Mich. Admin. Code R. 338.501 - Definitions
Rule 1.
(1) As
used in these rules:
(a) "ACPE" means
Accreditation Council for Pharmacy Education.
(b) "Approved education program" means a
school of pharmacy that is accredited by or has candidate status by the
ACPE.
(c) "Board" means the
Michigan board of pharmacy, created in section 17721 of the code, MCL
333.17721.
(d) "Code" means the public health code, 1978
PA 368, MCL
333.1101 to
333.25211.
(e) "Compounding" means the preparation,
mixing, assembling, packaging, and labeling of a drug or device by a pharmacist
under any of the following circumstances:
(i)
On receipt of a prescription for a specific patient.
(ii) On receipt of a medical or dental order
from a prescriber or agent for use in the treatment of patients within the
course of the prescriber's professional practice.
(iii) In anticipation of the receipt of a
prescription or medical or dental order based on routine, regularly observed
prescription, or medical or dental order patterns.
(iv) For the purpose of or incidental to
research, teaching, or chemical analysis and not for the purpose of sale or
dispensing.
(f)
"Compounding" does not include any of the following:
(i) Except as provided in section 17748c of
the code, MCL
333.17748c, the compounding of a
drug product that is essentially a copy of a commercially available
product.
(ii) The reconstitution,
mixing, or other similar act that is performed under the directions contained
in approved labeling provided by the manufacturer of a commercially available
product.
(iii) The compounding of
allergenic extracts or biologic products.
(iv) Flavoring agents added to conventionally
manufactured and commercially available liquid medications. Flavoring agents
must be nonallergenic and inert, not exceeding 5% of a drug product's total
volume.
(g) "CPMP" means
customized patient medication package that is prepared by a pharmacist for a
specific patient and contains 2 or more prescribed solid oral dosage
forms.
(h) "DEA" means the Federal
Drug Enforcement Administration.
(i) "Department" means the department of
licensing and regulatory affairs.
(j) "Electronic signature" means an
electronic sound, symbol, or process attached to or logically associated with a
record and executed or adopted by an individual with the intent to sign the
record. An electronic signature is a unique identifier protected by appropriate
security measures that is only available for use by the intended individual and
ensures non-repudiation so that the signature may not be rejected based on its
validity.
(k) "Error prevention
technology" means machinery and equipment used in a pharmacy setting to reduce
dispensing medication errors including, but not limited to, barcode
verification and radio frequency identification.
(l) "FDA" means the United States Food and
Drug Administration.
(m) "FEIN"
means a federal employer identification number.
(n) "FPGEC" means the Foreign Pharmacy
Graduate Examination Committee.
(o)
"GED" means a general education development certificate.
(p) "Manual signature" means a signature that
is handwritten or computer-generated if a prescription is electronically
transmitted, as that term is defined in section 17703 of the code, MCL
333.17703.
(q) "NABP" means the National Association of
Boards of Pharmacy.
(r) "NABP-VPP"
means the NABP Verified Pharmacy Program.
(s) "NAPLEX" means the North American
pharmacist licensure examination.
(t) "PIC" means pharmacist in
charge.
(u) "Practical experience"
means professional and clinical instruction in, but not limited to, all of the
following areas:
(i) Pharmacy administration
and management.
(ii) Drug
distribution, use, and control.
(iii) Legal requirements.
(iv) Providing health information services
and advising patients.
(v)
Pharmacist's ethical and professional responsibilities.
(vi) Drug and product information.
(vii) Evaluating drug therapies and
preventing or correcting drug-related issues.
(v) "USP" means the United States
Pharmacopeia.
(w) "Virtual
manufacturer" means a person who engages in the manufacture of prescription
drugs or devices and meets all of the following:
(i) Owns either of the following:
(A) The new prescription drug application or
abbreviated new prescription drug application number.
(B) The unique device identification number,
as available, for a prescription device.
(ii) Contracts with a contract manufacturing
organization for the physical manufacture of the drugs or devices.
(iii) Is not involved in the physical
manufacture of the drugs or devices.
(iv) At no time takes physical possession of
or stores the drugs or devices.
(v)
Sells or offers for sale to other persons, for resale, compounding, or
dispensing of, drugs or devices, salable on prescription only.
(x) "Written" includes both paper
and electronic forms.
(2)
Unless otherwise defined in these rules, the terms defined in the code have the
same meaning as used in these rules.
Notes
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