§ 212.80 What are the requirements associated with labeling and packaging PET drug products?

(a) A PET drug product must be suitably labeled and packaged to protect the product from alteration, contamination, and damage during the established conditions of shipping, distribution, handling, and use.

(b) Labels must be legible and applied so as to remain legible and affixed during the established conditions of processing, storage, handling, distribution, and use.

(c) All information stated on each label must also be contained in each batch production record.

(d) Labeling and packaging operations must be controlled to prevent labeling and product mix-ups.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 212.80

Form FDA 483 observations citing this section, fiscal years 2023–2023 (Drugs).

• Labeling and product mix-ups 1

FDA guidance that cites § 212.80

• PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide 5 Aug 2011
• PET Drug Products - Current Good Manufacturing Practice (CGMP) 10 Dec 2009

Amendment history

Federal Register documents that created or amended this section.

• 74 FR 65431 10 Dec 2009