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.

Many practices, especially med spas, want to administer in the office rather than send a patient home with a prescription. Virginia allows some paths and not others. Each path has its own requirements. Using the wrong path can expose a clinic to action by a state board of pharmacy.

This is general education for Virginia practices, not legal advice. It names no products. Read the statutes with counsel before a launch.

Path A: the patient administers at home

The pharmacy dispenses the prescription to the patient, who uses it at home as directed.

  • The patient chooses the pharmacy.
  • The practice teaches technique, storage, and what to report, and documents that teaching.
  • A Virginia pharmacy may not deliver a prescription to a patient's home when the patient will carry it to a practitioner's office for administration and it requires special storage, or has to be mixed before use (18VAC110-20-275 G). Use Path B for those.

Path B: the office administers a patient-specific prescription

A 503A pharmacy compounds the patient's own prescription and delivers it to the practice, where the team administers it.

  • In Virginia, a prescription drug delivered somewhere other than the patient or the patient's home generally must go to a location that holds a Board of Pharmacy permit, license, or registration authorizing possession of controlled substances (Va. Code 54.1-3420.2). In Virginia, Schedule VI covers these prescription drugs (Va. Code 54.1-3455). Confirm the office holds the right one.
  • Delivery to a practitioner's office for administration requires a written contract between the pharmacy and the practitioner (18VAC110-20-275 C).
  • The container is labeled for one patient and used only for that patient.
  • Track receipt, storage, use, and disposal for that patient's prescription.

Path C: office stock from a 503B outsourcing facility

A registered 503B outsourcing facility supplies the practice for office use, without a patient-specific prescription.

  • Only substances eligible under FDA's 503B policy can be supplied this way. Many substances a 503A pharmacy can prepare for a named patient have no 503B path.
  • Confirm the facility appears on FDA's list of registered outsourcing facilities and holds a Virginia permit if it is in the state, or a Virginia registration if it is not (Va. Code 54.1-3434.05 and Va. Code 54.1-3434.5).
  • Keep lot records so the practice can act on a recall.

What is not a path: routine office stock from a 503A pharmacy

A 503A pharmacy compounds for identified patients. Virginia allows a pharmacist to provide a reasonable amount to a practitioner of medicine, osteopathy, podiatry, or dentistry for office administration only for a critical need to treat an emergency, or as federal law allows, with special labeling (Va. Code 54.1-3410.2). FDA's prescription-requirement guidance under section 503A points practices that need office stock toward a 503B outsourcing facility. Read together, these are not permission for routine office stock from a 503A pharmacy. Be wary of any supplier that suggests otherwise.

Who may administer

Who may evaluate, supervise, and administer injections is set by Virginia law and regulations and by the practice's supervision and delegation arrangements, not by a vendor training certificate. Confirm each role with counsel before launch. Med spa supervision is a question for that review.

A quick self-check

  • Which path does each service use? Is that written down?
  • Do you hold the permit or registration that path requires?
  • Do you have a written contract where one is needed?
  • Can you trace each container from receipt to use or disposal?
  • Could you identify every affected patient within one business day of a recall?

How SiriusRx helps

The SiriusRx Peptide Program teaches the three paths, records which path each practice uses at onboarding, and provides handling, custody, and recall templates. We share information on independent partner pharmacies that meet published standards. The prescriber and the patient choose the pharmacy.

General education, not legal advice.

Sources

  • Va. Code 54.1-3410.2, Compounding; pharmacists' responsibilities: https://law.lis.virginia.gov/vacode/title54.1/chapter34/section54.1-3410.2/.
  • Va. Code 54.1-3420.2, Delivery of prescription drug order: https://law.lis.virginia.gov/vacode/title54.1/chapter34/section54.1-3420.2/.
  • Va. Code 54.1-3455, Schedule VI: https://law.lis.virginia.gov/vacode/title54.1/chapter34/section54.1-3455/.
  • Va. Code 54.1-3434.05, permit to act as an outsourcing facility: https://law.lis.virginia.gov/vacode/title54.1/chapter34/section54.1-3434.05/.
  • Va. Code 54.1-3434.5, nonresident outsourcing facilities to register with the Board: https://law.lis.virginia.gov/vacode/title54.1/chapter34/section54.1-3434.5/.
  • 18VAC110-20-275, delivery of dispensed prescriptions: https://law.lis.virginia.gov/admincode/title18/agency110/chapter20/section275/.
  • FDA, Prescription Requirement Under Section 503A of the FD&C Act, guidance for industry (December 2016): https://www.fda.gov/files/drugs/published/Prescription-Requirement-Under-Section-503A-of-the-Federal-Food--Drug--and-Cosmetic-Act-Guidance-for-Industry.pdf.
  • FDA, bulk drug substances under section 503B of the FD&C Act.
  • FDA, Registered Outsourcing Facilities: https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities.

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.