously announced exemption.). The link to the FDA document can be found here:
This is basic information from exemption:
“The exemptions apply to any product transacted by eligible trading partners who have initiated their systems and processes, as described in section 582(g)(1) of the FD&C Act, including electronic DSCSA data connections (which may include portals) with their immediate trading partners by November 27, 2024, and extend to trading partners throughout the pharmaceutical distribution supply chain who subsequently transact such product. For the purposes of these exemptions, eligible trading partners are those who have initiated their systems and processes by successfully completing data connections with their immediate trading partners and those who initiated processes including documentation of efforts to establish data connections but were not able to fully complete them with all immediate trading partners.
If trading partners do not need to rely on the exemptions in this document, the exemption for Small Business Dispensers issued by FDA on July 12, 20245, or any other previously established DSCSA exemption, we advise them to exchange electronic DSCSA transaction information and transaction statements and meet all other requirements of section 582(g)(1) of the FD&C Act beginning November 27, 2024. The exemptions described in this document do not apply to other requirements in section 582 of the FD&C Act. Trading partners who rely on the exemptions described in this document do not need to submit a notification or request for a waiver or exemption to FDA.”
Note that the exemption is only available if you have initiated electronic data connections for DSCSA. The FDA is also stating that this includes the use of portals as your electronic data connection. As you are most likely aware, if you are not using a third-party solution to retrieve your EPCIS data from your suppliers (i.e., the electronic data connection), then you can use the web portals of the trading partner to save your transaction data. You MUST have an agreement in place for the storage of data to occur!
These are the exemptions (i.e., are being delayed for full compliance until November 27, 2025):
Exemption related to verification requirements that include at least 3 packages or 10 percent of suspect products. If fewer than 3 then all items must be verified. ALSO….This exemption is for “responding to a notification” of possible illegitimate product from FDA or other trading partner. NOTE: You must meet all other requirements noted within 582(d)4.
I recommend that, if you are able to complete the verification process, you should do it even if you are in the exemption phase. Personally, I think all of you should be able to verify with the manufacturer if/when there is a suspect product (i.e., call the manufacturer and compare the product identifier information (i.e., lot#, Exp#, Serial number, and NDC or GTIN) with what the manufacturer has on their records. At a minimum you should do the quantities noted above.
If you receive notification from FDA for communication, you still need to complete the process they are requesting.
Electronic interoperability is not fully required at this time…i.e., if your supplier is sending transaction information on paper, you can still receive that and store that information for 6 years as required.
If you receive transaction information that does not include all information including full product identifier information (i.e., lot#, Exp#, Serial number, and NDC or GTIN) noted on the 2D barcode it is ok to continue to receive and use the product.
Verification process is still required BUT if standardized numerical identifier (i.e., a combination of the serial number and NDC) is not available you can still continue to use the current practice you are using to verify. Again, as noted in #1 above, you should be able to complete this process as basically all products you receive have the 2D barcodes with all the information needed in order to complete a verification process.
An exemption related to the requirement under section 582(g)(1)(D) of the FD&C Act for systems and processes necessary to promptly respond with the transaction information and transaction statement for a product upon a request by the Secretary, or other appropriate Federal or State official, in the event of a recall or for the purposes of investigating a suspect product or an illegitimate product. Eligible dispensers and their trading partners may continue to rely on current methods to respond to such requests for such information.
Request for information from FDA can be responded to and uploaded to the CDER NextGen Portal. I recommend this process to respond when called upon by the FDA. This is the link to CDER NextGen portal: https://cdernextgenportal.fda.gov/Login_CDER?ec=302&startURL=%2Fs%2F --- Some of you already have access to this portal. If you don’t, I recommend going ahead and creating a log in.
For States, work with your state and follow their request of how to respond.
Other trading partners --- as you are aware, we recommend that you only sell products to other dispensers if it is patient specific or buy products if it is patient specific—No borrow/loan which would require exchange of transaction information. Remember common ownership of dispensers allows for transfer of products too without the need to transfer transaction information.
The requirement under section 582(g)(1)(E) of the FD&C Act for systems and processes necessary to promptly facilitate gathering the information necessary to produce the transaction information for each transaction going back to the manufacturer, as applicable (i) in the event of a request by the Secretary, or other appropriate Federal or State official, on account of a recall or for the purposes of investigating a suspect product or an illegitimate product; or (ii) in the event of a request by an authorized trading partner, in a secure manner that ensures the protection of confidential commercial information and trade secrets, for purposes of investigating a suspect product or assisting the Secretary, or other appropriate Federal or State official, with a request. Eligible dispensers and their trading partners may use current methods to respond to such requests, for products transacted by eligible dispensers from November 27, 2024, until November 27, 2025, with the relevant transaction information if they directly transacted the product(s) subject to the request.
See #5 a, b, and c above regarding communications.
There is an exemption for full compliance related to “saleable returns.” Most likely you are not going to be supplying products to other dispensers, but, if you are, you can continue to use your regular process. Your wholesaler has an allowance from this document that will allow them to use their regular process until August 27, 2025. You have until November 27, 2025 per this document. After November 27, 2025, they must start the “saleable returns” verification process. You may see this process start earlier as they are able to go online.
Two notes by the FDA in this exemption document:
As a condition of the exemptions from certain DSCSA requirements described in this document, the FDA expects eligible trading partners to communicate their reliance on the exemptions to their trading partners and that such exemptions, where applicable, also extend to transactions of product with trading partners. Such notification should occur through a readily accessible resource or communication and should also provide a mechanism by which trading partners can confirm the applicability of the exemptions.
You should ensure that the ATPs you work with are informed of your exemption as well as they should be informing you of theirs (i.e., let your wholesaler know you are under the exemption, let manufacturers you purchase from know, etc.)
The exemptions described in this document are not intended to provide, and should not be viewed as providing, a justification for delaying efforts to implement the enhanced drug distribution security requirements in section 582(g)(1) of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.
i.e.,…..YOU MUST MOVE FORWARD TO FULL COMPLIANCE!
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