Code of Massachusetts Regulations › 247 CMR - BOARD OF REGISTRATION IN PHARMACY › Title 247 CMR 2.00 - Definitions › Section 2.00 - Definitions

Current through Register 1525, July 5, 2024
Additional definitions pertaining to:
(1) nuclear pharmacies are contained in 247 CMR 13.00:
Registration Requirements and Minimal Professional Standards for Nuclear Pharmacies
;
(2) disciplinary proceedings are contained in 247 CMR 10.00:
Disciplinary Proceedings
; and
(3) continuous quality improvement programs are contained in 247 CMR 15.00:
Continuous Quality Improvement Program
; and
(4) duty to report certain factors of pharmacy operations are contained in 247 CMR 6.15:
Duty to Report Certain Factors of Pharmacy Operations
.
The following definitions apply to 247 CMR.
ACPE
means the Accreditation Council for Pharmacy Education.
ACPE-approved Provider
means an institution, organization or agency that is recognized by the ACPE, in accordance with its policies and procedures, as qualified to provide continuing education for pharmacists.
Approved College/School of Pharmacy
means a college or school of pharmacy which has been accredited by the ACPE or approved by the Board.
Authorized Provider
means a person who or agency which, sponsors or co-sponsors one or more contact hours of continuing education for pharmacists and which has received the approval of the ACPE, CME/Category 1, or the Board.
Blood
means whole blood collected from a single donor and processed, whether for transfusion or further manufacturing.
Blood Component
means that part of blood separated by physical or mechanical means.
Board
means the Massachusetts Board of Registration in Pharmacy.
Board-approved Program
means a program which has been approved by the Board for continuing education credits. Such program may be sponsored by the ACPE, and/or sponsored or cosponsored by any person who has been granted prior written approval by the Board for the particular program. The Board may, within its discretion, accept comparable continuing education hours approved by other Boards of Pharmacy.
Certificate of Approved CEUs
means a document, issued to a named pharmacist by an authorized provider, certifying that the pharmacist has satisfactorily completed a specified number of CEUs.
Certificate of Fitness
means a document issued by the Board to a pharmacy or pharmacy department which permits a pharmacy or pharmacy department to use alcohol for the manufacture of U.S. Pharmacopoeia or National Formulary preparations and all medicinal preparations unfit for beverage purposes, and to sell alcohol as authorized under M.G.L. c. 138.
Certified Pharmacy Technician
means a pharmacy technician who is currently:
(a) registered by the Board; and
(b) certified by a Board-approved certifying body.
A pharmacy technician may perform the duties authorized to be performed by a certified pharmacy technician in 247 CMR 8.04:
Certified Pharmacy Technicians
when Board-approved certification is current. If certification lapses, the individual is required to function as a pharmacy technician until certification is current.
Contact Hour
means a unit of measure of educational credit which is a minimum of 50 minutes, or the equivalent as determined by the Board, of satisfactory participation in a Board-approved program of continuing education.
Continuing Education (CE)
means participation by registered pharmacists in Board-approved educational programs and is a prerequisite for the renewal of a personal registration.
Continuing Education Unit (CEU)
means a unit of measure of educational credit which is equal to ten contact hours, or it's equivalent as determined by the Board, of satisfactory participation in a Board-approved program of continuing education.
Controlled Substance
means a drug, substance, or immediate precursor in any schedule or class referred to in M.G.L. c. 94C.
Controlled Substance Registration
means a document issued by the Board which allows the holder to receive and dispense, pursuant to a valid prescription, controlled substances.
CME/Category 1
means continuing medical education (CME) credits sponsored by an organization accredited for CME by the Accreditation Council for Continuing Medical Education, the Postgraduate Medical Institute or the state medical society.
Customer Identifier
means the identification number on a valid government issued identification, as specified by the Department, which a pharmacy obtains by inspecting the identification of the ultimate user or agent of the ultimate user to whom a prescription is dispensed. (105 CMR 700.001:
Purpose
)
Department
means the Massachusetts Department of Public Health.
Direct Supervision
means:
(a) the type of supervision a Board-approved registered pharmacist preceptor in a pharmacy, pharmacy department, or institutional pharmacy is required to provide to a pharmacy intern when said preceptor oversees and directs the professional activities of the pharmacy intern, and includes directly reviewing the work of the intern; and
(b) the type of supervision a registered pharmacist in a pharmacy, pharmacy department, hospital pharmacy, or institutional pharmacy is required to provide a pharmacy technician when said pharmacist oversees and directs the activities of the pharmacy technician.
