Ohio Admin. Code 4729:6-3-04 - Verification of licensure prior to sale or purchase
(A) As used in section
4729.60 of the Revised Code and
in this rule, "roster" means any of the following:
(1) The online roster maintained as part of
the board's elicensing
electronic licensing system (available on the board's
website: www.pharmacy.ohio.gov);
(2) An electronic list of licensees and
registrants if maintained by the board; and
(3) Any other format capable of meeting the
requirements of section
4729.60 of the Revised Code and
this rule that has been approved by the board.
(B) Before a drug distributor may sell or
distribute dangerous drugs to any person in this state, except as provided in
paragraph (C) of this rule, the distributor shall conduct a documented query of
a roster maintained by the board 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 drug 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.
(C)
Paragraph (B) of this rule does not apply when a drug distributor sells or
distributes dangerous drugs to any of the following:
(1) A person specified in division (B)(4) of
section 4729.51 of the Revised Code;
or
(2) Any of the exempted persons
listed in section 4729.541 of the Revised
Code
(D) A distributor
of dangerous drugs may make a sale of a dangerous drug to any of the exempted
persons listed in section
4729.541 of the Revised Code and
shall ensure the purchaser meets the exemption criteria.
(1) To confirm a purchasing prescriber meets
the exemption criteria pursuant to section
4729.541 of the Revised Code,
the drug distributor shall comply with all the following:
(a) Provide the prescriber the requirements
in Ohio law of when a prescriber is required to hold a license as a terminal
distributor of dangerous drugs;
(b)
Verify the prescriber is appropriately licensed in this state to prescribe
dangerous drugs or drug therapy related devices in the course of the
individual's professional practice;
(c) Require the prescriber who claims an
exemption to the terminal distributor of dangerous drug licensing requirement
to attest in writing, which may include an electronic signature, that the
prescriber meets the licensing exemptions in section
4729.541 of the Revised Code on
an annual basis; and
(d) Ensure
that all attestations are maintained by the drug distributor for a period of
three
five
years after the sale or distribution of the dangerous drug.
(2) To confirm any other person
purchasing dangerous drugs meets the exemption criteria pursuant to section
4729.541 of the Revised Code,
the drug distributor shall comply with all the following:
(a) Provide the person the requirements in
Ohio law of when a person is required to hold a license as a terminal
distributor of dangerous drugs;
(b)
Require the person who claims an exemption to the terminal distributor of
dangerous drug licensing requirement to attest in writing, which may include an
electronic signature, that the person meets the licensing exemptions in section
4729.541 of the Revised Code on
an annual basis; and
(c) Ensure
that all attestations are maintained by the drug distributor for a period of
three
five
years after the sale or distribution of the dangerous drug.
(E) Except as provided
in paragraph (F) of this rule, before a drug distributor located in this state
may purchase or receive dangerous drugs, the distributor shall conduct a
documented query of a roster maintained by the board to determine if the seller
is licensed as a distributor of dangerous drugs. If a licensed drug distributor
conducts a documented query at least annually and relies on the results of the
query in purchasing dangerous drugs, the distributor shall be deemed not to
have violated this rule.
(F) A
third party
third-party logistics provider is exempt from the
requirements of paragraph (B) of this rule if the licensee has access to
documentation indicating the entity responsible for directing the sale or
disposition of the drugs has complied with the requirements of this
rule.
Notes
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 4729.541, 4729.60, 3719.04, 4729.51, 4729.54
Prior Effective Dates: 10/01/1971, 03/19/1987, 07/01/1991, 03/13/1995, 01/10/1996, 03/01/1999, 01/01/2009, 10/05/2015, 03/01/2017, 03/01/2019
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