On January 4, 2017, Governor Kasich signed legislation effectively expanding the list of those required to possess Terminal Distributor of Dangerous Drugs (TDDD) licenses and the obligations of manufacturers and distributors to verify licensure before selling or distributing dangerous drugs. The most significant change is the broadened applicability to licensed healthcare professionals (HCPs). Previously, a TDDD license was not required for a licensed HCP practicing as a sole proprietor. A TDDD license was also not required for a corporate practice that had a sole shareholder or member that was a licensed HCP. Now, HCPs or HCP practices that purchase or possess controlled substances are required to have TDDD licenses regardless of how their practices are structured. Consequently, manufacturers and their 3PLs have expanded validation requirements, particularly those that sample controlled substances to HCPs. These changes also pertain to the distribution of samples and impose rather onerous requirements on manufacturers. In order to comply with the law and continue to distribute sample product into Ohio, companies should update their validation procedures to capture the necessary information. Companies distributing legend drug samples should also consider the pros and cons of the abbreviated procedures and determine whether it is worthwhile or feasible to update sample request/receipt forms to comply with the law.
As you read through the requirements, you will note that they specifically refer to selling and purchasing. Notwithstanding, the requirements do pertain to samples as Ohio defines "Sale" and "sell" broadly to include the "delivery, transfer, barter, exchange, or gift, or offer therefor, and each such transaction made by any person, whether as principal proprietor, agent, or employee." OH Rev. Code §4729.01(J).
When is a prescriber required to hold a TDDD license?
General rule: No person shall possess dangerous drugs unless s/he is a licensed TDDD or is otherwise exempt from that restriction.
- Licensed HCP;
- Prescriber practice that is a corporation (including S corporation), LLC, or professional association if the business has a sole shareholder who is a licensed HCP authorized to prescribe drugs;
- Corporations, LLCs, partnerships, professional associations if to be a shareholder, member, or partner each person must be licensed or certified and each shareholder, member, or partner is a HCP licensed and authorized to prescribe drugs. Currently, dental practices are the only groups that fall under this exemption.
The exemptions do not apply, however, and a TDDD license is required with respect to:
- The possession, custody and control of, and distribution of; or
- Dangerous drugs that are compounded or used for the purpose of compounding; or
- Controlled substances.
- Pain management clinics, or prescribers employed by a pain management clinic; or
- Facilities, clinics, other locations with an office-based opioid treatment classification or prescribers employed by such business entities.
License Validation Process
Before a registered wholesale distributor of dangerous drugs may sell dangerous drugs at wholesale to any person, it must validate that the purchaser has a TDDD license by either:
- obtaining a copy of the current TDDD certificate; or
Before a licensed terminal distributor of dangerous drugs may purchase dangerous drugs at wholesale, from either a wholesale distributor, or another terminal distributor making an "occasional" wholesale distribution as authorized by rule 4729-9-10 of the Ohio Administrative Code, the terminal distributor shall obtain from the seller or the board’s online registry either:
- the wholesale distributor’s registration number; or
- the terminal distributor’s license number for occasional wholesale sales.
Before a wholesale distributor of dangerous drugs may make a sale (this includes provision of samples) of a dangerous drug to a prescriber the wholesale distributor must:
1. Validate the prescriber as a licensed TDDD by doing the following; or
- Obtain a copy of the prescriber’s current TDDD license certificate; or
- Use the board's online registry - https://license.ohio.gov/lookup/default.asp?division=96 - and, if the license is limited, obtain a copy of the addendum listing the drugs the licensee is authorized to purchase and possess.
2. The requirements imposed upon manufacturers and wholesalers in regard to exempt HCPs are even more burdensome. If a HCP claims an exemption from the TDDD licensure requirement, the manufacturer or wholesaler must confirm that the prescriber is exempt from the TDDD licensure requirement by obtaining the following documents, as applicable; for
- Individual prescribers doing business as a sole proprietor or sole shareholder of a corporation or LLC and a dentist:
- Copy of his/her current license to practice and the license must authorize the use of the drugs requested; and
- If doing business as a sole shareholder of a corporation or single member LLC, official documentation stating s/he is sole shareholder or member.
- All exempt prescribers must also provide:
- Address of all sites of practice where the drugs will be delivered to and stored for use; and
- Verification from licensing board that license is in good standing and that there are no restrictions on the license. If the license is restricted, a copy of the official documents restricting the license.
3. For the sale of non-controlled drug samples and complimentary supplies that are shipped to a prescriber, the verification procedure is relaxed for those claiming an exemption to the TDDD requirements:
- Verify that the prescriber’s license is in good standing at - https://elicense.ohio.gov/OH_HomePage.
- Wholesale distributor, manufacturer, 3PL or any similar entity must update the company’s request form to:
- State, in a conspicuous manner, when a prescriber must hold a TDDD and instructions on where to access guidance from the Board; and
- Require the prescriber claiming an exemption to the TDDD requirement to attest that s/he meets one of the exemptions.
As a result of these changes to the law, manufacturers and their 3PLs must coordinate with each other to ensure that they are validating the TDDD licensure of HCPs and others, as required. This entails the implementation of processes for identifying those that must be validated, how they will be validated, and by whom. This will likely also require that existing ordering or request processes be modified, including that necessary revisions be made to the sample request form to comply with the notification requirements. The processes may even be different depending upon the product. For example, as described above, the State of Ohio Board of Pharmacy issued a modified verification process for the sale of non-controlled drug samples and complimentary supplies that are shipped to a HCP. It will be even more challenging for companies to obtain the necessary corporate documents from HCPs claiming exemptions and exempt HCPs may find it easier to obtain the TDDD license. To the extent that compliance with the law’s requirements is impracticable, some companies may want to evaluate the necessity of providing their products to HCPs at all.