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New Ohio Rules for Reporting Theft or Significant Loss of Dangerous Drugs in the state of Ohio

February 6, 2019

Background

Effective March 1, 2019, rules 4729:5-3-02 and 4729:6-3-02 of the Ohio Administrative Code will require all terminal distributors and drug distributors (manufacturers, wholesalers, third-party logistics providers, repackagers and outsourcing facilities) to report theft or significant loss of dangerous drugs (controlled and non-controlled prescription drugs) via the Board’s online portal.

A Terminal Distributor of Dangerous Drugs (TDDD) is a person (individual, partnership, association, limited liability company, corporation or government agency) 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.

Sites licensed as TDDDs include, but are not limited to, pharmacies, hospitals, nursing homes, emergency medical service organizations, laboratories and all other locations that procure dangerous drugs for sale or other distribution by or under the supervision of a pharmacist or licensed health professional authorized to prescribe drugs.

A Dangerous drug, as defined by the Ohio Board of Pharmacy section 4729.01 means any drug or drug product whose commercial package bears a label containing the symbol "Rx only", the legend “Caution: Federal Law Prohibits Dispensing Without Prescription" or "Caution: Federal Law Restricts This Drug To Use By Or On The Order Of A Licensed Veterinarian," or any similar restrictive statement.

What is the new requirement for Ohio Veterinarians and Henry Schein Ohio Distribution Center?

Effective 3/1/19 the Ohio Board of Pharmacy is requiring veterinarians to notify and report any theft or significant loss notification via telephone upon discovery of a theft or significant loss of any dangerous drugs (controlled and non-controlled drugs) in addition to reporting requirement set by the DEA regulations in §1304.74(c) if the theft or significant loss was a controlled substance.  

How does this impact HSAH Ohio Customers and HSAH Columbus Distribution?

Effective 3/1/19, HSAH and HSAH customers will be required to notify the Ohio BOP of any theft or significant loss immediately upon discovery by submitting through the Board’s online portal or by calling the Board’s main line (614-466-4143) and speak to the Compliance and Enforcement Department.  

The Ohio BOP defines “upon discovery” to mean the following:

  • Upon the reasonable suspicion that a loss has occurred, whether the loss can be proven to be an actual theft or significant loss, or not, a report shall be made to the Board of Pharmacy.
  • In addition to the initial notification requirements, a licensee is required to submit a detailed report of the theft or significant loss to the Board using the online portal within 30 days following the discovery of such theft or significant loss. The detailed report is similar to a DEA 106 Form.
  • The theft and significant loss of drug documents also require notification to the Board. Drug documents include any of the following: Uncompleted prescription blank(s) used for writing a prescription; Written prescription order(s) not yet dispensed; Original prescription order(s) that have been dispensed; or DEA controlled substance order forms (DEA Form 222).
  • The link for reporting is included for your convenience: https://www.pharmacy.ohio.gov/Licensing/olrlookup.aspx

 

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