Tracking RAM Licensing Limits - Why “Good Enough” Software Isn’t Good Enough for Radiopharmaceutical Therapy Manufacturing

I’m writing this for leaders building or scaling radiopharmaceutical therapy (RPT)

manufacturing programs. If you make, compound, or distribute therapeutic radioisotopes, you already know: staying inside your radioactive material (RAM) license is non‑negotiable. What’s less obvious at project start is how fast license tracking becomes the long pole and how quickly generic ERP or DIY spreadsheets buckle under the real‑world complexity.

Below is the playbook I use on RPT programs to keep possession within limits, keep audits boring, and keep production moving.

Quick note on scope - I reference U.S. NRC and Agreement State rules because they shape how the software must work. Terms and citations are provided for orientation, not legal advice.

What your RAM license actually requires (and why it drives software design)

RAM licenses are more than “you may possess X mCi of Y.” They encode who, what, where, and how, and those specifics must flow into your data model and controls:

• Locations & purposes matter - You must confine possession and use to the locations and purposes authorized by your license (which suite or hot cell, for which activities). (Nuclear Regulatory Commission)

• You must prove the story of every atom - Licensees must keep records showing receipt, transfer, and disposal of byproduct material, with defined retention periods.

• Security & surveillance aren’t optional - Material in storage must be secured from unauthorized removal; material not in storage must be under control and constant surveillance. Your system should help show that control. (Nuclear Regulatory Commission)

• If you approach Category 1/2 thresholds, Part 37 security programs trigger - Aggregation matters (summing ratios to category thresholds). Planning and shipment protections kick in at Category 2 and above. (eCFR)

• Possession limits can change your financial assurance obligations - Quantities and half‑life drive whether you must file or update a Decommissioning Funding Plan and how much assurance you must certify. Your tracking needs to “know” when you cross those bands. (Nuclear Regulatory Commission)

• Manufacturing/distribution license guidance is specific - NRC’s NUREG‑1556 Vol. 12 lays out program‑specific expectations for possession licenses used in manufacturing and distribution—this is the template many reviewers use. (Nuclear Regulatory Commission)

• Agreement States follow compatible rules - States administer materially similar programs; that still means your system must manage state‑by‑state license conditions across sites. (Texas DSHS)

  
  

Implication - The software must think in radionuclides, forms (sealed/unsealed, special form), units (mCi/MBq), locations, authorized uses, and time. A generic item/location/quantity model will miss critical dimensions.

Where generic ERP (and spreadsheets) fail in practice

On multiple RPT implementations, I’ve watched the same failure modes repeat:

1. License data lives in a PDF, not in the system - If limits, locations, forms, and authorized uses aren’t modeled as executable rules, you’re relying on tribal knowledge and post‑hoc reports.

2. No physics in the math - Dose and waste activities change with time. If decay isn’t applied automatically across receiving, WIP, storage, and waste, your “on‑hand” activity is wrong—so are your possession totals.

3. Blind to where you’re possessing - Many platforms can’t track the license’s granularity (site → building → room → hot cell) or enforce location‑specific limits and segregation.

4. No aggregation logic - Part 37 and financial‑assurance calculations require ratio‑sums and banding, not a simple “sum quantity.” If you can’t see when you’re approaching Category 2 or a new assurance tier, you’ll discover it the hard way. (eCFR)

5. Procurement/receiving aren’t gated - Without hard stops, a well‑meaning buyer can receive a generator or sealed source that instantly pushes you over a limit.

6. Waste and returns are invisible - Possession includes what’s in decay‑in‑storage, returned but not transferred, or staged for disposal. If those pools aren’t counted, your compliance math is fiction.

7. Audit evidence is scattered - Inspectors ask for the clean chain: receipt → internal transfers by location → use/production → shipment or disposal, with security controls and surveillance where required. If that story takes three systems and five spreadsheets, you’re already behind. (Nuclear Regulatory Commission)

   
   

What “purpose‑built” RAM license tracking software must do

If you take nothing else from this post, use this checklist when you evaluate platforms or partner IP. You want native capabilities or proven accelerators that do the following:

1) A living “License Registry”

• Model each license (NRC or Agreement State), effective dates, authorized radionuclides, chemical/physical form, possession limits (per location and overall), authorized uses, authorized users/RSO.

• Parse and store license conditions so they can drive system behavior (not just be attached as PDFs). (Nuclear Regulatory Commission)

2) Real‑time possession math

• Compute activity by time for unsealed sources (ingestion at receipt, through WIP, storage, waste), using decay constants and time‑zone aware timestamps.

• Classify stock by state (on hand, in process, in decay‑in‑storage, shipped, transferred, disposed) and include what still counts toward possession.

3) Location‑true inventory

• Track activity at site/building/room/hot cell; enforce segregation so the wrong material never enters an unauthorized area.

