Ohio Admin. Code 4729:5-3-04 - Verification of licensure prior to sale or purchase
(A) Before a terminal distributor of
dangerous drugs may purchase dangerous drugs at wholesale, the terminal
distributor shall query the board'
' s online roster (available on the board'
' s website:
www.pharmacy.ohio.gov) to
confirm any of the following:
(1) The seller
is licensed to engage in the sale of dangerous drugs in accordance with section
4729.52 of the Revised Code;
or
(2) The seller is licensed to
engage in the occasional sale or distribution of dangerous drugs at wholesale
in accordance with rule
4729:5-3-09 of the
Administrative Code.
(B)
If no documented query is conducted before a purchase is made, it shall be
presumed that the purchase of dangerous drugs by the terminal distributor is in
violation of section 4729.51 of the Revised Code.
If a licensed terminal distributor of dangerous drugs conducts a documented query at least annually and relies on the results of the query in purchasing dangerous drugs, the terminal distributor shall be deemed not to have violated section 4729.51 of the Revised Code in making the purchase.
(C)
Before a terminal distributor of dangerous drugs may make a sale of dangerous
drugs pursuant to rule
4729:5-3-09 of the
Administrative Code, the terminal distributor shall query the board'
' s online roster
(available on the board'
' s website: www.pharmacy.ohio.gov) to determine
if the purchaser is licensed as either:
(1) A
terminal distributor of dangerous drugs.
For a limited terminal distributor of dangerous drugs license,
a terminal distributor shall also review a current version of the
licensee'
' s
drug list to ensure the purchaser is authorized to possess the drugs
ordered.
(2) A distributor
of dangerous drugs in accordance with division 4729:6 of the Administrative
Code.
(D) Paragraph (C)
of this rule does not apply when a terminal distributor sells or distributes
dangerous drugs at wholesale to any of the following:
(1) A terminal distributor, manufacturer,
outsourcing facility, third-party logistics provider, repackager, or wholesale
distributor that is located in another state, is not engaged in the sale of
dangerous drugs within this state, and is actively licensed to engage in the
sale of dangerous drugs by the state in which the distributor conducts
business; or
(2) Any of the
exempted persons described in section
4729.541 of the Revised
Code.
(3)
The sale, transfer, or distribution of dangerous drugs to an
EMS organization from an institutional pharmacy or facility licensed as a
terminal distributor of dangerous drugs that is owned or operated by a hospital
for purposes of restocking an emergency medical services vehicle if the
institutional pharmacy or facility conducts an annual query to ensure the EMS
organization is properly licensed as a terminal distributor of dangerous
drugs.
(4)
An intracompany transfer made in accordance with rule
4729:5-3-09 of the
Administrative Code, if the entity engaged in the transfer conducts an annual
query to ensure each location is properly licensed as a terminal distributor of
dangerous drugs.
(E) A terminal distributor of dangerous drugs
may make a sale of a dangerous drug to any of the exempted persons described in
section 4729.541 of the Revised Code in
accordance with rule
4729:5-3-09 of the
Administrative Code and shall ensure the purchaser meets the exemption
criteria. To confirm a purchaser meets the exemption criteria, the terminal
drug distributor shall comply with the all
the following:
(1) Provide the purchaser, in a
manner determined by the board, the requirements in Ohio law of when a
purchaser shall hold a license as a terminal distributor of dangerous
drugs;
(2) If the purchaser is a
prescriber, verify the prescriber is appropriately licensed in this state to
prescribe drugs or dangerous drugs or drug therapy related devices in the
course of the individual's professional practice;
(3) Require the purchaser who claims an
exemption to the terminal distributor of dangerous drug licensing requirement
to annually attest in writing, which may include an electronic signature, that
the purchaser meets the licensing exemptions in section
4729.541 of the Revised Code;
and
(4) Ensure that all
attestations are maintained by the terminal distributor for a period of three
years following the date the attestation is signed by the purchaser.
Notes
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.60, 4729.37, 4729.55
Prior Effective Dates: 03/01/2019
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
(A) Before a terminal distributor of dangerous drugs may purchase dangerous drugs at wholesale, the terminal distributor shall query the board's online roster (available on the board's website: www.pharmacy.ohio.gov) to confirm any of the following:
(1) The seller is licensed to engage in the sale of dangerous drugs in accordance with section 4729.52 of the Revised Code; or
(2) The seller is licensed to engage in the occasional sale or distribution of dangerous drugs at wholesale in accordance with rule 4729:5-3-09 of the Administrative Code.
(B) If no documented query is conducted before a purchase is made, it shall be presumed that the purchase of dangerous drugs by the terminal distributor is in violation of section 4729.51 of the Revised Code.
If a licensed terminal distributor of dangerous drugs conducts a documented query at least annually and relies on the results of the query in purchasing dangerous drugs, the terminal distributor shall be deemed not to have violated section 4729.51 of the Revised Code in making the purchase.
(C) Before a terminal distributor of dangerous drugs may make a sale of dangerous drugs pursuant to rule 4729:5-3-09 of the Administrative Code, the terminal distributor shall query the board's online roster (available on the board's website: www.pharmacy.ohio.gov) to determine if the purchaser is licensed as either:
(1) A terminal distributor of dangerous drugs.
For a limited terminal distributor of dangerous drugs license, a terminal distributor shall also review a current version of the licensee's drug list to ensure the purchaser is authorized to possess the drugs ordered.
(2) A distributor of dangerous drugs in accordance with division 4729:6 of the
Administrative Code.
(D) Paragraph (C) of this rule does not apply when a terminal distributor sells or distributes dangerous drugs at wholesale to any of the following:
(1) A terminal distributor, manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor that is located in another state, is not engaged in the sale of dangerous drugs within this state, and is actively licensed to engage in the sale of dangerous drugs by the state in which the distributor conducts business; or
(2) Any of the exempted persons described in section 4729.541 of the Revised Code.
(E) A terminal distributor of dangerous drugs may make a sale of a dangerous drug to any of the exempted persons described in section 4729.541 of the Revised Code in accordance with rule 4729:5-3-09 of the Administrative Code and shall ensure the purchaser meets the exemption criteria. To confirm a purchaser meets the exemption criteria, the terminal drug distributor shall comply with the all the following:
(1) Provide the purchaser, in a manner determined by the board, the requirements in
Ohio law of when a purchaser shall hold a license as a terminal distributor of dangerous drugs;
(2) If the purchaser is a prescriber, verify the prescriber is appropriately licensed in this state to prescribe drugs or dangerous drugs or drug therapy related devices in the course of the individual's professional practice;
(3) Require the purchaser who claims an exemption to the terminal distributor of dangerous drug licensing requirement to annually attest in writing, which may include an electronic signature, that the purchaser meets the licensing exemptions in section 4729.541 of the Revised Code; and
(4) Ensure that all attestations are maintained by the terminal distributor for a period of three years following the date the attestation is signed by the purchaser.
Notes
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.60, 4729.37, 4729.55