Indiana medical spas must register and report serious patient events

Medical spas must register with the state before doing business in Indiana. A medical spa provides health care, uses prescription drugs for injection or similar delivery, and presents itself as focused on cosmetic or lifestyle treatments. Physician offices and facilities or practices otherwise licensed by the state are excluded. The board may fine an operator up to $5,000 and require registration. The board must establish a registration process by October 1, 2026. Registration is required beginning January 1, 2027.

Each registered medical spa must name a responsible practitioner with prescribing authority and relevant training. The requirements apply to each medical spa registered under the chapter. The practitioner must be present at the spa long enough to ensure it follows the chapter. The practitioner must ensure workers are licensed, work within their licenses, and have suitable training.

Medical spas must report serious medical events to the board. The duty applies when a patient's serious medical event is associated with a prescription medication or treatment provided by a medical spa. A serious event includes death, a life-threatening event, or hospitalization, as well as an event that puts health in jeopardy and requires medical or surgical intervention. The notice must include available details about the patient, treatment, event, and related medical records. The spa must notify the board no later than 15 days after the event.

People may not compound drugs with bulk drug substances unless specified safety and quality requirements are met. The rules cover compounding drugs for people using bulk drug substances. Compounding or compounded drugs for animal use are excluded. The substance cannot be research grade unless used in a study approved by an institutional review board, or veterinary grade. It must come from an FDA-registered human drug establishment, have a valid certificate of analysis stating its identity, content, and original manufacturing country, and undergo quality testing. Compounding must follow applicable federal and United States Pharmacopeia requirements. The chapter excludes drugs for animal use and certain mixing done according to FDA-approved product directions and consistent manufacturer’s  detailEvidenceIds These drug rules take effect July 1, 2026.