By SiriusRx|Education for practices

Clinical review pending. This article has not yet been reviewed by a licensed clinician, and we would rather say so than print a name that does not exist.

Wellness and functional medicine practices already know how to run a cash-pay program. Adding therapies from a pharmacy that compounds brings a different set of obligations: ingredient eligibility, pharmacy vetting, in-office handling rules, advertising limits, and safety reporting. The practices that do this well treat readiness as a project with an owner and a finish line.

Use this checklist with your medical director and practice manager. It is general education, not legal advice, and it names no products.

1. Who owns the service line

The practice, not a vendor, owns the clinical decisions. A workable file usually includes:

  • A named medical director who approves which therapies the practice offers.
  • Written reference materials the practice adapts under its own clinical judgment. They are not standing orders.
  • A written scope for each role: who evaluates, who prescribes, who administers, and who follows up, consistent with Virginia law and regulations and the practice's supervision and delegation arrangements.
  • A file for each therapy the practice offers, refreshed when the rules change.

2. Legal status of each therapy

  • For each therapy, a written note of which pathway applies (503A, 503B, or neither), checked against FDA's current bulk-substance lists and interim categories.
  • A rule that nothing is offered, or mentioned to patients, until that basis is documented.
  • A calendar reminder to recheck status at least quarterly, and whenever FDA publishes a relevant policy.

3. Pharmacy relationships

  • At least one vetted pharmacy for each therapy, with license, inspection history, and lot testing reviewed and filed.
  • Patient choice preserved and documented. Patients may use any licensed pharmacy.
  • No payments, rebates, free goods, or discounts from any pharmacy or manufacturer tied to prescribing.

4. In-office handling

  • A written decision on which path the practice uses: the patient handles it at home, the office uses a patient-specific prescription, or office stock comes from an eligible 503B source.
  • The Virginia Board of Pharmacy permit, license, or registration the path requires (Va. Code 54.1-3420.2), plus the written pharmacy contract Virginia requires for delivery to a practitioner's office (18VAC110-20-275).
  • Storage, labeling, and chain-of-custody steps, including cold storage where the label requires it.

See in-office administration in Virginia.

5. Consent and documentation

  • Consent forms that state plainly that drugs a pharmacy compounds are not FDA-approved.
  • Charting templates that capture the evaluation, the reason for the prescription, follow-up, and, where the drug is close to a commercially available one, the prescriber's determination of a significant difference for that patient.
  • Records retention for Board of Medicine licensees: at least six years after the last patient encounter, with longer periods for minors and where other law or a contract requires it (18VAC85-20-26).

6. Advertising and patient materials

  • A claims review step before any ad, web page, or handout is used.
  • A substantiation file for every advertising claim. Virginia's Board of Medicine requires documentation supporting advertising claims to be kept and available for the board's review for at least two years (18VAC85-20-30). Federal advertising law also requires a reasonable basis before a claim runs.
  • No statement that a drug a pharmacy compounds is approved, equivalent to an approved drug, or superior to one. No promised results, and no "available now" language for a therapy without a documented pathway.

See advertising rules for practices.

7. Safety and quality incidents

  • A same-day process for reporting a suspected adverse event to the dispensing pharmacy, and guidance for filing a voluntary report with FDA MedWatch.
  • A recall procedure: how you learn of a recall, how you find affected patients, and who calls them.
  • A mock recall before launch.

8. Staff training

  • Every staff member who talks with patients completes training on the service line, the scripts for common questions, and what they must not say.
  • Training records stay on file. A completion record shows course completion only. It does not expand anyone's scope of practice.

See staff training for a new service line.

9. Insurance and contracts

  • Confirm that malpractice and general liability coverage extends to the new service line.
  • Have counsel review any vendor, pharmacy, or program agreement before signing.

Where the work usually takes longest

The items above are simple to list and slow to finish. Pharmacy vetting, in-office permits, and advertising substantiation depend on outside parties, so they tend to take longest. Start those first.

How SiriusRx helps

The SiriusRx Peptide Program is built around this checklist: reference materials the practice adapts, consent and charting templates, a pharmacy vetting framework, information on independent partner pharmacies, an advertising kit with a substantiation file, adverse event and recall workflows, and staff training. SiriusRx does not take payment from a pharmacy or a drug manufacturer.

General education, not legal advice.

Sources

  • FD&C Act section 503A, 21 U.S.C. 353a: https://www.law.cornell.edu/uscode/text/21/353a.
  • FD&C Act section 503B, 21 U.S.C. 353b: https://www.law.cornell.edu/uscode/text/21/353b.
  • FDA, bulk drug substances under section 503A of the FD&C Act.
  • FDA, Compounding and the FDA: Questions and Answers: https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers.
  • FDA guidance for industry (January 2018) on essentially copies of a commercially available drug product under section 503A: https://www.fda.gov/media/98973/download.
  • Va. Code 54.1-3420.2, Delivery of prescription drug order: https://law.lis.virginia.gov/vacode/title54.1/chapter34/section54.1-3420.2/.
  • 18VAC110-20-275, delivery of dispensed prescriptions (Virginia Board of Pharmacy): https://law.lis.virginia.gov/admincode/title18/agency110/chapter20/section275/.
  • 18VAC85-20-26, Patient records (Virginia Board of Medicine): https://law.lis.virginia.gov/admincode/title18/agency85/chapter20/section26/.
  • 18VAC85-20-30, Advertising ethics (Virginia Board of Medicine): https://law.lis.virginia.gov/admincode/title18/agency85/chapter20/section30/.
  • FTC, Health Products Compliance Guidance (December 2022): https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance.
  • FDA MedWatch, the FDA safety information and adverse event reporting program: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

For practices

Contact us.

This is education for licensed practices. It is not legal, medical, or pharmacy advice, and it does not tell a practice what to prescribe. Contact us with questions about the program.