247 CMR: BOARD OF REGISTRATION IN PHARMACY
247 CMR 2.00:DEFINITIONS AND SEVERABILITY
Section
2.00Definitions
2.01:General
2.02:Definitions
2.03:Severability
2.00: Definitions
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.
2.01:General
(1)Definitions specific to nuclear pharmacy practice are contained in 247 CMR 13.00.
(2)The following definitionsin this chapter apply tothroughout 247 CMR 2.00 et seq., unless otherwise specified.
2.02:Definitions
Above Action Level Environmental Monitoring Result means results of viable and nonviable testing that exceed levels described in 247 CMR 17.XX.
Accreditation means a process by which a professional association or non-governmental agency grants recognition or certification to a pharmacy for demonstrated ability to meet certain pre-defined criteria.
ACPEmeans the Accreditation Council for PharmacyEducation.
ACPE-approvedProvidermeansaninstitution,organization,oragencythatisrecognizedbythe ACPE,inaccordancewithitspoliciesandprocedures,asqualifiedtoprovidecontinuing education for pharmacists.
Applicant means any person or entity that applies to the Board for a license to operate a pharmacy. In the case of an applicant which is not a natural personan individual, each of the following individuals shall be deemed an applicant: any individual owning 5% or more; any officer and any director of any corporate applicant; any limited partner owning 5% or more and any general partner of any partnership applicant; any trustees of any trust applicant; any sole proprietor of any applicant which is a sole proprietorship; any mortgagee in possession; and any executor or administrator of any applicant which is an estate.
ApprovedCollege/SchoolofPharmacymeansacollegeorschoolofpharmacywhichhasbeen accredited bythe ACPE or approved bythe Board.
Authorized Pharmacist means a pharmacist who:
(a)is currently registered by the Board and in good standing;
(b)meets the requirements of 247 CMR 16.02; and
(c)is participating in drug therapy management with a supervising physician pursuant to a written CDTM agreement with written protocols.
AuthorizedProvidermeansapersonwhooragencywhich,sponsorsorco-sponsorsoneormore contacthoursofcontinuingeducationforpharmacistsandwhichhas receivedtheapprovalof the ACPE, CME/Category1, or the Board.
Bloodmeanswholebloodcollectedfromasingledonorandprocessed,whetherfortransfusion orfurther manufacturing.
(Blood Componentmeansthat partofbloodseparatedbyphysical ormechanical means.
Board means the Massachusetts Board of Registration in Pharmacy.
Board-approvedProgrammeansaprogramwhichhasbeenapprovedbytheBoardforcontinuing educationcredits.SuchprogrammaybesponsoredbytheACPE,and/orsponsoredorcosponsoredbyanypersonwhohasbeengrantedpriorwrittenapprovalbytheBoardforthe particularprogram.TheBoardmay,withinitsdiscretion,acceptcomparablecontinuing education hours approved byotherBoards ofPharmacy.
CDTM referral means the individual patient referral by a supervising physician to an authorized pharmacist for the purpose of receiving CDTM services in a community pharmacy setting. In other practice settings, “referral” means the consultation of a supervising physician and an authorized pharmacist about a patient for the purpose of receiving CDTM services. In accordance with 243 CMR 2.12, the supervising physician shall execute a written CDTM referral which shall include, but not be limited to, the patient’s name and address, the primary diagnosis for which CDTM services are authorized, the diagnosis of any co-morbid conditions for which CDTM services are authorized, any known patient drug allergies, a statement that the patient has executed a written consent to CDTM services and any other specific instructions to the authorized pharmacist.
CertificateofApprovedCEUsmeansadocument,issuedtoanamedpharmacistbyan authorizedprovider,certifyingthatthepharmacisthassatisfactorilycompletedaspecified 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 PharmacyTechnician meansapharmacytechnicianwhoiscurrently:
(a)registered bythe Board; and
(b)certified byaBoard-approved certifyingbody.
