Mich. Admin. Code R. 338.501

Current through Vol. 24-18, October 15, 2024

Section 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.

Mich. Admin. Code R. 338.501

2020 AACS; 2022 AACS; 2024 MR 5, Eff. 2/29/2024