Medical Marijuana Dispensary Permit Application · Medical Marijuana Dispensary Permit Application...

1UpdatedFebruary1,2017–SeeGuidance

Medical Marijuana Dispensary Permit Application

Youmayapplyforonedispensarypermitinthisapplicationforanyofthemedicalmarijuanaregionslistedbelow.Aseparateapplicationmustbesubmittedforeachprimarydispensarylocationsoughtbytheapplicant.PleaseseetheMedicalMarijuanaOrganizationPermitApplicationInstructionsforatableofthecountieswithineachmedicalmarijuanaregionandthecountiesinwhichyouareeligibletolocateyourprimarydispensary.

Pleasechecktoindicatethemedicalmarijuanaregion,andspecifythecounty,forwhichyouareapplyingforadispensarypermit:

☐ Northwest ☐ Northcentral ☐ Northeast☐ Southwest ☐ Southcentral ☐ Southeast

County1(PrimaryDispensaryLocation):MontgomeryCounty2(ifapplicable): County3(ifapplicable):

Department of Health Use Only

# Received

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PennsylvaniaDepartmentofHealthMedicalMarijuanaDispensaryPermitApplication

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FacilityName:BlackLabRx-ColmarAddress:252BethlehemPike,SuiteA1City:Colmar State:PA ZipCode:18915County:Montgomery Municipality:HatfieldTownshipPLEASEPROVIDEADESCRIPTIONOFTHEPUBLICACCESSTOTHEDISPENSARYLOCATION,INCLUDINGANYLOCALPUBLICTRANSPORTATIONTHATMAYBEAVAILABLE:

BlackLabBotanicals,LLCd/b/aBlackLabRxhasplannedadispensarylocatedat252BethlehemPikeinColmar,PA.Therearemultiplemethodsofapproachtothislocation,whicharedetailedbelow.Thisisaconvenientlocationforpatientstoaccessfromanyofthemajorsurroundinginterstates.BlackLab’smanagementteamcarefullychosealocation,takingintoconsiderationpatientsafetyandaccessibility.Thislocationalsoallowsforconvenientparkingforcustomerswhodriveoraredriventothedispensarybycaretakers.InterstateApproachesbyCarorPublicTransport:Ifyouareapproachingfromthesouth,ourfacilityislocatedabout25minutesdrivingtimeNorthofI-276onRT309.Ifyouareapproachingfromthewest,ourfacilityisabout20minutesdrivingtimebytakingPA-63EtowardsDerstineRdandBergeyRdtoPA-309SinHatfieldTownship.Ifyouareapproachingfromthenorth,wearedirectlysouthonPA-309S,approximately20minutesdrivingtimefromQuakertown,PA.ThisrunsparalleltoI476Saswellifyouarefurthernorth.TrainlinesandSEPTA:ColmarstationisaSEPTARegionalRailStationinColmar,Pennsylvania.LocatedatBethlehemPikeandWalnutStreet,itservestheLansdale/DoylestownLineTheColmarStationisashort12-minutewalktothesite.


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PARKINGThereisaparkinglostassociatedwiththebuildingandcanbeusedforpatientparking.

SecondDispensaryLocationFacilityName: Address: City: State:PA ZipCode: County: Municipality: PLEASEPROVIDEADESCRIPTIONOFTHEPUBLICACCESSTOTHEDISPENSARYLOCATION,INCLUDINGANYLOCALPUBLICTRANSPORTATIONTHATMAYBEAVAILABLE:

Pleaselimityourresponsetonomorethan5,000words.

ThirdDispensaryLocationFacilityName: Address: City: State:PA ZipCode: County: Municipality: PLEASEPROVIDEADESCRIPTIONOFTHEPUBLICACCESSTOTHEDISPENSARYLOCATION,INCLUDINGANYLOCALPUBLICTRANSPORTATIONTHATMAYBEAVAILABLE:

Pleaselimityourresponsetonomorethan5,000words.

Part B – Diversity Plan (Scoring Method: 100 Points) INACCORDANCEWITHSECTION615OFTHEACT(35P.S.§10231.615),ANAPPLICANTSHALLINCLUDEWITHITS

APPLICATIONADIVERSITYPLANTHATPROMOTESANDENSURESTHEINVOLVEMENTOFDIVERSEPARTICIPANTSANDDIVERSE

GROUPSINOWNERSHIP,MANAGEMENT,EMPLOYMENT,ANDCONTRACTINGOPPORTUNITIES.DIVERSEPARTICIPANTSINCLUDEAPERSON,INCLUDINGANATURALPERSON;INDIVIDUALSFROMDIVERSERACIAL,ETHNICANDCULTURALBACKGROUNDSANDCOMMUNITIES;WOMEN;VETERANS;INDIVIDUALSWITHDISABILITIES;CORPORATION;PARTNERSHIP;ASSOCIATION;TRUSTOROTHERENTITY;ORANYCOMBINATIONTHEREOF,WHOARESEEKINGAPERMITISSUEDBYTHE