Apharmacytechnicianmayperformthedutiesauthorizedtobeperformedbyacertified pharmacytechnicianin247CMR8.04:CertifiedPharmacyTechnicianswhenBoard-approved certificationiscurrent.Ifcertificationlapses,theindividualisrequiredtofunctionasa pharmacytechnicianuntilcertification iscurrent.
Collaborative Drug Therapy Management (CDTM) means the initiating, monitoring, modifying, and discontinuing of a patient’s drug therapy by an authorized pharmacist under the supervision of a physician in accordance with a collaborative practice agreement. Collaborative drug therapy management may include: collecting and reviewing patient histories; obtaining and checking vital signs, including pulse, temperature, blood pressure, and respiration; and, under the supervision of, or in direct consultation with, a physician, ordering and evaluating the results of laboratory tests directly related to drug therapy when performed in accordance with approved protocols applicable to the practice setting and when the evaluation shall not include a diagnostic component.
Community pharmacy means a pharmacy that holds a drug store pharmacy license.
ContactHourmeansaunitofmeasureofeducationalcreditwhichisaminimumof5060minutes, ortheequivalentasdeterminedbytheBoard,ofsatisfactoryparticipationinaBoard-approved program of continuing education.
ContinuingEducation (CE) means participation byregistered pharmacists in Board-approved educational programs and is aprerequisite for therenewal of apersonal registration.
Continuous Quality Improvement Program (CQI Program) means a system of standards and procedures to identify and evaluate quality related events and improve patient care.
ContinuingEducationUnit(CEU)meansaunitofmeasureofeducationalcreditwhichisequal totencontacthours,orit'sequivalent as determined bytheBoard,ofsatisfactoryparticipation in a Board-approved program of continuing education.
ControlledSubstancemeansadrug,substance,orimmediateprecursorinanyscheduleorclass referred toinM.G.L.c.94C.
ControlledSubstanceRegistrationmeansadocumentissuedbytheBoardwhichallowsthe holdertoreceiveanddispense,pursuanttoavalidprescription,controlledsubstances.
CME/Category1meanscontinuingmedicaleducation(CME)creditssponsoredbyan organizationaccreditedforCMEby theAccreditationCouncilforContinuingMedical Education, the PostgraduateMedical Instituteorthestatemedical society.
CustomerIdentifiermeanstheidentificationnumberonavalidgovernmentissuedidentification, asspecifiedbytheDepartment,whichapharmacyobtainsbyinspectingtheidentificationofthe ultimateuseroragentoftheultimateusertowhomaprescriptionisdispensed.(105CMR 700.001:Purpose)
Department means the Massachusetts Department ofPublic Health.
Direct Supervision means:
(a)contemporaneous observation and direction of the activities of a pharmacy intern, pharmacy technician, or technician in training; and
(b)a preceptor or supervisor is responsible for the actions of a pharmacy intern, pharmacy technician, or technician in training while that intern or technician is acting within his or her scope of practice, Board regulations, and the policies and procedures of the facility.
(a)the type of supervision a Board-approved registered pharmacist preceptor in a 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.
Dispensingmeansthephysicalactofdeliveringadrug,chemical,deviceorcombinationthereof toanultimate user pursuant to thelawful order of a practitioner, asdefinedin M.G.L.c.94C, §1,includingtheutilizationoftheprofessionaljudgmentofthepharmacistandthepackaging, labeling, or compoundingnecessaryto preparethedrug, chemical, ordevice fordelivery.
Disciplinary Action means an action including, suspension, probation, censure, reprimand, or restriction of the license to operate a pharmacy or practice pharmacy, denial of application for renewal, denial or restriction of privileges or termination from Medicare or Medicaid programs including any adverse actions or fines imposed by a state or federal agency.
DrugSamplemeansa unitofaprescriptiondrugthatisnotintendedtobe sold.
ElectronicallyTransmittedPrescriptionmeansanorderofapractitionerwhichhasbeen transmittedelectronicallytoapharmacyinaccordance with105CMR721.020: PrescriptionFormats.
