Over-the-counter drug

• 21 CFR 201.66 - Format and content requirements for over-the-counter (OTC) drug product labeling.

• Code of Federal Regulations - Title 21: Food and Drugs

• 21 CFR 201.326 - Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.

• Code of Federal Regulations - Title 21: Food and Drugs

• Sen. Joseph R. Biden Jr. Holds a Hearing On Prescription and Over-the-Counter Drug Abuse

• Political Transcript Wire
• August 25, 2009

• Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates

The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of June 17, 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule's compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule's requirements for all affe...

• Federal Register Nbr. 77 FR 27591, May 11, 2012
• Rules and Regulations
• Health and Human Services Department

• 21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

• Code of Federal Regulations - Title 21: Food and Drugs

• TRICARE Over-the-Counter Drug Demonstration Project

This notice is to advise interested parties of a 2-year extension of the demonstration project in which the Department of Defense (DoD) evaluates allowing selected over-the-counter (OTC) drugs to be included on the TRICARE uniform formulary. The Department will continue to evaluate the costs/benefits and beneficiary satisfaction of providing OTC drugs under the pharmacy benefits program when the selected OTC drugs are determined to be clinically effective.

• Federal Register Nbr. 77 FR 66182, November 02, 2012
• Notices
• Defense Department

• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sun Protection Factor Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug Products

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).

• Federal Register Nbr. 77 FR 27230, May 09, 2012
• Notices
• Health and Human Services Department

• Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients

• FR, June 19, 2008
• Proposed rules
• Food and Drug Administration

• Weight Control Drug Products for Over-the-Counter Human Use:

• FR, March 09, 2011
• Proposed rules
• Food and Drug Administration

• 21 CFR 201.322 - Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required alcohol warning.

• Code of Federal Regulations - Title 21: Food and Drugs