- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological HealthOffice of Regulatory Affairs
Tamper-resistant packaging requirements for contact lens solutions and tablets are located in 21 CFR 800.12.
See Compliance Policy Guide 7132a.17 (See Sec. 450.500), *Tamper-Resistant Packaging Requirements for Certain Over-The-Counter (OCT) Human Drug Products* for background information and a list of packaging technologies that are capable of meeting the requirements for a tamper-resistant package.
*Material between asterisks is new or revised*
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.