A Terminal Distributor of Dangerous Drugs (TDDD) is a person (includes an individual; partnership; association; limited liability company; corporation; the state; any political subdivision of the state; and any district, department, or agency of the state or its political subdivisions) 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.
On May 1, 2016, the State of Ohio Board of Pharmacy’s (SOBP) new rules on drug compounding by prescribers went into effect that required all locations to hold a TDDD license in order to possess, have custody or control of, or distribute dangerous drugs that are compounded or used for the purpose of compounding. This requirement included those who are engaged in a form of compounding commonly referred to as reconstitution (which can include vaccines).
Because many prescribers were unaware of the need to obtain a TDDD license, the SOBP granted an extension until Thursday, September 1, 2016, for prescribers to obtain a TDDD license for all locations that perform drug compounding (including reconstitution) or order compounded drugs to their offices.
The Ohio Academy of Family Physicians joined forces with the Ohio State Medical Association and other physicians’ organizations to address concerns with the SOBP relative to the adoption and implementation of this burdensome and costly rule.
The SOBP released a statement on May 11, 2016, advising previously exempt prescriber practices to refrain from application to the SOBP as a TDDD until after the SOBP’s June 2016 meeting.
OAFP President Tom Houston, MD, authored a May 17 letter about the Academy’s concerns for consideration at the June SOBP meeting.
During the SOBP’s June meeting, it was decided that it was in the best interest of all involved to take a month to assess options as it relates to the non-hazardous prescriber compounding rule (4729-16-04) and as such, the previously issued guidance remains in effect.
- Applications for Licensure
- FAQ on Application Legal Questions
- Prescriber Compounding Rules for Hazardous Drugs
- Compounding in Ohio (includes the legal definition of compounding).
- Guidance Document – Changes in Ohio Law Impacting Buprenorphine Used for the Purpose of Treating Drug Dependence or Addiction
- OAFP Files Additional Comments on Compounding Rules (Weekly Family Medicine Update, August 2, 2016)
- Pharmacy Board Revises Proposed Compounding Rules (Weekly Family Medicine Update, July 26, 2016)
- OAFP Calls for Pharmacy Board to Indefinitely Suspend Compounding Rules (Weekly Family Medicine Update, July 12, 2016)
- Pharmacy Board Met June 6 to Consider Concerns Expressed About Compounding Rules (Weekly Family Medicine Update, June 6, 2016)
- Pharmacy Board to Revisit TDDD Licensure Rule (Weekly Family Medicine Update, May 17, 2016)
- Update on TDDD Licensing Requirement (Weekly Family Medicine Update, May 10, 2016)
- Pharmacy Board Adopts New TDDD License Requirements for Possessing Compounded Drugs (Weekly Family Medicine Update, May 3, 2016)
- Board of Pharmacy Adopts New Rules on Drug Compounding by Prescribers (Weekly Family Medicine Update, March 8, 2016)