Mich. Admin. Code R. 338.532 - Sterile compounding accrediting organizations; board approval; inspection entities
Rule 32.
(1)
The board shall approve, under section 17748a of the code, MCL
333.17748a, accrediting
organizations or inspection entities for pharmacies that compound
pharmaceuticals according to standards adopted by reference in
R 338.533.
(2) The department shall post on its website,
the list of organizations approved under subrule (1) of this rule.
(3) An organization may petition the board
for approval under subrule (1) of this rule. The petition must include, but is
not limited to, all of the following:
(a)
Requirements for accreditation or compliance.
(b) Requirements for inspectors.
(c) Training provided to
inspectors.
(d) Copy of the most
current inspection form.
(e) The
length of accreditation.
(f)
Agreement and plan to share results of inspections with the
department.
(4) If the
board approves the petition, the approval is valid for 3 years after the date
of approval. The organization may submit a petition that complies with subrule
(3) of this rule to seek continuing approval.
(5) The board may rescind approval of an
organization upon just cause. The rescission will not immediately affect the
compliance of a pharmacy using the accreditation. Within 12 months after the
rescission date or by the next licensure renewal date, whichever is later, the
accreditation is void, and a pharmacy shall obtain accreditation or an
inspection from an organization that satisfies subrule (1) of this
rule.
Notes
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