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How is the pandemic response impacting the complex and evolving national traceability goals for pharmaceuticals?

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While DSCSA preparation has been quite the undertaking among pharmaceutical companies for the last several years, Tish Pahl, Principal at Olsson Frank Weeda Terman Matz PC, said the new elephant in the DSCSA room is the global pandemic. She spoke at HDA’s Distribution Management Webinar Series about how COVID-19 may affect some well-laid and long-standing plans.

COVID-19 is requiring a huge commitment from the FDA. Plus, “the same stressors we are all feeling in response to COVID-19 are also affecting the FDA,” she noted. “They're dealing with canceled schools and with having to work remotely and all of the pressures that are associated” with trying to work in this challenging environment. COVID-19 has complicated everything, including DSCSA [Drug Supply Chain Security Act] implementation. 

Still, Pahl explained, the FDA’s work on the DSCSA continues. The Agency is still currently underway with 20 DSCSA pilots with a variety of stakeholders.

Emergency drug exemptions

Tish Pahl, Principal at Olsson Frank Weeda Terman Matz PC.Tish Pahl, Principal at Olsson Frank Weeda Terman Matz PC.After Pahl spoke at the HDA webinar, the FDA released a guidance on exemptions and exclusions from DSCSA requirements during the COVID-19 public health emergency.

Pahl explained to Healthcare Packaging what the guidance means. The FDA guidance states that certain product distribution activities are exempt from the definition of “transaction” in the DSCSA, which means trading partners don’t have to exchange transaction data and the product does not have to be serialized. Other requirements, though, still apply, such as only doing business with authorized trading partners and having systems and processes for verification, including investigating and quarantining suspect and illegitimate product.

The guidance also states DSCSA requirements related to “wholesale distribution” do not apply to distribution activities that address the COVID-19 public health emergency. However, the FDA states it doesn’t interpret this exclusion from wholesale distribution to affect the ability of States to require licensure of trading partners as wholesale distributors under State law.

The guidance also describes what products are included in this exemption and exclusion.

  • Covered products include products that are under an emergency use authorization (EUA) or are approved by the FDA for COVID-19 prevention or treatment.
  • It also covers distribution of other products affected by the COVID-19 public health emergency, such as distribution of product to a high demand area where the product is in shortage and distribution to an authorized trading partner’s temporary facility.
  • Dispenser-to-dispenser transfers that are needed for COVID-19 care are also covered.

But Pahl noted that her caution from the webinar is still true. How does a distributor know what product is for a public health emergency? It’s probably fair to assume fentanyl going to a hospital in New York is going to help a patient on a ventilator. But to what extent, if at all, do you treat these products differently? Their sale may be exempt from DSCSA transaction requirements, but sometimes exceptions are more trouble than they’re worth. The option is there to take them out of DSCSA requirements if it makes sense for your logistics or business perspective.

Recall draft guidance

Pahl reminded attendees that the FDA recall draft guidance is not a legal requirement. It applies to all FDA regulated products—drugs, OTC, prescriptions, devices, etc.—and lays out FDA’s expectations to maintain records to implement a recall. The assumption could be implied from the guidance that the FDA is expecting unit-level traceability for prescription drugs now, but the DSCSA does not currently require that. (Because of the sequential milestones, trading partners won’t have the ability to trace an item through the supply chain until 2023.)

Products from the strategic stockpile

The FDA DSCSA guidance issued in April 2020 is relevant to distributions from the strategic national stockpile. These products are for COVID-19 treatment and so the transactions would be exempt from the DSCSA and their sale would not be “wholesale distribution."

But Pahl drew attention to the EUA issued Mar. 28, 2020 for chloroquine phosphate and hydroxychloroquine sulfate. The EUA makes these drugs available via the strategic stockpile for patients who can't participate in a clinical trial. This EUA states that the strategic stockpile will maintain records regarding distribution of these drugs under its direction, and that those distribution records include lot numbers, quantity, receiving site, and receipt date. She advised that if you’re involved in the distribution of those drugs out of the stockpile, you should pay attention to this language. The DSCSA definition of “transaction” does not apply but the EUA is requiring maintenance of lot-level transaction data.

