Amendments to New York State Public Health Law (PHL) effective September 24, 2002 provide a clinical laboratory holding a New York State clinical laboratory permit the option of offering certain laboratory tests directly to consumers, without written authorization (i.e., an order) from a medical professional, provided the laboratory holds a permit in the appropriate categories. This direct access testing option is available for tests for which a Federal Food and Drug Administration (FDA) approved test kit or collection device is available over-the-counter (OTC) without a prescription, and for tests for the same purpose. Limited Service Laboratories are not eligible to offer direct access testing, and must continue to document authorization of the physician or other health care professional who orders testing ancillary to a medical encounter, or, for public health testing, authorization of the Commissioner or a designee. A list of the tests approved for OTC sale by the FDA's Center for Devices and Radiologic Health (CDRH) is posted at FDA OTC Database.
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Direct Access Testing
Clinical Laboratory Evaluation ProgramWadsworth Center, NYS Department of HealthP.O. Box 509 Empire State PlazaAlbany , NY 12201-0509United StatesP: (518) 485-5378F: (518) 485-5414
Courier Mail AddressClinical Laboratory Evaluation Program, Wadsworth CenterNYS Department of Health, Empire State Plaza, P1 South, Loading Dock JAlbany , NY 12237United States