What Will DSCSA Enforcement Mean for Dispensers?
With just one month left until the FDA begins enforcing DSCSA for dispensers, some pharmacies and hospitals are still trying to understand exactly how the law will impact certain practices. Read the questions posed at our January 21 dispenser webinar, plus TraceLink experts’ answers.
Q: If I purchase medications for a physician’s office, who keeps the T3 documentation?
A: DSCSA compliance requirements focus on pharmacy dispensing operations, not on practitioners or clinicians that may use medications in their practice. That said, there are three primary scenarios to consider.
In the first, a doctor may have a practice with a steady flow of patients that require certain medications. That physician may work with a pharmacy, asking them to buy and stock the drugs that she knows her patients will regularly need. The pharmacy acquires the drugs on the
In the second scenario, the doctor may have her own pharmacy operation where she is purchasing drugs to fulfill her patients’ prescriptions. In that case, there is a change of ownership to her when she buys the drugs, and she must receive and store T3.
Finally, there is an exemption provision in DSCSA with respect to “office use”. A licensed practitioner who purchases minimal quantities of prescription drugs from a licensed retail pharmacy specifically for office use does not need to receive T3 compliance documentation for those products. This exemption is not meant to cover
Q: Should we refuse to sell drugs to another agency that cannot prove compliance with DSCSA requirements?
A: The general interpretation of DSCSA is that your organization’s liability extends only to you providing appropriate compliance documents for the products you sell to another agency. There is no clear provision within the law that says that as a seller, you have any responsibility to verify the compliance standing of whatever businesses purchase
While TraceLink cannot provide a legal opinion around this, we would suggest that your company assess the risk of selling drugs to a potentially questionable buyer. Such a buyer may increase the chances that your business becomes involved in a future suspect product investigation for
Q: Do paramedic services that are not owned by a hospital need to comply with DSCSA requirements for the drugs they purchase?
A: They may not need to comply with DSCSA. DSCSA includes a transaction exemption for the distribution of products for emergency medical reasons. The industry interpretation - led by several associations – is that drugs provided to emergency first responders, such as paramedic or ambulance services, should fall under this emergency medical exemption. Under this interpretation, companies supplying paramedic services would not need to provide T3 to those organization. Because of the diversity of operations that a paramedic service may perform, we encourage such a service to
Q: Who has to store the T3 in the very end?
A: Every company that buys or sells drugs in the supply chain needs to store a copy of the T3 they received or sent. So, DSCSA compliance requirements are a shared responsibility by everyone in the chain, not just the ultimate dispenser recipient of the drug product. The law stipulates that the compliance documentation must be retained for a period of at least 6 years. If
Q: I purchase most of my products from one major distributor. Do they keep records for drugs that they have sold to me?
A: Your wholesale distributors may offer you portal access for T3 documentation for the products which you have purchased through them and you may enter into a written agreement with them for such services, but you will want to question them about exactly what that means. Are they guaranteeing that they will store your data for the required 6 years? What are their guarantees around portal uptime? Can you be confident that you’ll be able to access T3 quickly in the event of a suspect product investigation or government inquiry? If you resell, borrow or loan drug products to another dispenser, will the wholesale portal provide that capability? And what happens to your T3 if you stop doing business with them?
If you are considering relying on supplier portal access, you may also want to evaluate the impact on your daily operations. If you work with multiple suppliers, your staff will be managing multiple portal logins and interfaces. And even if portal access feels manageable for your wholesaler partners, you still need a plan for drop shipments. How will manufacturers deliver T3 directly to you? Portal access may feel like a cost-effective compliance approach, but it introduces staff inefficiencies plus business risk.
Q: What are the DSCSA issues around medications that are compounded at our hospital infusion center or clinic?
A: Your hospital may buy commercially available drugs on the market and then compound them to create a special form of
Q: What are the T3 requirements for "Patient Assistance Medications"?
A: There is no explicit exemption in DSCSA for all scenarios under which Patient Assistance Program (PAP) products are distributed in the United States. There are certain exemptions in the law based on distribution through charitable (501(c)(3) organization or for product samples.
To date, the FDA has not provided specific guidance with respect to PAP products and DSCSA compliance.
Given statements by lawmakers during the formation of DSCSA, the general industry interpretation is that drug products provided under PAP were not intended to be subject to DSCSA regulations.
Q: If you have a hospital system with four separate pharmacies for each hospital, do you need to supply T3 if you are moving product between pharmacies?
A: As long as you are supplying product to pharmacies that are owned by one larger hospital system, then you do not have to provide T3. Your hospital system needs to have the compliance documentation for the products but you do not need to pass it onto your pharmacies that are all under common ownership. You may want to consider providing access to the documentation compliance repository to your pharmacies for situations like verification requests.
Q: We are a contract manufacturing organization (CMO). What are our responsibilities around T3?
A: Typically, a CMO that is simply performing manufacturing services on behalf of a brand owner has no DSCSA T3