FDA Approves Plan B For Limited OTC Use
The FDA announced today that it has approved the use of the oral contraceptive Plan B for limited use by women 18 years and older. According to an FDA press release, Barr has agreed to implement the CARE (Convenient Access, Responsible Education) that will:
- Provide consumers and healthcare professionals with labeling and education about the appropriate use of prescription and OTC Plan B, including an informational toll-free number for questions about Plan B;
- Ensure that distribution of Plan B will only be through licensed drug wholesalers, retail operations with pharmacy services, and clinics with licensed healthcare practitioners, and not through convenience stores or other retail outlets where it could be made available to younger women without a prescription;
- Packaging designed to hold both OTC and prescription Plan B. Plan B will be stocked by pharmacies behind the counter because it cannot be dispensed without a prescription or proof of age; and
- Monitor the effectiveness of the age restriction and the safe distribution of OTC Plan B to consumers 18 and above and prescription Plan B to women under 18.
Learn More
- Click here to read a Wall Street Journal story about the FDA annoucement.
- Click here to access the FDA Web site focusing on Plan B.
- Click here to read an article recently posted on this blog about the Plan B issue.