Federal Agency means any U.S. Government agency that has regulatory purview over the clinical practice of pharmacy or of pharmacy operations, including, but not limited to, all agencies in the U.S. Department of Health and Human Services, the U.S. Occupational Safety and Health Administration, and the U.S. Department of Justice.
FacsimileMachine(fax)meansamachinethatelectronicallytransmitsexactimagesthrough connection with an electronic network.
FPGEC means theNABP's Foreign PharmacyGraduate Examination Committee.
FPGECCertificatemeansadocumentissuedbytheNABPevidencingtheassessmentofthe educational equivalencyofagraduateofanon-approved college/school ofpharmacy.
FPGECCertificationmeanstheNABP’sForeignPharmacyGraduateExaminationCommittee’s processofdocumentingandassessingtheeducationalequivalencyofagraduateofanon- approved college/school ofpharmacy.
FPGEE means the NABP’s Foreign PharmacyGraduate EquivalencyExamination.
GoodMoralCharactermeansthosevirtuesofapersonwhicharegenerallyrecognizedas beneficial to the public health, safetyand welfare.
GoodStandingmeans athepharmacist’spersonalregistrationlicense or registrationis active or retired andnotcurrentlybeingsanctionedbythe Boardnot on probation,suspended, surrendered or revoked.
GraduateofNon-approvedCollege/SchoolofPharmacymeansapharmacistwhose undergraduatepharmacydegreewasnotconferred byanACPE-accreditedor Board-approved college/schoolofpharmacyyetwasconferredbyarecognizedcollege/schoolofpharmacy outsideoftheUnitedStates,theDistrictofColumbiaandPuertoRico.Recognized colleges/schoolsofpharmacyarethosecollegesanduniversitieslistedintheWorldHealth Organization’sWorldDirectoryofSchoolsofPharmacy,orotherwiseapprovedbytheFPGEC.
Home-studyandOtherMediatedInstructionmeanscontinuingeducationactivitieswhichdonot providefordirectinteraction in real timebetweenfacultyandparticipantsandmayinclude paper or digital format. audiotapes, video tapes, cabletelevision,computerassisted instruction,journalarticles,andmonographs.
Improper dispensing of a prescription drug means the incorrect dispensing of a prescribed medication that is received by a patient.
InstitutionalPharmacymeansa pharmacy located in a hospital or clinic that does not hold a drug store pharmacy license or an institutional sterile compounding pharmacy license. thephysicalportionofanorganization,includingbutnotlimited tohospitals,healthmaintenanceorganizations,andclinicpharmacies,whoseprimarypurposeis toaprovideaphysicalenvironmentforpatientstoobtainhealthcareservicesunderthe supervisionanddirectionofaregisteredpharmacistandisauthorizedtodispensecontrolled substances.
Interest holder means (1) individual who is the immediate family member of the applicant or licensee; (2) individual who is not an applicant or licensee but who has a financial interest in the pharmacy; or (3) individual who operates a substantial amount of control over the operation of the pharmacy.
InternshipmeanstheperiodoftrainingunderthesupervisionofaBoard-approvedregistered pharmacist preceptor, whichtrainingis aprerequisiteto examination for personal registration asapharmacistintheCommonwealthofMassachusetts.
LegendDrug,DeviceorGasmeansadrug,deviceorgaswhichbyfederallawmustbearthe legend: "Caution: Federal lawprohibits dispensing without prescription."
Licensee means any person or entity holding a license to operate a pharmacy. In the case of a licensee which is not a natural person, each of the following individuals shall deemed a licensee: any individual owning five percent or more, any officer, and any director of any corporate licensee; any limited partner owning 5% or more and any general partner of a partnership licensee; any trustee of any trust licensee; any sole proprietor of any licensee which is a sole proprietorship; any mortgagee in possession and any executor or administrator of any licensee which is an estate.
LiveProgrammeansacontinuingeducationprogramthatprovidesfordirectinteraction in real timebetween facultyandparticipantsandmayinclude,butnotbelimitedto,lectures,symposia,live teleconferencesandworkshops.
