Establishing the medical spa oversight Act, and making penalties applicable

The bill lists several examples of services. The bill also defines “adverse event”, “biological product”, “bulk drug substance”, “prescription device” (device), “prescription drug” (drug), and “serious adverse event”. The bill prohibits a business from handling, storing, administering, dispensing, or distributing drugs unless the business is licensed by the board of medicine (board) as a spa. The bill also prohibits a business from providing services unless licensed by the board. The bill requires the board to maintain a public database on the board’s internet site of each spa and details the minimum information the database must include. Under the bill, a spa is a dispenser as defined in section 581 of the federal Drug Supply Chain Security Act and is required to comply with all requirements of a dispenser in that Act. The bill requires a spa to store drugs and devices in areas that are dry, well-lit, well-ventilated, and maintained in a clean and orderly condition. Drugs and devices requiring specific storage conditions, such as cold chain storage, must be stored according to instructions provided by the manufacturer of the drug or device. Drugs and devices must be maintained under appropriate supervision with controlled distribution. The bill requires a spa and the spa’s responsible person to ensure the spa has sufficient security controls and procedures to deter and detect the theft and diversion of drugs. _____ prior board approval. The responsible person must ensure each spa location for which the responsible person is designated complies with the bill. Under the bill, a person’s submission of an application for a spa license constitutes permission for the board or the board’s authorized agent to enter and inspect the person’s proposed spa facilities and audit the person’s proposed services. The bill requires an inspection and audit to occur prior to a person’s initial spa licensure and allows the board to conduct inspections and audits after the person’s initial licensure. The bill requires a spa to provide written notice to the board within five business days from the date a serious adverse event occurs at the spa. The bill details the information the notice must include.16 (consumer fraud) when a spa represents that a drug is of a particular standard, quality, or grade if the drug is not of that standard, quality, or grade; represents that a drug or a service has sponsorship, approval, characteristics, ingredients, uses, benefits, or quantities that it does not have; or represents that a drug or service is approved by the United States food and drug administration (FDA) when the FDA has not approved the drug or service. The bill allows the board to maintain an action in the name of the state for an injunction to restrain or prevent a violation of the bill or rules adopted pursuant to the bill. Upon the board’s request, the bill requires the attorney general to commence proceedings to enforce the bill and, at the request of the attorney general, a county attorney with jurisdiction must appear and prosecute the action. The bill allows the board to impose an administrative penalty of up to $500 per violation on a person as detailed in the bill. The assessment and payment of an administrative penalty shall not be considered a disciplinary action and shall be confidential. _____ the board into the general fund of the state. The bill requires the board to maintain a public record of disciplinary actions involving violations of the bill. The bill requires the board to adopt rules to implement and administer the bill.16.