10 CFR 35 Readiness for Radiopharmaceutical Medical-Use Sites
Know who signs, what gets measured before each dosage, and what to do in the first day after a medical event.
In Short
- Directives signed before therapy.
- Measure and record every dosage.
- Medical events: call NRC next day.
The Radiopharmaceutical Operations Guide
Release timing by framework, supplier to dispatch, late failures and four worksheets.
- Release timing, framework by framework
- Supplier to dispatch, step by step
- When things go wrong
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The Radiopharmaceutical Operations Guide
Release timing by framework, supplier to dispatch, late failures and four worksheets.
10 CFR Part 35 governs the medical use of byproduct material under an NRC licence; in Agreement States an equivalent state rule applies, which can differ in detail. It names the people who carry responsibility, sets written directive and dosage rules, and defines when a medical event must be reported. This guide is for sites that receive or prepare radiopharmaceutical dosages. It is orientation, not licensing advice. Sources checked 4 Oct 2026.
Who carries responsibility
Under 35.24, licensee management approves in writing licence applications and amendments, each individual before they work as an authorized user, authorized nuclear pharmacist or authorized medical physicist, and permitted programme changes. Management appoints a Radiation Safety Officer who agrees in writing to implement the radiation protection programme, and sets the RSO's authority and duties in writing.
More on who carries responsibility
Associate RSOs can support the RSO, but the RSO cannot delegate the responsibility itself. Keep those appointments, agreements and duty statements as controlled records with a named owner and a review date.
Written Directives
Section 35.40 requires a written directive, dated and signed by an authorized user before administration, for I-131 sodium iodide above 1.11 MBq (30 µCi) and for any therapeutic dosage of unsealed byproduct material. For unsealed therapy other than sodium iodide it states the radioactive drug, dosage and route.
Records Named in Part 35
| Record | Section | Keep |
|---|---|---|
| Written directive | 35.40 / 35.2040 | 3 years |
| Dosage determination | 35.63 / 35.2063 | 3 years |
- Written directive
- Section
- 35.40 / 35.2040
- Keep
- 3 years
- Dosage determination
- Section
- 35.63 / 35.2063
- Keep
- 3 years
More on written Directives
An oral directive is allowed only when delay would jeopardise the patient, and must be written up within 48 hours. Revisions are also dated and signed before administration. Copies are kept for 3 years under 35.2040.
Procedures that give high confidence
Section 35.41 asks for written procedures giving high confidence that the patient's identity is verified before each administration requiring a written directive and that each administration follows the directive. Applicable items include identity checks, checks against the directive, checking manual and computer dose calculations, and determining whether a medical event has occurred.
More on procedures that give high confidence
Write the procedure around how your team actually works: who reads the directive, who checks the label on the syringe, and where each person signs.
Measuring and recording each dosage
Under 35.63 the licensee determines and records the activity of each dosage before medical use. A unit dosage may be measured directly or decay-corrected from the activity determined by a licensed manufacturer or preparer.
More on measuring and recording each dosage
Unless the authorized user directs otherwise, a dosage outside the prescribed range, or more than 20 percent from the prescribed dosage, is not used. The record under 35.2063 names the radiopharmaceutical, patient or ID, prescribed and determined dosage, date and time, and who measured it, and is kept for 3 years.
Medical Events
Section 35.3045 defines medical events by dose thresholds and by errors such as the wrong drug, route, individual or treatment site, with exceptions such as patient intervention. When one is discovered, the licensee notifies the NRC Operations Center by telephone no later than the next calendar day and sends a written report to the NRC Regional Office within 15 days; the referring physician and the individual are also notified as the section sets out.
Worked example: medical event ME-04
- Day 0Wrong-patient administration discoveredNuclear medicine
- Within 24 hReferring physician and individual notifiedLicensee
- Next dayNRC Operations Center calledRSO
- Within 15 daysWritten report to the NRC Regional OfficeRSO
More on medical Events
Read the full section for the thresholds before writing your procedure, and check your Agreement State rule.
Questions
Does Part 35 apply in every state?
NRC applies it directly where it regulates. Agreement States apply their own compatible rules, so check your state programme's text.
How long are dosage records kept?
3 years under 10 CFR 35.2063, and written directives 3 years under 35.2040.
Who signs a written directive?
An authorized user, dated and signed before administration, under 35.40.
Where does V5 fit?
V5 keeps controlled procedures, training records, instrument calibration and dispatch records linked to each lot. Clinical administration and dosage decisions stay with your licensed staff.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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