Medical Devices Draft Guidance on Over the Counter (OTC) Screening Tests for Drugs of Abuse: Guidance for Premarket Notifications; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Over the Counter (OTC) Screening Tests for Drugs of Abuse: Guidance for Premarket Notifications." FDA is issuing this draft guidance to provide information about studies and labeling considerations applicable to OTC screening tests that use urine as the clinical specimen for any combination of one or more of these drugs: Amphetamine (and, or methamphetamine), cocaine, cannabinoids, opiates, and phencyclidine. This draft guidance defines OTC use for the purposes of this document as use in home, workplace, insurance, and sports settings, and includes requests for comments on confirmatory testing and OTC alcohol testing. This draft guidance is neither final nor in effect at this time.