Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 1 - GENERAL PROVISIONS › Section R. 338.501 - Definitions

Current through Vol. 24-12, July 15, 2024
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.