Law Definitions Exam 2

Class

lists of controlled substances for the purpose of determining the severity of criminal offenses under this chapter

schedule

the list of controlled substances established by the commissioner pursuant to the provisions of section two for purposes of administration and regulation

administer

The direct application of a controlled substance whether by injection, inhalation, ingestion, or any other means to the body of a patient or research subject by a practitioner or nurse (at the direction of a practitioner) or a registered pharmacist or ultimate user or research subject

controlled substance

A drug, substance, controlled substance analogue or immediate precursor on any schedule or class referred to in this chapter

counterfeit substance

A substance which is represented to be a particular controlled drug or substance, but which is in fact not that drug or substance

deliver

To transfer, whether by actual or constructive transfer, a controlled substance from one person to another, whether or not there is an agency relationship

dispense

to deliver a controlled substance to an ultimate user or research subject or to the agent of an ultimate user or research subject by a practitioner or pursuant to the order of a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling, or compounding necessary for such delivery

distribute

to deliver other than by administering or dispensing a controlled substance. ''Drug'', (a) substances recognized as drugs in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them; (b) substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; (c) substances, other than food, intended to affect the structure, or any function of the body of man and animals; or (d) substances intended for use as a component of any article specified in clauses (a), (b) or (c), exclusive of devices or their components, parts or accessories.

electronic prescription

a lawful order from a practitioner for a drug or device for a specific patient that is generated on an electronic prescribing system that meets federal requirements for electronic prescriptions for controlled substances, and is transmitted electronically to a pharmacy designated by the patient without alteration of the prescription information, except that third-party intermediaries may act as conduits to route the prescription from the prescriber to the pharmacist;

extended release long acting opioid in a non- abuse deterrent form

a drug that is: (i) subject to the United States Food and Drug Administration's extended release and long-acting opioid analgesics risk evaluation and mitigation strategy; (ii) an opioid approved for medical use that does not meet the requirements for listing as a drug with abuse deterrent properties pursuant to section 13 of chapter 17; and (iii) identified by the drug formulary commission pursuant to said section 13 of said chapter 17 as posing a heightened level of public health risk.

manufacture

the production, preparation, propagation, compounding, conversion or processing of a controlled substance, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, including any packaging

narcotic drug

any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis: (a) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate;

Narcotic Drug

any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

(a) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate;

(b) Any salt, compound, isomer, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in clause (a), but not including the isoquinoline alkaloids of opium;

(c) Opium poppy and poppy straw;

(d) Coca leaves and any salt, compound, derivative, or preparation of coca leaves, and any salt, compound, isomer, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, but not including decocainized coca leaves or extractions of coca leaves which do not contain cocaine or ecgonine.

oral prescription

an oral order for medication which is dispensed to or for an ultimate user, but not including an order for medication which is dispensed for immediate administration to the ultimate user by a practitioner, registered nurse, or practical nurse.

Outsourcing facility

an entity at 1 geographic location or address that: (i) is engaged in the compounding of sterile drug preparations; (ii) has registered with the federal Food and Drug Administration as an outsourcing facility pursuant to 21 U.S.C. section 353b; and (iii) has registered with the board of registration in pharmacy pursuant to section 36E of chapter 112.

pharmacist

any pharmacist registered in the commonwealth to dispense controlled substances, and including any other person authorized to dispense controlled substances under the supervision of a pharmacist registered in the commonwealth.

pharmacy

a facility under the direction or supervision of a registered pharmacist which is authorized to dispense controlled substances, including but not limited to ''retail drug business'' as defined below.

physician assistant

a person who is a graduate of an approved program for the training of physician assistants who is supervised by a registered physician

practioner

a) A physician, dentist, veterinarian, podiatrist, scientific investigator, or other person registered to distribute, dispense, conduct research with respect to, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research in the commonwealth; (b) A pharmacy, hospital, or other institution registered to distribute, dispense, conduct research with respect to or to administer a controlled substance in the course of professional practice or research in the commonwealth. (c) An optometrist authorized by sections 66 and 66B of chapter 112 and registered pursuant to paragraph (h) of section 7 to utilize and prescribe therapeutic pharmaceutical agents in the course of professional practice in the commonwealth. ''Prescription drug'', any and all drugs upon which the manufacturer or distributor has, in compliance with federal law and regulations, placed the following: ''Caution, Federal law prohibits dispensing without prescription''

Prescription Drug

any and all drugs upon which the manufacturer or distributor has, in compliance with federal law and regulations, placed the following: ''Caution, Federal law prohibits dispensing without prescription''.

registrant

a person who is registered pursuant to any provision of this chapter.

registration

unless the context specifically indicates otherwise, such registration as is required and permitted only pursuant to the provisions of this chapter

registration number

such registration numbers or numbers, either federal or state, that are required with respect to practitioners by appropriate administrative agencies.

retail drug business

a store for the transaction of ''drug business''

ultimate user

a person who lawfully possesses a controlled substance for his own use or for the use of a member of his household or for the use of a patient in a facility licensed by the department

written prescription

a lawful order from a practitioner for a drug or device for a specific patient that is communicated directly to a pharmacist in a licensed pharmacy; provided, however, it shall not include an order for medication which is dispensed for immediate administration to the ultimate user by a practitioner, registered nurse or licensed practical nurse.

drug

(a) substances recognized as drugs in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them;

(b) substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals;

(c) substances, other than food, intended to affect the structure, or any function of the body of man and animals; or

(d) substances intended for use as a component of any article specified in clauses (a), (b) or (c), exclusive of devices or their components, parts or accessories.

ACPE

Accreditation Council for Pharmacy Education.

ACPE-approved Provider

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

a college or school of pharmacy which has been accredited by the ACPE or approved by the Board.

Authorized Provider

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

whole blood collected from a single donor and processed, whether for transfusion or further manufacturing

Blood Component

that part of blood separated by physical or mechanical means

Board

the Massachusetts Board of Registration in Pharmacy.

Board-approved Program

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

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

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

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

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)

participation by registered pharmacists in Board-approved educational programs and is a prerequisite for the renewal of a personal registration.

Continuing Education Unit (CEU)

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

a drug, substance, or immediate precursor in any schedule or class referred to in M.G.L. c. 94C.

Controlled Substance Registration

a document issued by the Board which allows the holder to receive and dispense, pursuant to a valid prescription, controlled substances.

CME/Category 1

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

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.

Department

the Massachusetts Department of Public Health.

Direct Supervision

(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

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

a unit of a prescription drug that is not intended to be sold.

Electronically Transmitted Prescription

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)

a machine that electronically transmits exact images through connection with an electronic network.

FPGEC

the NABP's Foreign Pharmacy Graduate Examination Committee.

FPGEC Certificate

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

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.

Good Moral Character

those virtues of a person which are generally recognized as beneficial to the public health, safety and welfare.

Good Standing

the pharmacist’s personal registration is not currently being sanctioned by the Board.

Graduate of Non-approved College/School of Pharmacy

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

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

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."

MPJE

the Multistate Pharmacy Jurisprudence Examination

NABP

the National Association of Boards of Pharmacy

NABP Number

a unique seven digit number issued by the National Council for Prescription Drug Programs

NCPDP

the National Council for Prescription Drug Programs

Restricted Pharmacy

a pharmacy licensed by the Board for the limited transaction of a drug business

Universal Claim Form (UCF)

a nationally recognized standard form developed by the NCPDP used for billing prescription drug claims to insurance plans. They are available through a pharmacy's local wholesaler.