DEREGULATION OF PRESCRIPTION DRUGS

To oppose legislation or regulations that permit reclassification of prescription medications to over-the-counter (OTC) status outside of the established Food and Drug Administration (FDA) review and approval process.

Rationale

The FDA requires manufacturers seeking to market a prescription drug product as nonprescription (Rx-to-OTC switch) to demonstrate that the medication is safe and effective for self-care. Regulation requires OTC drug labeling that is easily understood without the guidance of a healthcare professional, and that OTC drugs should treat conditions suitable for self-diagnosis, such as allergies or headache. Approval decisions are predicated on robust evidence from clinical trials, consumer behavioral studies, and post-marketing surveillance data. Manufacturers may also switch a prescription drug to OTC by including an Additional Condition for Nonprescription Use (such as a required questionnaire or pharmacist consultation before purchase) to address safety concerns and ensure patients have the information needed to choose the right medication for their condition.

State-level efforts to deregulate prescription drugs outside of this established framework (e.g., state laws authorizing OTC sale of ivermectin) bypass FDA safety standards and may pose significant risks to patients. While ASHP strongly supports initiatives (such as expansion of pharmacist prescribing authority) that increase patient access to clinically appropriate, evidence-based healthcare services and drug therapies, deregulation of prescription drugs outside the FDA process eliminates essential safeguards. Many prescription medications have important contraindications, toxicities, drug-drug interactions, or monitoring needs that require evaluation by a pharmacist or prescriber or are used to treat conditions requiring a medical diagnosis. Removing the opportunity for patient education and clinical assessment undermines safe medication use, increases the risk of harm, and weakens public trust in the medication-use process.

Drug deregulation also carries significant legal, regulatory, and liability concerns to pharmacists. Although some state laws include provisions for civil or criminal immunity or prohibit license revocation for pharmacists who dispense drugs under such statutes, selling medications without FDA-approved nonprescription labeling may constitute misbranding under the Food, Drug, and Cosmetic Act. This conflict between federal and state law has not yet been adjudicated, creating substantial legal uncertainty. Pharmacies may elect not to offer deregulated drugs under these conditions, further confusing patients and limiting access while failing to achieve the intended goal of expanding medication availability.