Any stakeholders, including pharmacies, distributors and manufacturers, who are not ready to comply with the Drug Supply Chain Security Act (DSCSA) need to start preparing their requests for waivers, exceptions and exemptions (WEEs). Facilities that execute these documents poorly will be at risk for being held noncompliant by the FDA, state boards of pharmacy and other regulators charged with ensuring U.S. product safety and integrity, experts noted during the 2024 Traceability Seminar, held in Washington, D.C.
The looming Nov. 27 go-live date for DSCSA is not something to be taken lightly. After a one-year stabilization period, the FDA said it will not postpone enforcement of the act, Tish E. Pahl, JD, an attorney specializing in FDA-related issues at Olsson Frank Weeda Terman Matz PC, told attendees of the meeting, which was hosted by the Healthcare Distribution Alliance (HDA). That’s why it is so important to begin the WEE filing process, Ms. Tish stressed. She added that although the initial Aug. 1 deadline for filing WEEs has passed, the FDA will still accept them, but there is no guarantee the agency will respond before the November go-live date.
According to Ms. Pahl, a WEE request should explain:
- the DSCSA requirements that cannot be met;
- what has been done so far to comply;
- why more time is needed;
- how current supply chain security protections will be maintained; and
- why the request will not place added burdens on downstream trading partners.
While the FDA is considering a WEE request, the obligations of trading partners are not excused, she warned.
Although the DSCSA seems onerous in many respects, “it is all about getting product through to the patient in the safest and most efficient way possible,” said Elizabeth Gallenagh, general counsel and the senior vice president of supply chain integrity at the HDA. Communication among trading partners is essential but remains a challenge, Ms. Gallenagh explained, given their often siloed positions in the supply chain. She added that “this is a complex system and something that we have never done before.” Thus, “issues will arise even beyond the DSCSA implementation and deadline.”
As for DSCSA enforcement, the FDA is first likely to target bad actors who knowingly violate the DSCSA by, for example, selling counterfeit goods, said Brian P. Waldman, JD, a partner in the Food & Drug Group at ArentFox Schiff LLP.
If a company is concerned about not being able to comply with the DSCSA’s enhanced requirements by Nov. 27 and concludes it must file a WEE request, “you put yourself in a better position to secure the WEE if you explain in your request all that you have done already, what you haven’t done yet but are planning to do and how you will keep the supply chain safe in the interval until you reach full compliance,” Mr. Waldman said. (See box for other exemptions.)
All three presenters referenced the FDA’s guidance documents, available online (bit.ly/3MDWbOP). “Read the documents word for word, and pay attention; some of your questions will be answered, and if not, you can articulate a more nuanced question that the FDA may respond to,” he said.
How to Ace Your FDA Inspection
At some point, all facilities will be subject to DSCSA-related FDA inspections. “Be prepared” and “practice makes perfect” are important tenets when the FDA comes calling, according to Jeb Hunter, BS, a senior regulatory consultant at EAS Consulting Group.
At its core, the FDA has a mission to protect public health, he explained, which is why FDA inspections are important. “The simple act of having a process or procedure in place and following it is a great tool for compliance,” he said. However, mock inspections to practice the procedures, with everyone knowing their roles, are essential, he emphasized.
The Investigations Operations Manual (IOM) is the FDA’s main policy guide for investigators and others conducting inspections, according to Mr. Hunter. The IOM is available online (bit.ly/t4ehRcPs) to help industries understand operations and be prepared, he said.
Preparing for an FDA inspection should start with some essential standard operating procedures, including the initial receipt of the investigators and notification of facility personnel of their arrival, Mr. Hunter said. Make sure the most senior individual is identified and present. Have a preexisting slideshow ready (about 15-20 minutes) that outlines the facility and flow of materials. Make sure the slide presentation mirrors what the inspector sees while walking the floor, he said.
“Accompany your inspector or auditor at all times,” he added, and provide them with a product catalog and copy of the slide presentation so the inspectors can follow along and take notes.
Plan for and designate the appropriate personnel for different tasks so everyone knows what role they will play when an inspector arrives. Decide who will host, lead the facility tour, provide subject-specific expertise and act as scribes/notetakers (one per investigator), Mr. Hunter said. He also recommended the creation of a backroom command center, with a designated leader and support staff. Be sure this room is located away from the audit room where the opening and closing inspection meetings occur, he added. Assign runners to take any documents requested by the inspectors from the back room. Review all documents before they go to the inspectors, and make copies of everything given to them, he said.
Be prepared if an FDA inspector decides to take photos, even if the facility has a policy against it, he said. “If they take a picture, you take the exact same picture, and treat it like a sample so you know exactly what they saw at the exact same time.”
Mr. Hunter also offered a plan to manage affidavits that may occur during an inspection. If an inspector begins to read an affidavit aloud, he advised that the entire facility team stand up and leave the room. “It is going to be the most uncomfortable thing you have ever done, but hearing an affidavit can be just as legally binding as signing it,” he said. “I also recommend consulting with your legal team prior to implementing this practice, as well as having your legal team on call for instances like this, should they occur,” he added.
Regularly review these and other aspects of the inspection process, Mr. Hunter recommended. With a mindset to “be audit-ready every day” and a practiced plan in place, an FDA inspection can be a success, he said.
State Boards Play a Role
The FDA is not the only regulatory agency stakeholders need to heed. At the pharmacy level, DSCSA inspection will be rolled into existing state boards of pharmacy inspections, according to Josh Bolin, the associate executive director for government affairs and innovation for the National Association of Boards of Pharmacy (NABP).
NABP is developing a Dispenser Guide to Achieving DSCSA Compliance. To obtain the document, sign up for the NABP mailing list at www.pulse.pharmacy.
The HDA is doing its part by suggesting that regulators take a measured approach to DSCSA enforcement. Specifically, the group sent the FDA a letter on Aug. 19 calling for a phased, stepwise rollout (bit.ly/3XdISuH). In the letter, the HDA also encouraged the agency to swiftly approve WEEs to mitigate supply chain disruption and asked for weekly “rapid response” calls with industry stakeholders to smooth the transition.
At press-time, an HDA spokesperson said the group has remained engaged with the FDA since sending the letter on Aug. 19, and was slated to further discuss its contents with the agency in late September.
The sources reported no relevant financial disclosures beyond their stated employment.
This article is from the October 2024 print issue.