DEPARTMENTOFHEALTHTOGROWANDPROCESSORDISPENSEMEDICALMARIJUANA.DIVERSEGROUPSINCLUDETHEFOLLOWINGBUSINESSESTHATHAVEBEENCERTIFIEDBYATHIRD-PARTYCERTIFYINGORGANIZATION:ADISADVANTAGEDBUSINESS,MINORITY-OWNEDBUSINESS,ANDWOMEN-OWNEDBUSINESSASTHOSETERMSAREDEFINEDIN74PA.C.S.§303(B);ANDASERVICE-DISABLEDVETERAN-OWNEDSMALLBUSINESSORVETERAN-OWNEDSMALLBUSINESSASTHOSE

TERMSAREDEFINEDIN51PA.C.S.§9601.


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Section 3 – Diversity Plan Bychecking“Yes,”theapplicantaffirmsthatithasadiversityplanthatestablishesagoalofopportunityandaccessinemploymentandcontractingbythemedicalmarijuanaorganization.Theapplicantalsoaffirmsthatitwillmakeagoodfaithefforttomeetthediversitygoalsoutlinedinthediversityplan.ChangestothediversityplanmustbeapprovedbytheDepartmentofHealthinwriting.

TheapplicantfurtheragreestoreportparticipationlevelandinvolvementofDiverseParticipantsandDiverseGroupsintheformandfrequencyrequiredbytheDepartment,andtoprovideanyotherinformationtheDepartmentdeemsappropriateregardingownership,management,employment,andcontractingopportunitiesbyDiverseParticipantsandDiverseGroups.

Yes No

DIVERSITYPLAN

INNARRATIVEFORMBELOW,DESCRIBEAPLANTHATESTABLISHESAGOALOFDIVERSITYINOWNERSHIP,MANAGEMENT,EMPLOYMENTANDCONTRACTINGTOENSURETHATDIVERSEPARTICIPANTSANDDIVERSEGROUPSAREACCORDEDEQUALITY

OFOPPORTUNITY.TOTHEEXTENTAVAILABLE,INCLUDETHEFOLLOWING:

1. ThediversitystatusofthePrincipals,Operators,FinancialBackers,andEmployeesoftheMedicalMarijuanaOrganization.

2. AnofficialaffirmativeactionplanfortheMedicalMarijuanaOrganization.3. InternaldiversitygoalsadoptedbytheMedicalMarijuanaOrganization.4. Aplanfordiversity-orientedoutreachoreventstheMedicalMarijuanaOrganizationwill

conductduringthetermofthepermit.5. Contractswithdiversegroupsandtheexpectedpercentageanddollaramountofrevenuesthat

willbepaidtothediversegroups.6. AnymaterialsfromtheMedicalMarijuanaOrganization’smentoring,training,orprofessional

developmentprogramsfordiversegroups.7. AnyotherinformationthatdemonstratestheMedicalMarijuanaOrganization’scommitmentto

diversitypractices.8. Aworkforceutilizationreportincludingthefollowinginformationforeachjobcategorywithin

theMedicalMarijuanaOrganization:a. Thetotalnumberofpersonsemployedineachjobcategory,b. Thetotalnumberofmenemployedineachjobcategory,c. Thetotalnumberofwomenemployedineachjobcategory,d. Thetotalnumberofveteransineachjobcategory,e. Thetotalnumberofservice-disabledveteransineachjobcategory,andf. Thetotalnumberofmembersofeachracialminorityemployedineachjobcategory.

9. Anarrativedescriptionofyourabilitytorecordandreportonthecomponentsofthediversityplan.

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BlackLabBotanicalsOfficialDiversity/AffirmativeActionPlanIntroduction

AlongwithPennsylvania’slegislativeandexecutiveleadership,BlackLabBotanicals(BLB)recognizesmedicalmarijuana’spotentialtoaddresshumandiseasestatesthroughthedevelopmentofpharmaceuticalproducts.BLBalsorecognizesthesocietalgoalsthatcanbeachievedbygoodcorporatecitizenscommittedtoengaging,developing,andsustainingaworkforceinclusiveoftheraciallyandethnicallydiversepopulationofsoutheasternPennsylvania.BLB’sfoundingmembersareconfidentintheirabilitytoworkwithexisting,federallyestablishedmethodologiestoestablishaneffectiveworkforcethatreflectsthepopulationcharacteristicsofitsoperatingarea.