• Apply Part 20 security/surveillance expectations as system checks (e.g., exceptions if unsecured in uncontrolled areas; capture acknowledgments when material is staged). (Nuclear Regulatory Commission)

4) Aggregation and thresholds

• Calculate Part 37 aggregation (category ratio sums) continuously; trigger early warnings long before you cross Category 2.

• Track financial‑assurance bands under 10 CFR 30.35 (and the unity rule) and alert if changes are required. (eCFR)

5) Hard gates, not soft warnings

• At purchase order and receipt - Block any line that would breach a limit at the intended location or overall.

• At internal transfer - Prevent moving material into an unauthorized room/hot cell.

• At ship/transfer/disposal - Require destination license verification and record retention per 30.51.

6) Inspector‑ready evidence

• One‑click receipt/transfer/disposal reports with retention metadata that mirrors 30.51;

• Security and shipment artifacts if Category thresholds are met (pre‑planning, NLT arrival times, etc., under Part 37). (Regulations.gov)

7) Multi‑site, multi‑license operations

• Support separate license books per site/jurisdiction with rolled‑up enterprise views;

• Handle license amendments cleanly (effective‑date versioning) so historical math remains correct. (Texas DSHS)

  
  

Our hard‑won lessons implementing this in RPT manufacturing

Across recent RPT programs, a few patterns consistently separate smooth audits from hard days:

• Build from the license “up,” not the BOM “down.” - Start by transcribing license conditions into the registry (radionuclide, form, location, limits, authorized uses/users), then map material masters and locations to those constructs. It’s the only way to make the gates deterministic. (Nuclear Regulatory Commission)

• Treat waste as first‑class inventory - Decay‑in‑storage can be your largest possession bucket on some days. Count it correctly and automate releases from possession when disposal/transfer is complete and documented.

• Design the “three lines of defense.”

  1. Prevention: purchase/receipt/transfer gates;

  2. Detection: near‑real‑time dashboards of possession vs. limits by site/location/nuclide;

  3. Response: automated hold workflows, RSO notifications, and documented variance disposition.

• Make Category 2 a “yellow band.” - Even if you never expect to cross it, trend your aggregation so management isn’t surprised by Part 37 program scope during scale‑up or outages that increase on‑site holdings. (Nuclear Regulatory Commission)

• Plan for amendments and scale - New lines and new rooms mean license amendments. Your configuration needs versioning so historic possession math doesn’t change when the license does. (NUREG‑1556 Vol. 12 is the reviewer’s playbook—assume your reviewers use it.) (Nuclear Regulatory Commission)

  
  

Selection guidance: how to tell if a platform will actually work

When you evaluate software (or partner accelerators), run scenario‑based demos that are hard to fake. Ask vendors to execute these end‑to‑end with your isotopes and limits:

1. Receiving under pressure - Receive a generator plus two sealed sources to a room already near its limit; show the hard stop and the alternative (receiving to an authorized location). Evidence: auto‑generated 30.51‑aligned receipt record.

2. In‑process with decay - Move material into WIP, wait 2 hours, and show activity re‑calculation and possession roll‑forward.

3. Waste surge day - Route a batch to decay‑in‑storage, show possession impact and automatic release after the decay window and documented disposal/transfer.

4. Cross‑license transfer - Attempt an inter‑site transfer across states; system must validate destination license authorization and retain transfer records.

5. Threshold watch - Simulate a production spike that approaches Category 2; show the aggregation math and the Part 37 pre‑planning artifacts for a shipment. (eCFR)

   
   

If a platform can’t do these without custom code or weekly spreadsheets, it will not keep you compliant at scale.

Implementation approach that holds up under inspection

• Kickoff with the RSO - Run a structured workshop to convert license text into system rules; confirm locations, forms, and possession bands.

• Author the test book like an inspector - Write tests around 30.51 record trails, Part 20 secure/surveillance scenarios, and Part 37 thresholds even if you don’t plan to reach them on Day 1.

• Define ownership of the License Registry - Decide who maintains it, how amendments are versioned, and how changes are validated before go‑live.

• Rehearse exception days - Plan outages, waste backlog days, and logistics delays; prove the system’s gates and alerts work when you’re under stress.

Bottom line

For RPT manufacturers, license‑aware software and a license‑first implementation approach are the difference between smooth growth and painful stops. Model your licenses as rules, calculate possession with decay and location truth, gate procurement and internal moves, and keep inspector‑ready evidence by default. The regulations demand it and your scale‑up will thank you.

Glossary

RAM license tracking, RAM possession limits, radioactive material license software, NRC license compliance, Agreement State RAM tracking, Part 37 Category 2 aggregation, 10 CFR 30.51 recordkeeping, 10 CFR 20.1801 security of stored material, 10 CFR 20.1802 control of material not in storage, NUREG‑1556 Vol. 12 manufacturing and distribution, Decommissioning Funding Plan 10 CFR 30.35.