For Drug Distributors

This page applies to the following license types:

• Wholesale Distributors of Dangerous Drugs
• Manufacturers of Dangerous Drugs
• Outsourcing Facilities
• Repackagers of Dangerous Drugs
• Third-Party Logistics Providers

Ohio Laws and Rules

The following is a list of resources to provide licensees with the most up-to-date information on laws and rules governing the legal distribution of dangerous drugs (i.e. prescription drugs):

• Ohio Revised Code
• Ohio Administrative Code
• Recent Rule Changes

Drug Enforcement Administration

The Drug Enforcement Administration, Office of Diversion Control, developed a number of resources on the Federal Controlled Substances Act:

• Controlled Substances Security Manual
• Questions & Answers
• Significant Guidance Documents

Frequently Asked Questions

For more information on a topic, click on one of the questions below or search this FAQ using the search feature at the top of this page.

Licensing

• What changes require the submission of a distributor of dangerous drugs application?
Any change in the ownership, business or trade name, category, or address of a distributor of dangerous drugs requires a new application, required fee, and license. See rule 4729:6-2-05 and this guidance document for additional information.


• How do I discontinue business as a distributor of dangerous drugs?
A drug distributor who plans to discontinue business activities must submit a form to the Board at least thirty days in advance of the proposed date of discontinuing business, unless waived by the Board's executive director or the director's designee due to extraordinary circumstances beyond the licensee's control. The form may be accessed here.


• Does the Board have any guidance regarding on how to answer the legal questions on the initial and renewal applications?
Yes. The Board has developed a guidance document that can be accessed here.



Reporting Theft or Loss of Drugs and Prescription Drug Documents

• When am I required to report a theft or significant loss of dangerous drugs?
A theft or significant loss of dangerous drugs must be immediately reported to the Board. For more information, the Board published a guidance document that is available here.


• When am I required to report the theft or loss of prescription drug documents?
A theft or significant loss of prescription drug documents must be reported to the Board immediately upon discovery. For more information, the Board published a guidance document that is available here.



Responsible Person

• What are the requirements of a responsible person on a terminal distributor license?
The requirements for a responsible person are listed in rule 4729:5-2-01 of the Ohio Administrative Code. Per the rule, the Board has adopted a resolution providing the credential types required for the responsible person of each classification/business type of terminal distributor of dangerous drugs license. The resolution can be accessed here.


• How do I change the responsible person on my drug distributor of dangerous drugs license?
When there is a change of responsible person, the Board must be notified within ten days of the effective date of the appointment of the new responsible person. The Board has developed a guidance document on how to submit notification that can be accessed here.



SUSPICIOUS ORDER MONITORING

• What are the requirements for reporting suspicious orders?
The Board developed a guidance document to assist drug distributors in reporting suspicious orders. The guidance can be accessed here.