This may come as a surprise, but certain forms of insulin are—and always have been—available over the counter in the United States. When Congress established federal prescription drug regulation in 1951, the types of insulin available at that time, including neutral protamine Hagedorn (NPH) and Regular, now referred to as human insulins, were exempted.1 By contrast, insulin analogs, which were developed much later, such as insulin glargine, insulin detemir, insulin degludec, insulin lispro, insulin aspart, or insulin glulisine, require a prescription. This little-known fact presents both opportunities and potential dangers to patients. It also poses a challenge to clinicians and the US Food and Drug Administration (FDA): is over-the-counter access to insulin an asset or a liability?
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Goldstein JN, McCrary M, Lipska KJ. Is the Over-the-Counter Availability of Human Insulin in the United States Good or Bad? JAMA Intern Med. 2018;178(9):1157–1158. doi:10.1001/jamainternmed.2018.3332
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