What’s affected by COVID-19?

With the increased difficulty in getting things done, certain activities are more likely to be upended or deferred. Pahl noted that the FDA is dealing with the reassignment of a lot of the uniformed public health service corps for pandemic response.

  • Inspections: FDA says that they are postponing domestic inspections unless they’re mission critical. DSCSA-related audits and inspections will not be taking place unless they’re related to COVID-19 or are for a specific, “mission critical” cause.
  • Deadlines: While no announcements have been made, it's likely the industry will see some DSCSA deadline extensions and more enforcement discretion.
  • Licensing standards: The FDA has not yet issued licensing standards for wholesale distributors and 3PLS.
  • Reporting of theft: The Agency stated they expected to provide further guidance on theft, but with the response to COVID-19, it’s unlikely we’ll see it anytime soon.
  • Guidance on serial number exchange: Pahl was asked about whether there were any discussions taking place with the FDA regarding how serial numbers should be exchanged after Nov. 27, 2023, including specific file formats such as EDI, EPCIS or XML. Pahl said the closest the Agency has come was to state that EPCIS and ASN were appropriate means for the exchange of electronic transaction data. They haven't gone any further than that—that she knows of—but it’s a really important question and, were it not for COVID-19, trading partners would be starting discussions with the FDA about these types of 2023 implementation issues.
  • CDER guidance: These guidances/revisions were on the 2020 agenda, but may be deferred:
    • Definitions of Suspect Product Revised Guidance under the Drug Supply Chain Security Act.
    • Identifying Trading Partners under the Drug Supply Chain Security Act; Revised Guidance.
    • Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Revised Guidance.

OIG report

Pahl noted that the HHS Office of Inspector General (OIG) released its third DSCSA report in Feb. 2020. Overall it was positive (37 of 44 selected drug products could be traced) with two areas for possible concern.

  • OIG, with FDA concurrence, is very interested not just in changes of ownership of product but also changes in product possession and location (which the DSCSA doesn't require).
  • Pahl said the OIG wants to see information that is embedded within master data in transaction information. Strength, package size and more might not be in the TI that's provided because it's embedded within master data, and it doesn’t seem that the OIG understands this. OIG has raised this issue in previous reports and this could come up in the future.

Dispenser requirements

Heightened suspect product investigation requirements go into effect on Nov. 27, 2020 and are causing a lot of concern for dispensers. There's a requirement that they verify the lot number of suspect product and that the verification process include three packages or 10% of the suspect product in inventory, whichever is greater. Small independent pharmacies may be able to do this without too much disruption, but it’s not straightforward for national chains with hundreds of dispensing locations. Pahl advised dispensers not to panic and to talk to trading partners about the implementation of these requirements: “You need to have your SOPs in place, train on them, follow them, and make sure that you can follow them.”

As of Nov. 27, 2023, dispensers can only transact with product that has an identifier. Pahl said this is a good opportunity to revisit the grandfathering policy (Sep. 2018) that says that a product packaged or repackaged before Nov. 27, 2018 doesn't need an identifier. While the absence of a product identifier can be an indicator of a suspect product, the guidance says “absent other indicia that a product may be suspect or illegitimate, the [transaction statement or TS] is one indication that the product was in the pharmaceutical distribution supply chain before” Nov. 27, 2018. 

Also, be alert to attempts to expand obligations beyond what the DSCSA requires now, including item-level tracing based on the product identifier. Talk to trade associations about whether or not you need help, including enforcement discretion and extensions of time. 

Closing advice

Pahl offered the following reminder in this COVID-19 environment: “Do document what you're doing if it departs from the DSCSA, because it's entirely likely that in two years an inspector will come back and say, ‘Hey, why don't you have transaction data for these transactions?’ And the response is, ‘Well, it was part of coronavirus and memories are short.’ If you're departing from your normal compliant practices,  be certain to document that.”

For the latest in track-and-trace and brand protection technology, make plans to visit PACK EXPO International in Chicago, November 8-11, 2020.

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