In February 2025, the Food and Drug Administration (FDA) announced the shortage resolution for semaglutide injection products. Many of the stakeholder implications that accompany the FDA’s announcement of the resolution affect the community pharmacies, telehealth companies, and other providers managing patient care on the front lines. These stakeholders should assess their current practices and effectively transition during the brief window in which the FDA will employ enforcement discretion, or until April 22, 2025 for 503A pharmacies and until May 22, 2025 for 503B facilities.
Background
Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is available in the form of two FDA-approved injection products, Wegovy and Ozempic. The FDA initially added semaglutide injection products for Wegovy and Ozempic to its drug shortage list in March 2022 and August 2022, respectively, and now openly states the shortage has been “ongoing for some time.” The demand for semaglutide injection products in the United States exceeded the existing supply, and the resulting spur of activity we have seen by 503A compounding pharmacies and 503B outsourcing facilities since then has had an industry-wide impact.
503A compounding pharmacies compound drug products pursuant to a patient-specific prescription, while 503B outsourcing facilities generally compound drug products on a larger scale for office use at health facilities. Among other differences from FDA-approved drug products, compounded drug products have not undergone FDA premarket review for safety, effectiveness, or quality. Further, neither 503A compounding pharmacies nor 503B outsourcing facilities may compound a product that is “essentially a copy” of a commercially available drug (i.e., identical or nearly identical to an approved drug). One exception to this restriction is when the approved drug appears on the FDA’s shortage list at the time of compounding, distribution, and dispensing.
Shortage Resolution and Enforcement Discretion
The FDA has now confirmed that the manufacturer can meet both present and projected demands for semaglutide injection products in the United States. In its decision to deem the shortage resolved, the FDA considered the manufacturer’s production capabilities and existing inventory, in addition to wholesaler inventory. The FDA stated that it also considered information from “telehealth companies, pharmacy compounders, associations representing pharmacy compounders and outsourcing facilities, and individuals.”
In an attempt to avoid disruptions to patient treatment, the FDA intends to use its enforcement discretion over those persons or facilities compounding semaglutide injection products pursuant to Section 503A or 503B of the Food, Drug, and Cosmetic Act (FDCA), as follows:
| Person/Facility | Enforcement Discretion Period |
| State-licensed pharmacy or physician compounding under Section 503A of the FDCA | Compounding, distributing, or dispensing semaglutide injection products that are essentially a copy of an FDA-approved drug product permitted until April 22, 2025. |
| Outsourcing facilities under Section 503B of the FDCA | Compounding, distributing, or dispensing semaglutide injection products that are essentially a copy of an FDA-approved drug product permitted until May 22, 2025. |
While these periods of enforcement discretion are longer than the discretion period detailed in the FDA’s guidance for 503B outsourcing facilities (which is normally 60 days after the drug is removed from the FDA’s shortage list), the discretion periods for compounded semaglutide injection products mirror what we recently saw when the FDA deemed that the tirzepatide shortage was resolved. It is not unique to see the FDA provide a longer period of enforcement discretion for products compounded by 503B outsourcing facilities than those compounded by 503A compounding pharmacies because the FDA gives weight to the additional quality assurances and oversight that the FDA requires for 503B facilities.
It is worth emphasizing that these cut-off dates for compounding, distributing, or dispensing semaglutide injection products are for those compounded products that are essentially a copy of an FDA-approved product. The FDA’s declaratory order does not restrict compounders operating pursuant to Section 503A or 503B of the FDCA from compounding semaglutide injection products that are not essentially a copy of an FDA-approved drug and compounded to meet individual patient needs (e.g., different dose or inactive ingredients). Community pharmacies, telehealth companies, and other providers should be aware of the differences to avoid rejecting orders for permitted compounded products.
Strategic Planning: Pharmacies, Telehealth, Providers
While the implications of the semaglutide shortage resolution are more obvious for 503A compounding pharmacies and 503B outsourcing facilities, these aren’t the only stakeholders that will need to adapt following the FDA’s decision. Community pharmacies, telehealth companies, and other providers with a patient population relying on compounded semaglutide injection products will need to develop, and quickly begin executing, a transition plan. In its declaratory order, the FDA acknowledged that patients using these compounded products may face gaps in treatment and local shortages could persist. The FDA’s reasoning for extending the enforcement discretion period was in part to enable local pharmacies the opportunity to assess inventory and adjust ordering patterns based on new patterns of patient demand.
