FDA Approves OTC Plan B for Women 18 and Older
Prescription for 'morning after' pill still required for younger females
THURSDAY, Aug. 24, 2006 (HealthDay News) -- The emergency contraceptive Plan B, often referred to as the "morning after" pill, was approved by the U.S. Food and Drug Administration on Thursday for over-the-counter sale to women aged 18 and older.
Younger women and girls will still need a prescription for the drug, which contains higher doses of an ingredient found in prescription birth control pills. Designed to prevent pregnancy if taken within 72 hours of unprotected sex, it's been available with a prescription in the United States since 1999.
Barr Pharmaceuticals' Duramed subsidiary will make over-the-counter Plan B available "with a rigorous labeling, packaging, education, distribution, and monitoring program," the FDA said in a statement. Distribution will only be available through licensed drug wholesalers, pharmacies, and clinics to prevent unauthorized non-prescription sales to those under age 18, the statement added.
Barr originally applied to the FDA for over-the-counter sales of Plan B to females of any age, but the agency rejected that plan, saying it didn't have enough evidence that the drug could be used effectively and safely by females under age 18 without a medical professional's supervision.
To learn more about Plan B, check this FDA Questions and Answers page.