Access to Plan B Emergency Contraception in an OTC Environment

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On August 24, 2006, the Food and Drug Administration (FDA) approved Plan B, the dedicated emergency contraception (EC) product, for over-the-counter (OTC) sale to individuals ages 18 and older. Women 17 and younger are still required to obtain a prescription to get Plan B. Plan B remains available by prescription for women of all ages from authorized prescribers, such as doctors, nurses, physicians' assistants, and midwives. Plan B is also available to women of all ages via the pharmacy access model, which allows a specially trained pharmacist to provide Plan B directly to women without requiring an advance prescription from a doctor or clinic. The FDA decision to establish a dual-label status for Plan B virtually creates a new, third class of drugs and sets a new precedent with significant impact on the medical and legal professions. This article seeks to illuminate for health care providers and legal experts the implications of providing EC in the new OTC environment.
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