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 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 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 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
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.
Replaces: 4729-9-12
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, 1/1/09, 10/05/2015, 03/01/2017
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