The Ohio Board of Pharmacy (BoP) notified manufacturers and distributors July 14, 2017, of a resolution creating a modified process for verifying the Terminal Distributor of Dangerous Drugs (TDDD) License of a recipient of a non-controlled dangerous drug sample or complimentary supply. The BoP Resolution: Non-Controlled Dangerous Drug Licensure Verification Prior to the Sale of Sample Drugs or Complimentary Supplies adopted July 12, 2017, updates and clarifies expectations for license verification under O.R.C. 4729-9-12, including a change that could require industry to create new sample and complimentary supply request forms.
What products are included in the modified process?
The resolution applies only to samples or complimentary supplies of “dangerous drugs” that are not also controlled substances. Under O.R.C. 4729.01, dangerous drugs generally include legend drugs, drugs intended for injection and biologics.
The resolution is forward-looking, using definitions for “sample” and “complimentary supply” that are in the process of being incorporated into O.R.C. 4729-9-13. Here, samples include dangerous drugs marked as samples. Complimentary supplies include dangerous drug starter packs, initial dose packs, replacement product and similar products distributed without charge that are not marked as samples.
What is a TDDD License?
A TDDD is any “person who is engaged in the sale of dangerous drugs at retail, or any person, other than a wholesale distributor or a pharmacist, who has possession, custody, or control of dangerous drugs for any purpose other than for that person's own use and consumption, and includes pharmacies, hospitals, nursing homes, and laboratories and all other persons who procure dangerous drugs for sale or other distribution by or under the supervision of a pharmacist or licensed health professional authorized to prescribe drugs” (O.R.C. 4729.01).
The BoP requires all TDDDs to obtain a license, with limited exceptions described in O.R.C 4729.541. Manufacturers and distributors are expected to verify the TDDD license before the distribution of free samples and complimentary supplies.
Will sample and complimentary supply request forms have to change?
Under the modified process, in addition to 1) verifying the requesting prescriber’s license to practice as required by the federal Prescription Drug Marketing Act and the BoP and 2) verifying the TDDD license number if provided, the manufacturer or distributor must update the company’s sample/complimentary supply request forms to state the TDDD license requirements and obtain an attestation of a prescriber’s exemption from TDDD license requirements if claimed.