Patient Access to Compounded Medical Items

The bill provides that, if the action is undertaken in accordance with applicable federal and state law:

• A licensed person may compound a drug or device in the state;
• A state-licensed pharmacy or a distribution facility registered with the federal food and drug administration (licensed 503B outsourcing facility) may supply a compounded drug or device to a licensed health-care provider, pharmacy, facility, or organization; and
• A licensed health-care provider, pharmacy, facility, or organization may obtain, dispense, or administer a compounded drug or device supplied by a state-licensed pharmacy or a licensed 503B outsourcing facility.

In addition, the bill prohibits the state board of pharmacy from adopting rules that are more restrictive than federal or state law regarding the compounding of drugs or devices.

Current law exempts drugs that are intended solely for investigational use by experts qualified by scientific training and experience and that are plainly labeled for investigational use only from the sales and delivery prohibition for new drugs. The bill also exempts from the prohibition:

• Drugs that are reviewed by an institutional review board and plainly labeled for investigational use only; and
• Compounded drugs and devices if the compounding of the drug or device is undertaken in accordance with applicable federal and state law.(Note: This summary applies to this bill as introduced.)