Dispensing
means the physical act of delivering a drug, chemical, device or combination thereof to an ultimate user pursuant to the lawful order of a practitioner, as defined in M.G.L. c. 94C, § 1, including the utilization of the professional judgment of the pharmacist and the packaging, labeling, or compounding necessary to prepare the drug, chemical, or device for delivery.
Drug Sample
means a unit of a prescription drug that is not intended to be sold.
Electronically Transmitted Prescription
means an order of a practitioner which has been transmitted electronically to a pharmacy in accordance with 105 CMR 721.020:
Prescription Formats
.
Facsimile Machine (fax)
means a machine that electronically transmits exact images through connection with an electronic network.
FPGEC
means the NABP's Foreign Pharmacy Graduate Examination Committee.
FPGEC Certificate
means a document issued by the NABP evidencing the assessment of the educational equivalency of a graduate of a non-approved college/school of pharmacy.
FPGEC Certification
means the NABP's Foreign Pharmacy Graduate Examination Committee's process of documenting and assessing the educational equivalency of a graduate of a nonapproved college/school of pharmacy.
FPGEE
means the NABP's Foreign Pharmacy Graduate Equivalency Examination.
Good Moral Character
means those virtues of a person which are generally recognized as beneficial to the public health, safety and welfare.
Good Standing
means the pharmacist's personal registration is not currently being sanctioned by the Board.
Graduate of Non-approved College/School of Pharmacy
means a pharmacist whose undergraduate pharmacy degree was not conferred by an ACPE-accredited or Board-approved college/school of pharmacy yet was conferred by a recognized college/school of pharmacy outside of the United States, the District of Columbia and Puerto Rico. Recognized colleges/schools of pharmacy are those colleges and universities listed in the World Health Organization's
World Directory of Schools of Pharmacy
, or otherwise approved by the FPGEC.
Home-study and Other Mediated Instruction
means continuing education activities which do not provide for direct interaction between faculty and participants and may include audio tapes, video tapes, cable television, computer assisted instruction, journal articles and monographs.
Institutional Pharmacy
means the physical portion of an organization, including but not limited to hospitals, health maintenance organizations and clinic pharmacies, whose primary purpose is to a provide a physical environment for patients to obtain health care services under the supervision and direction of a registered pharmacist and is authorized to dispense controlled substances.
Internship
means the period of training under the supervision of a Board-approved registered pharmacist preceptor, which training is a prerequisite to examination for personal registration as a pharmacist in the Commonwealth of Massachusetts.
Legend Drug, Device or Gas
means a drug, device or gas which by federal law must bear the legend: "Caution: Federal law prohibits dispensing without prescription."
Live Program
means a continuing education program that provides for direct interaction between faculty and participants and may include, but not be limited to, lectures, symposia, live teleconferences and workshops.
Manager of Record
or
Pharmacist Manager of Record
means a pharmacist, currently registered by the Board pursuant to 247 CMR 6.07:
Pharmacist Manager of Record
, who is responsible for the operation of a pharmacy or pharmacy department in conformance with all laws and regulations pertinent to the practice of pharmacy and the distribution of drugs.
Manufacturer
means a person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging or labeling a prescription drug.
MPJE
means the Multistate Pharmacy Jurisprudence Examination.
NABP
means the National Association of Boards of Pharmacy.
NABP Number
means a unique seven digit number issued by the National Council for Prescription Drug Programs.
NAPLEX
means the North American Pharmacist Licensure Examination.
National Drug Code (NDC) Number
means a nationally recognized standard which identifies drug products using a unique number issued by the United States Food and Drug Administration. The NDC number has three components: the first component identifies the drug manufacturer ("Labeler No."); the second component identifies the product ("Product No."); and the third component identifies the package size ("Pkg.").
NCPDP
means the National Council for Prescription Drug Programs.
Over-the-counter Drug
means any drug whose availability is not restricted to an order of a practitioner.
Person
means an individual, corporation, government, governmental subdivision or agency, business trust, estate trust, partnership or association, or any other legal entity.
Personal Registration
means a document issued by the Board to a qualified pharmacist, under the provisions of M.G.L. c. 112, § 24, permitting the pharmacist to engage in the practice of pharmacy.
Pharmacy
means a facility under the direction or supervision of a registered pharmacist which is authorized to dispense controlled substances. The term "pharmacy" shall not include institutional pharmacies or pharmacy departments except as otherwise provided in 247 CMR.
Pharmacy Department
means that part of a retail store registered by the Board in which a drug business, as defined in M.G.L. c. 112, § 37, is transacted.