ManagerofRecordorPharmacistManagerofRecordmeansapharmacist,currentlyregistered bytheBoardpursuantto247CMR6.07:PharmacistManagerofRecord, who isresponsible fortheoperationofapharmacyorpharmacydepartmentinconformancewithalllawsand regulationspertinentto thepracticeofpharmacyandthedistributionofdrugs.
Manufacturermeansapersonwhoisengagedinmanufacturing,preparing,propagating, compounding, processing, packaging, repackagingorlabelingaprescription drug.
MassHealthmeans the Medical assistance program known as MassHealth administered by the Executive Office of Health and Human Services pursuant to M.G.L. c. 118E and Title XIX of the Social Security Act.
MPJE means the Multistate PharmacyJurisprudence Examination.
NABPmeans the National Association ofBoards ofPharmacy.
NABPNumbermeansauniquesevendigitnumberissuedbytheNationalCouncilfor PrescriptionDrugPrograms.
NAPLEX means the North American Pharmacist LicensureExamination.
NationalDrugCode(NDC)Numbermeansanationallyrecognizedstandardwhichidentifies drugproductsusingauniquenumberissuedbytheUnitedStatesFoodandDrugAdministration. The NDC number has three components:the first component identifies the drugmanufacturer ("LabelerNo.");thesecondcomponentidentifiestheproduct("ProductNo.");andthethird component identifies the package size ("Pkg.").
NCPDPmeans theNational Council for Prescription DrugPrograms.auniquesevendigitnumberissuedbytheNationalCouncilfor PrescriptionDrugPrograms.
Outsourcing facility means an entity at one geographic location or address that: (i) is engaged in the compounding of sterile drug preparations; and (ii) has registered with the federal Food and Drug Administration, FDA, as an outsourcing facility pursuant to 21 U.S.C. section 353b.
Over-the-counterDrugmeansanydrugwhoseavailabilityisnotrestrictedtoanorderofa practitioner.a drug that is available for purchase without a prescription.
Personmeansanindividual,corporation,government,governmentalsubdivisionoragency, business trust, estatetrust, partnership or association, or anyotherlegal entity.
PersonalRegistrationmeansa documentissuedbytheBoardtoa qualifiedpharmacist,under theprovisionsofM.G.L.c.112,§24,permittingthepharmacisttoengageinthepracticeof pharmacy.
Pharmacymeansafacility licensed by the Board andunderthedirectionorsupervisionofaregisteredpharmacistwhich isauthorizedtodispensecontrolledsubstances. Theterm"pharmacy"includes drug store pharmacies, sterile compounding pharmacies, complex non-sterile compounding pharmacies, institutional sterile compounding pharmacies, non-resident pharmacies, non-resident sterile compounding pharmacies, and non-resident complex non-sterile compounding pharmacies. shallnotinclude institutional pharmaciesorpharmacydepartmentsexceptasotherwiseprovided in247 CMR.
PharmacyDepartmentmeansthatpartofaretailstoreregisteredbytheBoardinwhichadrug business, as defined in M.G.L. c. 112, § 37, is transacted.
PharmacyInternmeansanindividualwhohascompletedtwoyearsofacademiccurriculumor whohasstandingasastudentbeyondthesecond-yearclassintheundergraduateacademic sequenceofanapprovedcollege/schoolofpharmacy,andwhoisregisteredbytheBoardto acquire,underthedirectionofaBoard-approvedregisteredpharmacistpreceptortowhomheor shehasbeenassigned,thatpracticalexperiencewhichisaprerequisitetoexaminationfor personalregistrationasapharmacist.Apharmacyinternmayengageinthefullrangeof activitiesconductedbyaregisteredpharmacistprovidedthatatalltimeheor sheisunderthe direct supervision of a registered pharmacist preceptor.
