The Indiana Legend Drug Act, IC 16-42-19, allows specific Indiana practitioners to dispense legend drugs directly to their patients in the course of their professional practice.
Who Can Dispense
The legend drug must be delivered in good faith by a practitioner listed below in the course of their professional practice:
- A physician licensed under IC 25-22.5.
- A veterinarian licensed to practice veterinary medicine in Indiana.
- A dentist licensed to practice dentistry in Indiana.
- A podiatrist licensed to practice podiatric medicine in Indiana.
- An optometrist who is licensed to practice optometry in Indiana and certified under IC 25-24-3.
- An advanced practice nurse who meets the requirements of IC 25-23-1-19.5.
- A physician assistant licensed under IC 25-27.5 who is delegated prescriptive authority under IC 25-27.5-5-6.
What Can Be Dispensed
As long as the labeling requirements and reporting requirements (if dispensing controls) are met, an Indiana practitioner may dispense any legend drug they are allowed to prescribe under their:
- Indiana professional license;
- CSR and DEA registrations (if dispensing controlled substances); and/or
- Collaborative practice agreement (if this is required to prescribe)
The immediate container in which the legend drug is delivered must bear a label that includes the following information:
- The directions for use of the drug.
- The name and address of the practitioner.
- The name of the patient.
- If the drug is prescribed for an animal, a statement of the species of the animal.
This does not prohibit a practitioner from delivering professional samples of legend drugs in their original containers in the course of the practitioner's practice when oral directions for use are given at the time of delivery.
Reporting Requirements for Dispensing Controlled Substances
A practitioner may dispense controlled substances; however, if the amount is more than a 72-hour supply, the practitioner is required to report the prescription to Indiana's Prescription Monitoring Program, INSPECT. The dispensed controlled substance, if more than a 72-hour supply, must be reported to INSPECT not more than seven (7) days after the date on which it was dispensed.
The following must be collected and reported to INSPECT:
- The controlled substance recipient's name and address.
- The controlled substance recipient's or the recipient representative's identification number or the identification number or phrase designated by the INSPECT program.
- The controlled substance recipient's date of birth.
- The national drug code number of the controlled substance dispensed.
- The date the controlled substance is dispensed.
- The quantity of the controlled substance dispensed.
- The number of days of supply dispensed.
- The dispenser's United States Drug Enforcement Agency registration number.
- The prescriber's United States Drug Enforcement Agency registration number.
- An indication as to whether the prescription was transmitted to the pharmacist orally or in writing.
- The controlled substance recipient's method of payment for the controlled substance dispensed.
For questions on how to upload the information to INSPECT or how to register to upload, please visit their website at www.in.gov/pla/inspect or e-mail inspect@pla.IN.gov.