Pharmacy Intern
means an individual who has completed two years of academic curriculum or who has standing as a student beyond the second-year class in the undergraduate academic sequence of an approved college/school of pharmacy, and who is registered by the Board to acquire, under the direction of a Board-approved registered pharmacist preceptor to whom he or she has been assigned, that practical experience which is a prerequisite to examination for personal registration as a pharmacist. A pharmacy intern may engage in the full range of activities conducted by a registered pharmacist provided that at all time he or she is under the direct supervision of a registered pharmacist preceptor.
Pharmacy Permit
means a document issued by the Board to a registered pharmacist in the name of a pharmacy or pharmacy department to manage and operate a pharmacy or a pharmacy department.
Pharmacy Technician
means an individual who is registered by the Board, pursuant to 247 CMR 8.02:
Pharmacy Technicians
, who performs pharmacy duties under the direct supervision of a pharmacist.
Pharmacy Technician Trainee
means an individual preparing to be registered as a pharmacy technician who performs pharmacy duties under the direct supervision of a pharmacist.
Postgraduate
means graduation and award of an entry-level degree in pharmacy from a Board-approved or ACPE-accredited college/school of pharmacy.
Practitioner
means any person with prescriptive privileges as defined in M.G.L. c. 94C, § 1.
Preceptor
means a registered pharmacist in good standing who has completed at least one year of the actual practice of pharmacy and who the Board has approved to supervise and direct the training of pharmacy interns and to assist in the training of other pharmacy interns.
Prescription
means an order for a drug, chemical, device or combination thereof, either written, given orally or otherwise transmitted to a registered pharmacy by a practitioner or his or her expressly authorized agent, to be dispensed or compounded in a registered pharmacy and dispensed by a registered pharmacist to a patient or his or her agent with necessary and appropriate counseling.
Prescription Drug
means any and all drugs which, under Federal Law, are required, prior to being dispensed or delivered, to be labeled with the statement "Caution, Federal law prohibits dispensing without prescription" or a drug which is required by any applicable Federal or State law or regulation to be dispensed pursuant only to a prescription drug order.
Prescription Device
means an instrument, apparatus, implement, machine, contrivance, implant, or other similar related article, including any component part or accessory, which is required by federal law and regulations to bear the label, "Caution, Federal law prohibits dispensing without prescription" or a device which is required by any applicable Federal or State law or regulation to be dispensed pursuant only to a prescription order.
Program
means an educational course, lecture, seminar, conference, session or exercise.
Registered Pharmacist (R.Ph.)
means a pharmacist who, pursuant to the provisions of M.G.L. c. 112, § 24, is registered by the Board to practice pharmacy.
Restricted Pharmacy
means a pharmacy licensed by the Board for the limited transaction of a drug business as defined in M.G.L. c. 112, § 37.
Universal Claim Form (UCF)
means a nationally recognized standard form developed by the NCPDP used for billing prescription drug claims to insurance plans. Universal Claim Forms are available through a pharmacy's local wholesaler.
Wholesale Distribution
means distribution of prescription drugs and prescription devices to persons other than a consumer or patient, but does not include:
(a) Intracompany sales;
(b) the purchase or other acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a drug or device for its own use from the group purchasing organization or from other hospitals or healthcare entities that are members of such organizations;
(c) the sale, purchase or trade of a drug or device or an offer to sell, purchase or trade a drug by a charitable organization described in section 501(c)(3) of the Internal Revenue Code of 1954 to a nonprofit affiliate of the organization to the extent otherwise permitted by law; (d) the sale, purchase or trade of a drug or device or an offer to sell, purchase or trade a drug or device among hospitals or other health care entities that are under common control; for purposes of 247 CMR 7.00, "common control" means that power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, by contract or otherwise;
(e) the sale, purchase or trade of a drug or device or an offer to sell, purchase, or trade a drug or device for emergency medical reasons; for purposes of 247 CMR 7.00, "emergency medical reasons" includes transfers of prescription drugs or devices by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage;
(f) the sale, purchase or trade of a drug or device, an offer to sell, purchase or trade a drug or device, or the dispensing of a drug or device pursuant to a prescription;
(g) the lawful distribution of drug samples by manufacturers' representatives or distributors' representatives; or
(h) the sale, purchase or trade of blood and blood components intended for transfusion.
Wholesale Distributor
means a person engaged in wholesale distribution of prescription drugs or devices including, but not limited to, manufacturers; repackers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies that conduct wholesale distributions.