InternalDiversityGoalinthePharmaceuticalContext

Inthecontextofcommitments(i)toproducingpharmaceuticalproductsinamannerconsistentwiththeproductionstandardsotherwiseapplicableinAmerica,and(ii)toprovidingapositiveworkingenvironmentwithindustry-leadingcompensation,medicalandotherbenefits,401(k),andinternaldevelopmentandexternaltrainingopportunities,BLBisalsocommittedtooperatingwithaworkforcethatmatchesthediversityofthepopulationofsoutheasternPennsylvania.Inthespiritofsimultaneouslyadvancingeachofthesegoals,BLBoffersitsDiversity/AffirmativeActionPlan.

Asamatterofbasicinformation,basedonU.S.Censusdata,BLBunderstandstheAfrican-Americanpopulationinitsareatoconstituteapproximately37percentofthetotalpopulation,theCaucasianpopulationapproximately56percent,andtheAsianpopulationapproximately7percent.TheHispanicpopulation,whichtheCensusdeclarescanbefoundamongtheotherraces,constitutesapproximately15percentofthetotalpopulation,andisincludedwithintheotherracialcategories.BLB’sofficialandinternaldiversitygoalistomatchitsworkforcetothesepopulationcharacteristics.

DiversityPlanMethodology

BLB’sworkforceengagement,development,andsustainabilityplanembracestheopportunitytocreateamedicalmarijuanaGrower/Processorcapableofdevelopingarawmaterialwhosepharmaceuticalactivityhasbeenunderdevelopedforatleast50years.OurplanbeginswithcommunityengagementthroughsoutheasternPennsylvania’snumerouscollegesanduniversities.BLBhasestablishedcontactwiththeplacementofficesandthesciencedepartmentsofseveraloftheseinstitutions,includingTemple,Drexel,andStJoseph’s,toidentifyemployeesandresearchpartners.

BLB’sDiversity/AffirmativeActionPlanreflectstheapproachofthefederalaffirmativeactionguidelinesdescribedin41CFR60,includingcommunityoutreachandrecordkeeping.BecauseBLBwillbeaverysmallorganizationduringitsstart-upphase,eachadditionalemployeewill,necessarily,haveasignificantimpactonitspercentageracialcomposition.


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5. KeepingBLB’sOperationsDirectorinformedofequalopportunityprogressandreportingpotentialproblemareaswithinthecompanythroughquarterlyreports;

6. ReviewingBLB’sEEO/AAPforqualifiedminoritiesandwomenwithallmanagersandsupervisorsatalllevelstoensurethatthepolicyisunderstoodandisfollowedinallpersonnelactivities;

7. Auditingthecontentsofthecompany’sbulletinboardtoensurecomplianceinformationispostedandup-to-date;and

8. ServingasliaisonbetweenBLBandregulatoryagencies.

ResponsibilitiesofManagersandSupervisors:

ItistheresponsibilityofallmanagerialandsupervisorystafftoimplementBLB’sAAP.Theseresponsibilitiesinclude,butarenotlimitedto:

1. Assistingintheidentificationofproblemareas,formulatingsolutions,andestablishingdepartmentalgoalsandobjectiveswhennecessary;

2. Reviewingthequalificationsofallapplicantsandemployeestoensurequalifiedindividualsaretreatedinanondiscriminatorymannerwhenhiring,promotion,transfer,andterminationactionsoccur;and

3. Reviewingthejobperformanceofeachemployeetoassesswhetherpersonnelactionsarejustifiedbasedontheemployee’sperformanceofhisorherduties

ExampleofCorrectiveandPreventiveActionReportIdentificationofProblemAreasAreasofConcern CorrectiveActions•Underutilizationofminoritiesandwomenin[jobclassification]whereexternal-hiringopportunitiesoccurred.Concernregardinglowminorityandfemaleapplicantflowrateresultingfrominadequaterecruitmentforbothjobgroups.

•Nolaterthan[datewithin90days],notifymanagementandprofessionalrecruitmentsources,inwriting,ofBLB’sinterestinattractingqualifiedminoritiesandwomentoapplyforjobopenings.•NolaterthanMarch1,2018,expandBLB’srecruitmentprogramtocollegesanduniversitieswithsignificantpercentagesofminorityandfemalestudents.

•Underutilizationofwomenin[jobclassification]entry-levelblue-collarjobs.Concernregardinglowfemaleapplicantflowrateresultingfrominadequaterecruitment.

•Nolaterthan[datewithin90days],contactthelocalYWCAandsimilarcommunityorganizations,localvocationalschool,andtrainingcenterstoinformthemofBLB’sinterestinattracting


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qualifiedfemaleapplicants.

•Highterminationrateforfemalesin[jobclassification].

