The U.S. Food and Drug Administration is set to review a drugmaker’s application for the first over-the-counter birth control pill in November 2022, with a decision expected in the first half of 2023.
An approved over-the-counter hormonal birth control product would not require a prescription and would be considered self-care, defined as “the practice of individuals looking after their own health using the knowledge and information available to them.”
Currently, in many U.S. states, pharmacists can already prescribe hormonal contraception that requires a prescription. The process begins with a pharmacist consultation to screen patients for eligibility, collect a medical history and measure blood pressure. If the patient qualifies, the pharmacist can provide a prescription to the patient; if not, the pharmacist refers the patient to a physician.
The FDA’s approval of an over-the-counter birth control pill will further expand options for people seeking hormonal contraception to all 50 states. The first such over-the-counter pill – a non-estrogen, progestin-only contraceptive – could become available by mid-2023.
We are a pharmacist and a public health expert. We see the move toward over-the-counter birth control as an important step toward accessible and equitable reproductive health care for all Americans, and pharmacists will play an indispensable role in that effort.