The window of “opportunity” that the FDA describes will not remain open long, and stakeholders prescribing, receiving, or dispensing compounded semaglutide injection products need to take immediate action to plan and adapt accordingly.
While a transition plan is highly specific to a given entity, Alston & Bird’s health care lawyers recommend that community pharmacies, telehealth companies, and other providers consider the following in their plans:
Ordering and dispensing stop dates
While ordering and receiving compounded semaglutide injection products from 503A compounding pharmacies and 503B outsourcing facilities is not an immediate concern, thanks to the FDA’s enforcement discretion periods of 60 and 90 days, respectively, providers receiving or dispensing these products will need to establish dates to cease doing so. While that decision will vary based on each company’s operations and supply chain, these providers should not be ordering, prescribing, or dispensing semaglutide injection products after April 22, 2025, if those products come from a 503A compounding pharmacy, or after May 22, 2025, if those products come from a 503B outsourcing facility.
Inventory management
We recommend stakeholders audit existing inventory levels for compounded semaglutide injection products, FDA-approved semaglutide injection products, and potential transition products that providers may prescribe to patients who were previously taking a compounded semaglutide injection product. Ensure your team knows the source for existing stock (503A pharmacy compounders or 503B outsourcing facilities) because of the different timelines for FDA enforcement discretion. Also, consider how your team will manage or dispose of existing stock of compounded semaglutide injection products that are not dispensed before the FDA enforcement date.
Coordinate with suppliers
Any stakeholder that is currently dispensing compounded semaglutide injection products should assess predicted product availability for FDA-approved semaglutide injection products. If you have a supplier point of contact, we recommend initiating a conversation with that person immediately. The anticipated transition to FDA-approved semaglutide injections will involve a large population of patients. Stakeholders should consider how they can diversify their supply chain (e.g., if a pharmacy has multiple wholesale distributor options).
Patient outreach and treatment transition plans
If your company prescribes or dispenses compounded semaglutide injection products, your team should develop a plan for patient and provider outreach. Don’t assume your patients or the health professionals within your chain are aware of the looming changes or deadlines. This plan should encompass patient education on the change and communications with prescribers and dispensers in your supply chain about product availability and prescription status.
Claims and insurance
Your team should anticipate insurance barriers such as prior authorizations. Inform your patients and providers about this likelihood. Also, use the transition period to assess how your claims will be submitted for billing to ensure services (e.g., telehealth services) meet the necessary requirements. Monitor claim and prescription denials and implement corrective actions if a trend is identified.
Policies, procedures, and training
Assess existing policies and procedures. Do your manuals, protocols, and checklists align with the forthcoming changes, including federal and state regulatory expectations? Educate your staff on the changes and train your teams on any procedure or policy changes your company is making. In addition, document the training and ensure your teams have a channel to ask questions if there is any uncertainty about the path forward.
Advertising and promotion
Audit your advertisements, webpages, social media, service and provider descriptions, and patient resources to be sure they comply with any internal policy or procedure changes and revised federal and state regulatory expectations. Consider conducting a user experience audit through the eyes of a patient who may be seeking products such as injections for weight loss.
Business plan
While the resolution of a drug shortage is not uncommon, the resolution of the semaglutide injection product shortage is accompanied by more implications than most products because of the tremendous increase in patient use in recent years, driven by recent expansions of telehealth and the availability of these products. The shortage has spurred compounding, prescribing, and dispensing activities, and the resulting reduction of those activities is not expected to be seamless.
Community pharmacies, telehealth companies, and other providers that now rely on the benefits connected to services such as compounding, prescribing, and dispensing semaglutide injection products may need to consider how to diversify their service and product portfolios. Impacted stakeholders that have not been planning for the shortage resolution will need to consider immediate and long-term solutions.
Conclusion
The resolution of the semaglutide injection product shortage will have an industry-wide ripple effect, shaping the practices of community pharmacies, telehealth companies, and other providers, and ultimately impacting the patients. While the future for compounding semaglutide injection products cannot be predicted with complete certainty, and lawsuits are already pending against the FDA following this announcement, we can say with confidence that navigating the transition for your practice and patients will require strategic planning.
Alston & Bird’s health care team is strategically poised to assist stakeholders navigating the transition period for semaglutide injection products, advising telehealth providers and others on updating business practices to stay in compliance and any future issues your team may face.
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If you have any questions, or would like additional information, please contact one of the attorneys on our FDA/Food, Drug & Device team or one of the attorneys on our Health Care team.