Mich. Admin. Code R. 338.533 - Compounding standards and requirements; outsourcing facilities; requirements
Rule 33.
(1)
The board approves and adopts by reference the compounding standards of USP,
published by the United States Pharmacopeial Convention, 12601 Twinbrook
Parkway, Rockville, Maryland 20852-1790. This includes USP Chapters 795
(revised 2023) and 797 (revised 2023), with the exception of
flavoring.
(2) The standards adopted
by reference in subrule (1) of this rule are available at a cost of $250.00 at
http://www.usp.org/compounding, or
can be viewed at the Bureau of Professional Licensing, Michigan Department of
Licensing and Regulatory Affairs, Ottawa Building, 611 West Ottawa, P.O. Box
30670, Lansing, Michigan 48909.
(3)
A pharmacy that provides compounding services shall comply with the standards
adopted in subrule (1) of this rule.
(4) An outsourcing facility located outside
of this state that dispenses, provides, distributes, or otherwise furnishes
compounded pharmaceuticals in this state shall be inspected and registered as
an outsourcing facility by the FDA before applying for a pharmacy license in
this state.
(5) An outsourcing
facility located within this state that is applying for licensure as a pharmacy
shall complete both of the following:
(6) An outsourcing facility shall do all of
the following:
(a) Compound drugs by or under
the supervision of a licensed pharmacist.
(b) Compound drugs under current good
manufacturing practices for finished pharmaceuticals set forth in
21 CFR
211.1 to
211.208.
(c) Ensure that a pharmacist who conducts or
oversees compounding at an outsourcing facility is proficient in the practice
of compounding and has acquired the education, training, and experience to
maintain that proficiency by doing any of the following:
(i) Participating in seminars.
(ii) Studying appropriate
literature.
(iii) Consulting with
colleagues.
(iv) Being certified by
a compounding certification program approved by the board.
(d) Label compounded drugs and compounded
drugs that are patient specific in compliance with the requirements in
R 338.582 and include all of the
following:
(i) Required drug and ingredient
information.
(ii) Facility
identification.
(iii) The following
or similar statement: "This is a compounded drug. For office use only" or "Not
for resale."
(e) Ensure
that bulk drug substances used for compounding meet specified FDA
criteria.
(7) An
outsourcing facility may compound drugs that appear on an FDA shortage list, if
the bulk drug substances used to compound the drugs comply with the criteria
specified in this rule.
Notes
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