RAM Licensing & Regulatory

Authorized Nuclear Pharmacist (ANP)

The Authorized Nuclear Pharmacist is the licensed pharmacist named on the RAM license to prepare, compound, and dispense radioactive drug products — including unsealed alpha-emitting therapeutics. Programs that operate an in-house radiopharmacy (rather than receiving unit doses) must name an ANP; many institutional programs name an ANP regardless, to give the radiopharmacy program a defined regulatory anchor.

Responsibilities

Compounding & dispensing

Preparation, compounding, and dispensing of radioactive drug products per USP <825> and the institution's written procedures. For an Ac-225 program, this includes any aseptic manipulation of the supplied vial prior to administration.

Quality assurance

Documented QA on each dose: identity, activity, radiochemical purity (where applicable), sterility safeguards, and chain of custody from receipt through release to the administering team.

Procedure ownership

Owns the radiopharmacy-side SOPs referenced in the RAM application — receipt and wipe test, dose-calibrator constancy/linearity, label generation, and waste segregation at the point of generation.

Coordination with the AU and AMP

Confirms each dispensed dose matches the written directive before release. Partners with the AMP on dose-calibrator setting validation and survey-instrument selection for the radiopharmacy bench.

Certification methods

Board certification

Board certification by a specialty board whose certification process has been recognized by the NRC or an Agreement State (e.g., Board of Pharmacy Specialties — Nuclear Pharmacy). Per 10 CFR §35.55.

Training-and-experience pathway

Documented didactic training plus 700 hours of supervised work experience in the practice of nuclear pharmacy, with preceptor attestation. Submitted with the license application on the appropriate NRC form (or Agreement State equivalent).

Tip

If you receive Ac-225 as patient-ready unit doses, an ANP may not be strictly required on the license — but naming one anyway gives the program a clear owner for receipt, QC, and decay-in-storage records. Regulators tend to notice when no pharmacist owns the bench-level workflow.

References

10 CFR §35.55 — Training for an Authorized Nuclear Pharmacist.
USP General Chapter <825> — Radiopharmaceuticals — Preparation, Compounding, Dispensing, and Repackaging.