PharmacyPermitmeansadocumentissuedbytheBoardtoaregisteredpharmacistinthename ofapharmacyorpharmacydepartmenttomanageandoperateapharmacyorapharmacy department.
PharmacyTechnicianmeansanindividualwhoisregisteredbytheBoard,pursuantto247CMR 8.02:PharmacyTechnicians,whoperformspharmacydutiesunderthedirectsupervisionofa pharmacist.
PharmacyTechnicianTraineemeansanindividualpreparingtoberegisteredasapharmacy technicianwhoperformspharmacydutiesunderthedirect supervisionofapharmacist.
Postgraduatemeans graduationandawardof anentry-level degreein pharmacyfromaBoard- approved or ACPE-accredited college/school of pharmacy.
Practitioner means anyperson with prescriptive privileges as defined in M.G.L. c. 94C, § 1. Preceptormeansaregisteredpharmacistingoodstandingwhohascompletedatleastone yearoftheactualpracticeofpharmacyandwhotheBoardhasapprovedtosuperviseanddirectthetrainingofpharmacyinternsandtoassistin thetrainingofotherpharmacyinterns.
Prescriptionmeansanorderforadrug,chemical,deviceorcombinationthereof,eitherwritten, givenorally orotherwisetransmittedtoaregisteredpharmacyby apractitionerorhisorher expresslyauthorizedagent,tobedispensedorcompoundedinaregisteredpharmacyand dispensedbyaregisteredpharmacisttoapatientorhisorheragentwithnecessaryand appropriatecounseling.
PrescriptionDrugmeansanyandalldrugswhich,underFederalLaw,arerequired,priorto beingdispensedordelivered,tobelabeled withthestatement “Caution, Federal lawprohibits dispensingwithoutprescription"oradrugwhichisrequiredbyanyapplicableFederalorState law or regulation to be dispensed pursuant onlyto a prescription drugorder.
PrescriptionDevicemeansaninstrument,apparatus,implement,machine,contrivance,implant, orothersimilarrelatedarticle,includinganycomponentpartoraccessory,whichisrequiredby federallawandregulationstobearthelabel,“Caution,Federallawprohibitsdispensingwithout prescription”oradevicewhichisrequiredbyanyapplicableFederalorStatelaworregulation to be dispensed pursuant onlyto a prescription order.
Program means an educational course, lecture, seminar, conference, session or exercise.
Quality Related Event (QRE) means the incorrect dispensing of a prescribed medication that is received by a patient, including:
(a)a variation from the prescriber’s prescription order, including but not limited to:
1.dispensing an incorrect drug;
2.dispensing an incorrect drug strength;
3.dispensing an incorrect dosage form;
4.dispensing a drug to the wrong patient;
5.providing inadequate or incorrect packaging, labeling, or directions; or
6.dispensing an incorrect quantity of medication.
(b)a failure to identify and manage:
1.over-utilization;
2.therapeutic duplication;
3.drug-disease contraindications;
4.drug-drug interactions;
5.incorrect drug dosage or duration of drug treatment;
6.drug-allergy interactions; or
7.clinical abuse or misuse.
Registered Pharmacist (R.Ph.) means a pharmacist who, pursuant to the provisions of M.G.L. c. 112, § 24, is licensedregistered 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.
Serious adverse drug event means any untoward, preventable medical occurrence associated with the use of a drug in humans that results in any of the following outcomes:
(a)death;
(b)a life-threatening outcome;
(c)inpatient hospitalization or prolongation of existing hospitalization;
(d)a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
(e)a congenital anomaly or birth defect; or
(f)any other kind of harm as determined by the Department of Public Health in regulation.
Adverse medical occurrences directly associated with the use of a drug in humans that may not immediately result in one of the outcomes listed in 247 CMR 20.01(1)(b) may be considered a serious adverse drug event if they develop into or result in any of the outcomes listed in 247 CMR 20.01(1)(b).
Serious disability means injuries requiring major intervention and loss, or substantial limitation of bodily function lasting greater than seven days (e.g. bodily function related to breathing, dressing/undressing; drinking; eating; eliminating waste products; getting into and out of bed, chair, etc.; hearing; seeing; sitting; sleeping or walking).
