CFR section
21 CFR 211.132(b): Tamper-evident packaging requirements for over-the-counter (OTC) human drug products
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart G-Packaging and Labeling Control
Key facts
| Citation | 21 CFR 211.132(b) |
|---|---|
| Section | Tamper-evident packaging requirements for over-the-counter (OTC) human drug products |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart G-Packaging and Labeling Control |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Drugs, General |
| Regulation text (excerpt) | (b) Requirements for tamper-evident package. (1) Each manufacturer and packer who packages an OTC drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale shall package the product in a tamper-evident package, if this product is accessible to the public while held for sale. A tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that… |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.