Effective April 1, 2015, ORC 4729.541 will require the following
business entities to hold a license as a terminal distributor of
dangerous drugs in order to possess, have custody or control of,
and distribute dangerous drugs that are compounded or used
for the purpose of compounding:
(1) A business entity that is a corporation formed under division
(B) of section 1701.03 of the Revised Code, a limited liability
company formed under Chapter 1705. of the Revised Code, or a
professional association formed under Chapter 1785. of the
Revised Code if the entity has a sole shareholder who is a
licensed health professional authorized to prescribe drugs and is
authorized to provide the professional services being offered by
the entity; or
(2) A limited liability company, a partnership or a limited liability
partnership, or a professional association, if, to be a shareholder,
member, or partner, an individual is required to be licensed,
certified, or otherwise legally authorized under Title 47 of the
Revised Code to perform the professional service provided by the
entity and each such individual is a licensed health professional
authorized to prescribe drugs.
Please note: a physician who practices as a sole
proprietor under their medical license is still exempt from
licensure as a terminal distributor of dangerous drugs.
Please note: If you already have a terminal distributor of
dangerous drugs license, this law change does not apply
to you.
To assist with the implementation of this change, the Ohio State
Board of Pharmacy has developed and updated a frequently
asked questions document, which can be accessed here:
www.pharmacy.ohio.gov/CompoundingTDDD
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