Title Medication – Over The Counter (OTC) Products
Statute or Rule 58A-5.0185(8) FAC

(8) OVER THE COUNTER (OTC) PRODUCTS. For purposes of this subsection, the term over the counter includes, but is not limited to, over the counter medications, vitamins, nutritional supplements, and nutraceuticals, hereafter referred to as OTC products, that can be sold without a prescription.

(a) A facility may keep a stock supply of OTC products for multiple resident uses. When providing any OTC product that is kept by the facility as a stock supply to a resident, the staff member providing the medication must record the name and amount of the OTC product provided in the resident’s medication observation record. All OTC products kept as a stock supply must be stored in a locked container or secure room in a central location within the facility and must be labeled with the medication’s name, the date of purchase, and with a notice that the medication is part of the facility’s stock supply.

(b) OTC products, including those prescribed by a health care provider but excluding those kept as a stock supply by the facility, must be labeled with the resident’s name and the manufacturer’s label with directions for use, or the health care provider’s directions for use. No other labeling requirements are required.

(c) Residents or their representatives may purchase OTC products from an establishment of their choice.

(d) A health care provider’s order is required when a nurse provides assistance with self-administration or administration of OTC products. When an order for an OTC product exists, the order must meet the requirements of paragraphs (b) and (c) of this subsection. A health care provider’s order for OTC products is not required when a resident self-administers his or her medications, or when unlicensed staff provides assistance with self-administration of medications.

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