Lutetium-177 radioligand manufacturing: which drug GMP rule applies and which licence you need
A therapeutic Lu-177 product is not a PET drug, so parts 210 and 211 apply, alongside the NRC licence and label rules for commercial distribution.
In Short
- Not PET: Parts 210/211 apply.
- NRC 32.72 licence to distribute.
- Shield label: activity at a time.
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
We ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy. Practical orientation, not legal advice; your quality unit decides which rules apply.
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The Radiopharmaceutical Operations Guide
Release timing by framework, supplier to dispatch, late failures and four worksheets.
Lutetium-177 radioligand therapies are made and shipped like other radiopharmaceuticals, but they are not PET drugs. That changes which FDA manufacturing rule applies, while the NRC licence to distribute still matters. Opened: eCFR 21 CFR 210.2 and 212.1, 212.2 and 212.5; 10 CFR 32.72; and 10 CFR 35.40, 35.63 and 35.300, up to date as of 1 Oct 2026. Not opened: any approved product labeling, FDA guidance, EU GMP Annex 3, Agreement State rules, transport rules and NRC guidance documents. Nothing here covers a specific product's process or dose. It is orientation, not legal advice. Sources checked 5 Oct 2026.
Part 212 covers PET drugs only
21 CFR 212.1 defines a PET drug as a radioactive drug that exhibits spontaneous disintegration of unstable nuclei by the emission of positrons and is used for providing dual photon positron emission tomographic diagnostic images. 212.5(a) says a human drug that is not a PET drug must be manufactured under parts 210 and 211.
Which drug CGMP part? (simplified 212.5)
- Positron-emitting, used for PET images.
More on part 212 covers PET drugs only
A lutetium-177 radioligand used for therapy is not a PET diagnostic drug, so the opened text points to parts 210 and 211, with their batch record, laboratory control and quality unit requirements, not to the PET-specific rule.
How 210 and 211 fit with other rules
210.2(a) says the part 210 and 211 regulations supplement, and do not supersede, other regulations unless they conflict; where they conflict, the regulation specifically applicable to the drug prevails. 210.2(b) says a person engaged in only some operations needs to comply only with the regulations for those operations.
More on how 210 and 211 fit with other rules
210.2(c) treats investigational drugs for phase 1 studies differently; read it with your regulatory team if clinical supply is in scope. For a contract producer, write down which operations you perform and which your client keeps.
The NRC Licence to Distribute
10 CFR 32.72(a) sets the conditions for a specific licence to manufacture, prepare or transfer radioactive drugs for commercial distribution to Part 35 medical use licensees. The applicant must be, among other options, registered or licensed with FDA as a drug manufacturer, or a pharmacy or other entity named in 32.72(a)(2).
Worked Example: Shield Label Data for Lot LU-0915
| Item | Entry | Rule |
|---|---|---|
| Symbol and words | CAUTION, RADIOACTIVE MATERIAL | 32.72(a)(4)(i) |
| Drug name | Example radioligand | 32.72(a)(4)(i) |
| Activity at date and time | 7.4 GBq at 12:00 on calibration day | 32.72(a)(4)(i) |
| Container identifier | LU-0915-03 | 32.72(a)(4)(ii) |
- Symbol and words
- Entry
- CAUTION, RADIOACTIVE MATERIAL
- Rule
- 32.72(a)(4)(i)
- Drug name
- Entry
- Example radioligand
- Rule
- 32.72(a)(4)(i)
- Activity at date and time
- Entry
- 7.4 GBq at 12:00 on calibration day
- Rule
- 32.72(a)(4)(i)
- Container identifier
- Entry
- LU-0915-03
- Rule
- 32.72(a)(4)(ii)
More on the NRC Licence to Distribute
The application includes the radionuclide, chemical and physical form, maximum activity per container, and the shielding. Labels on each transport radiation shield and container follow 32.72(a)(4). Agreement States license under their own equivalent rules.
What the shield label carries
Under 32.72(a)(4)(i), each transport radiation shield is labelled with the radiation symbol, the words CAUTION, RADIOACTIVE MATERIAL or DANGER, RADIOACTIVE MATERIAL, the name of the drug or its abbreviation, and the quantity of radioactivity at a specified date and time. 32.72(a)(4)(ii) requires the container label to carry the radiation symbol, the same words and an identifier that ensures the container can be correlated with the information on the shield.
Licence application items, 10 CFR 32.72(a)
More on what the shield label carries
Keep the activity reference date and time in the batch record so label, record and shipment agree.
What the hospital records
At the user site, 10 CFR 35.40 requires a written directive, dated and signed by an authorized user, before administering a therapeutic dosage, naming the drug, dosage and route. 35.63(a) requires the activity of each dosage to be determined and recorded before medical use, and 35.63(b) allows a unit dosage's activity to be found by direct measurement or by decay correction based on the 32.72 licensee's determination.
More on what the hospital records
Your activity figure and its reference time therefore flow directly into the hospital's records. 35.300 sets which sources the user may obtain from.
Questions
Is Lu-177 PSMA made under 21 CFR Part 212?
Part 212 applies only to PET drugs, defined as positron-emitting drugs used for PET diagnostic images. 212.5(a) sends human drugs that are not PET drugs to parts 210 and 211.
What must the shield label show under 10 CFR 32.72?
The radiation symbol, CAUTION or DANGER, RADIOACTIVE MATERIAL, the drug name or abbreviation, and the quantity of radioactivity at a specified date and time, under 32.72(a)(4)(i).
How does the hospital use our activity figure?
Under 10 CFR 35.63(b), a unit dosage's activity may be determined by direct measurement or by decay correction based on the 32.72 licensee's determination, then recorded before use.
Does V5 release Lu-177 batches?
No. V5 records batch steps, results, labels and shipments linked to each lot. Your quality unit decides release, and your licence conditions apply.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
Radiopharmaceutical Manufacturing Readiness: Runs and Dispatch
10 CFR Part 35 Medical Use: Written Directives, Dosage Records and Medical Events- 21 CFR 212 PET Drug cGMP Readiness: Production Evidence Guide
Radiopharmaceutical Release Before All Tests Finish: PET Evidence
Ga-68 Generator Elution Readiness for PET Imaging Sites
USP <825> Radiopharmaceutical Preparation and Compounding: Readiness Guide