Serious injury means an injury that is life threatening, results in serious disability or death, or results in additional treatment, testing, or monitoring in a hospital or emergency department.
State agency means any U.S. State or Territory that licenses, oversees, or otherwise regulates pharmacies or pharmacist practice.
Supervising physician means a physician who:
(a)holds an active license in good standing to practice medicine in the Commonwealth of Massachusetts; and
(b)may delegate specific CDTM services to an authorized pharmacist pursuant to the terms of the CDTM agreement with the authorized pharmacist.
Transfer of Ownership means a transfer of a majority interest in the ownership of the pharmacy. In the case of a corporation, transfer of ownership includes the transfer of a majority of the stock thereof. In the case of a partnership, transfer of ownership includes the transfer of a majority of the partnership interest. In the case of a trust, transfer of ownership includes change of the trustee, or majority of trustees. In the case of a non-profit corporation, such changes in the corporate membership or directors as the Board determines to constitute a shift of 5% or more in control of the pharmacy.
UniversalClaimForm(UCF)meansanationallyrecognizedstandardformdevelopedbythe NCPDPusedforbillingprescriptiondrugclaimstoinsuranceplans.UniversalClaimFormsare availablethrough a pharmacy's local wholesaler.
WholesaleDistributionmeansdistributionofprescriptiondrugsandprescriptiondevicesto persons otherthan a consumer or patient, but does not include:
(a)Intracompanysales;
(b)thepurchaseorotheracquisitionbyahospitalorotherhealthcareentitythatisa memberofagrouppurchasingorganizationofadrugordeviceforitsownusefromthe grouppurchasingorganizationorfromotherhospitalsorhealthcareentitiesthataremembers ofsuchorganizations;
(c)thesale,purchaseortradeofadrugordeviceoranoffertosell,purchaseortradeadrug byacharitableorganizationdescribedinsection501(c)(3)oftheInternalRevenueCodeof 1954 to a nonprofit affiliate of the organization to the extent otherwise permitted bylaw;
(d)thesale,purchaseortradeofadrugordeviceoranoffertosell,purchaseortradeadrug ordeviceamonghospitalsorotherhealthcareentitiesthatareunder commoncontrol;for purposesof247CMR7.00,"commoncontrol"meansthatpowertodirectorcausethe directionofthemanagementandpoliciesofapersonoranorganization,whetherby ownership of stock, voting rights, bycontract or otherwise;
(e)thesale,purchase ortradeofadrugordeviceoranoffertosell,purchase,ortradea drugordeviceforemergencymedicalreasons;forpurposesof247CMR7.00,"emergency medicalreasons"includestransfersofprescriptiondrugsordevicesbyaretailpharmacyto anotherretail pharmacyto alleviate atemporaryshortage;
(f)thesale,purchaseortradeofadrugordevice,anoffertosell,purchaseortradeadrug or device, or thedispensing ofa drugor device pursuant to a prescription;
(g)thelawfuldistributionofdrugsamplesbymanufacturers'representativesordistributors' representatives; or
(h)the sale, purchase ortradeof blood and blood components intended for transfusion.
WholesaleDistributormeans aperson engaged in wholesaledistributionofprescription drugs ordevicesincluding,butnotlimitedto,manufacturers;repackers;own-labeldistributors; private-labeldistributors;jobbers;brokers;warehouses,includingmanufacturers'and distributors'warehouses,chaindrugwarehouses,andwholesaledrugwarehouses;independent wholesaledrugtraders;andretailpharmacies thatconductwholesaledistributions.
2.03:Severability
The provisions of 247 CMR et. seq. are severable. If any provision therein is declared unconstitutional or invalid by a court of competent jurisdiction, the validity of the remaining portions shall not be affected.
REGULATORY AUTHORITY
247 CMR 2.00: M.G.L. c. 112, §§ 24 and 42A
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