The Durham-Humphrey Amendments also amended the FDC Act (§ 503(b)(3)) to state that FDA “may by regulation remove drugs subject to [FDC Act § 505 [(i.e., new drugs)] from the requirements of [FDC Act § 503(b)(1)] when such requirements are not necessary for the protection of the public health.” FDA’s regulation implementing § 503(b)(3) is codified at 21 C.F.R. § 310.200(b), and states that FDA may approve an Rx-to-OTC switch when Rx dispensing is: not necessary for the protection of the public health by reason of the drug’s toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, and . . . [t]he drug is safe and effective for use in self-medication as directed in proposed labeling. There are two different mechanisms under the FDC Act for FDA to make an Rx-to-OTC switch: (1) FDC Act § 503(b)(3) explicitly provides FDA with the authority to issue a regulation changing the status of an Rx drug to an OTC drug; and (2) the FDC Act grants FDA the authority to approve and reject NDAs. FDA’s regulation at 21 C.F.R. § 310.200(b), which implements FDC Act § 503(b)(3), identifies processes for initiating consideration of an Rx-to-OTC switch.

f this potential approval are significant, especially at a time when women’s reproductive rights are under attack in many states. Since the Dobbs decision announced last summer, access to abortion care has been severely limited or prohibited in several states. Making birth control pills more accessible through OTC by eliminating the need for a prescription could help reduce unintended pregnancies.However, some challenges and limitations remain. The next step in the switch of Opill from prescription (Rx) to OTC use involves a vote by the FDA, ruling on the recommendation. FDA will approve an Rx-to-OTC switch application when FDA determines that the previous prescription status is “not necessary for the protection of the public health by reason of the drug’s toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, and . . . the drug is safe and effective for use in self-medication as directed in proposed labeling.” See 21 C.F.R. § 310.200(b). This vote is expected during the 2023 summer months.[View source.]