The Part 212 rewrite missed its target date again

Introduction

Title 21 of the Code of Federal Regulations (CFR), Part 212 is the manufacturing rule of the Food and Drug Administration (FDA) for positron emission tomography (PET) drugs, Current Good Manufacturing Practice for Positron Emission Tomography Drugs^[1]. FDA published the final rule in the Federal Register, the US government's daily journal of rules and notices, on 10 December 2009, effective 12 December 2011^[2][3].

FDA plans to change it. Its current entry in the Unified Agenda, the twice-yearly list of planned federal rules, carries the same title under Regulation Identifier Number 0910-AH58^[4][5][6]. It sits at the Proposed Rule Stage, with one action: a Notice of Proposed Rulemaking, dated 09/2026^[4]. The abstract gives two aims: drop its citation of an out-of-date United States Pharmacopeia (USP) chapter, and streamline Part 212 so it applies to every PET drug, investigational and research ones included^[4].

What happened

As of 25 October 2026, a Federal Register search for "positron emission tomography" since 01 May 2026 returns no FDA proposed rule^[7]. It has slipped before: Spring 2025 said 05/2026^[8], and Fall 2017, the first edition to carry it, said 11/2018^[9]. It has been missing its date for nearly eight years, so I won't guess when it lands.

I read the two aims as one change. 21 CFR 212.5(b) lets a PET drug made under an investigational new drug application (IND), or with Radioactive Drug Research Committee (RDRC) approval, meet the manufacturing requirements one of two ways: comply with Part 212, or follow USP General Chapter <823>, Radiopharmaceuticals for Positron Emission Tomography—Compounding, in USP 32 / National Formulary 27, dated 01 May 2009^[10]. <823> is the only USP chapter Part 212 cites, so that 2009 chapter is the outdated reference^[1]. Take it out and the second route goes with it. Products on the chapter route would then answer to the revised Part 212 alone, their standard operating procedures (SOPs) and batch records read against it.

The rule hasn't changed. Inspections aren't waiting for it. Today's Part 212 is the rule in force and the text an investigator inspects against. A proposed rule is a plan put out for comment. The rulemaking guide from the Office of the Federal Register, which publishes federal rules, says the agency can still change it, re-propose it or drop it, and that it is the final rule that carries an effective date and is written into the CFR^[11]. Inspecting against a draft would hold labs to text that may never become law.

The friction is in how the rule gets applied. AuntMinnie, a news site for medical imaging professionals, reported on 04 June 2026 on the Radiopharmaceutical Manufacturers and Theranostics Alliance (RMTA), a division of the National Electrical Manufacturers Association^[12][13][14]. The alliance finds FDA inspection expectations inconsistent, naming precursor identity testing and annual stability testing as problem areas^[14]. Its regulatory committee chair said: "Policies are being implemented inspection by inspection rather than through guidance or rulemaking."^[14]

Takeaway

Three checks while the rule waits, in the order I'd run them:

1. Which route each investigational PET product uses. If an SOP says "per USP <823>", find out which edition it means. Then check that the batch records show compliance, not just the SOP.
2. How your SOPs cite standards. Cite the regulation section and write the requirement into the SOP. A chapter version baked into an SOP turns every outside revision into a change control.
3. How you trust a precursor. If you accept a precursor lot on the supplier Certificate of Analysis (CoA), write down the finished-product test that justifies it under 21 CFR 212.40(c)^[15]. Then record how you check that CoA over time, such as a periodic in-house identity test. Precursor identity is one of the problem areas RMTA named^[14].

The first check is the cheapest. Skipped, it can become an inspection finding on a product you thought was covered.

Search your PET SOPs for "<823>" this week and write down what you find.