Physicians who mix allergy immunotherapy injections in their offices must still comply with USP 797 standards to remain in full compliance with state and federal regulations. These pharmaceutical compounding guidelines, established by the United States Pharmacopeia (USP), ensure patient safety by minimizing risks of contamination, incorrect dosing, or other errors during sterile preparation.
Recent confusion stemming from CMS commentary
Misunderstandings have surfaced recently due to a single sentence in CMS’s explanation accompanying the 2026 Medicare Physician Fee Schedule (MPFS). In justifying their decision not to increase reimbursement rates for venom immunotherapy, CMS included language that some interpreted as a relaxation or waiver of USP 797 requirements.
To clarify:
- CMS lacks authority to waive USP 797 permanently – USP 797 is a federally recognized standard enforced through state boards of pharmacy, the FDA, and other regulatory bodies. Only Congress can enact permanent changes or waivers to these standards. CMS, as an administrative agency, can issue temporary guidance or enforcement discretion in limited circumstances but cannot override the core requirements.
- Improper venue for policy announcements – Even if CMS had the power to alter USP 797, they would not announce such a significant regulatory shift in a brief aside within the MPFS. Major changes require formal rulemaking processes, including public notice, comment periods, and publication in the Federal Register. A casual reference in a payment policy document does not constitute official guidance.
The College views this CMS statement as an error and will formally write to the agency to request a correction and clarification. We will keep members updated on any response.
Beware of aggressive third-party compliance vendors
The College has received multiple reports from members about third-party companies aggressively marketing USP 797 compliance services. These vendors often:
- Contact practices directly, offering “turnkey” solutions for a base fee.
- Perform an on-site audit and declare the office non-compliant (sometimes citing minor or debatable issues).
- Demand additional high fees for “required” add-on services, equipment, or ongoing consultations.
- Imply – subtly or overtly – that failure to pay could result in reports to regulatory authorities, creating undue pressure.
While some vendors provide legitimate value, others exploit fear and confusion for profit. Non-compliance can indeed lead to serious consequences, including fines, licensure issues, or patient harm – but scare tactics are not ethical.
Recommendations for members
- Prioritize direct compliance efforts. Adhere to USP 797 as the safest and most reliable path. The College offers free, comprehensive resources on our website, including:
- Step-by-step compliance checklists
- Training modules and webinars
- Sample policies, documentation templates, and environmental monitoring guides
- Access our Allergen Extract Mixing Toolkit for a complete USP compliance guide – everything you need to know about the rule and how to stay compliant. (members-only login required for full toolkit).
- Vet vendors thoroughly. If you choose to engage external help:
- Request references specifically from other ACAAI member allergists.
- Ask for a detailed scope of services, itemized pricing, and a written guarantee against “surprise” fees.
- Consult your state pharmacy board or legal counsel before signing contracts.
Patient safety remains our top priority. By following USP 797 proactively – whether independently or with trusted support – you protect your patients, your practice, and your professional standing.
Questions? Contact the ACAAI Practice Management Team.
The Advocacy Council – ADVOCATING FOR ALLERGISTS AND THEIR PATIENTS.
