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*
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.