•Immediatelyreviewexitinterviewsurveyofterminatedfemalestoconfirmvoluntaryreasonforleaving

BlackLabBotanicalsAction-OrientedPrograms

BLBhasinstitutedactionprogramstoeliminateidentifiedproblemareasandtohelpachievespecificaffirmativeactiongoals.Theseprogramsinclude:

1. Conductingannualanalysesofjobdescriptionstoensuretheyaccuratelyreflectjobfunctions;

2. Reviewingjobdescriptionsbydepartmentandjobtitleusingjobperformancecriteria;

3. Makingjobdescriptionsavailabletorecruitingsourcesandavailabletoallmembersofmanagementinvolvedintherecruiting,screening,selectionandpromotionprocesses;

4. Evaluatingthetotalselectionprocesstoensurefreedomfrombiasthrough:

a. Reviewingjobapplicationsandotherpre-employmentformstoensureinformationrequestedisjob-related;

b. Evaluatingselectionmethodsthatmayhaveadisparateimpacttoensurethattheyarejob-relatedandconsistentwithbusinessnecessity;

c. Trainingpersonnelandmanagementstaffonproperinterviewtechniques;and

d. TraininginEEOformanagementandsupervisorystaff;

5. Usingtechniquestoimproverecruitmentandincreasetheflowofminorityandfemaleapplicants.BLBcurrentlyundertakesthefollowingactions:

a. Includesthephrase"EqualOpportunity/AffirmativeActionEmployer"inallprintedemploymentadvertisements;

b. Placeshelpwantedadvertisement,whenappropriate,inlocalminoritynewsmediaandwomen'sinterestmedia;

c. Disseminatesinformationonjobopportunitiestoorganizationsrepresentingminorities,womenandemploymentdevelopmentagencieswhenjobopportunitiesoccur;

d. Encouragesallemployeestoreferqualifiedapplicants;

e. Activelyrecruitsatsecondaryschools,juniorcolleges,collegesanduniversitieswithsignificantminorityorfemaleenrollments;andrequestsemploymentagenciestoreferqualifiedminoritiesandwomen;


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6. Performingaself-auditofitscompensationpractices;and

7. Ensuringthatallemployeesaregivenequalopportunityforpromotion.Thisisachievedby:

a. Postingpromotionalopportunities;

b. Offeringcounselingtoassistemployeesinidentifyingpromotionalopportunities,trainingandeducationalprogramstoenhancepromotionsandopportunitiesforjobrotationortransfer;and

c. Evaluatingjobrequirementsforpromotion

InternalAuditandReportingSystem

TheFinanceandAdministrationManagerhastheresponsibilityfordevelopingandpreparingtheformaldocumentsoftheEEO/AAP.TheFinanceandAdministrationManagerisresponsiblefortheeffectiveimplementationoftheEEO/AAP;however,responsibilityislikewisevestedwitheachdepartmentmanagerandsupervisor.BLB’sauditandreportingsystemisdesignedto:

• MeasuretheeffectivenessoftheEEO/AAPprogram;

• Documentpersonnelactivities;

• Identifyproblemareaswhereremedialactionisneeded;and

• DeterminethedegreetowhichBLB’sEEO/AAPgoalsandobjectiveshavebeenobtained.

Thefollowingpersonnelactivitiesarereviewedtoensurenondiscriminationandequalemploymentopportunityforallindividualswithoutregardtotheirrace,color,sex,religion,ornationalorigin:

• Recruitment,advertising,andjobapplicationprocedures;

• Hiring,promotion,upgrading,awardoftenure,layoff,recallfromlayoff;

• Ratesofpayandanyotherformsofcompensationincludingfringebenefits;

• Jobassignments,jobclassifications,jobdescriptions,andsenioritylists;

• Sickleave,leavesorabsence,oranyotherleave;

• Training,apprenticeships,attendanceatprofessionalmeetingsandconferences;and

• Anyotherterm,condition,orprivilegeofemployment.

ThefollowingdocumentsaremaintainedasacomponentofBLB’sinternalauditprocess:

1. Anapplicantflowlogshowingthename,race,sex,dateofapplication,jobtitle,interviewstatusandtheactiontakenforallindividualsapplyingforjobopportunities;


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2. Summarydataofexternaljoboffersandhires,promotions,resignations,terminations,andlayoffsbyjobgroupandbysexandminoritygroupidentification;

3. Summarydataofapplicantflowbyidentifying,atleast,totalapplicants,totalminorityapplicants,andtotalfemaleapplicantsforeachposition;

4. Maintenanceofemploymentapplications(nottoexceedoneyear);and

5. RecordspertainingtoBLB’scompensationsystem.

BLB’sauditsystemincludesaquarterlyreportdocumentingBLB’seffortstoachieveitsEEO/AAPresponsibilities.ManagersandsupervisorsareaskedtoreportanycurrentorforeseeableEEO/AAPproblemareasandareaskedtooutlinetheirsuggestions/recommendationsforsolutions.Ifproblemareasarise,themanagerorsupervisoristoreportproblemareasimmediatelytotheFinanceandAdministrationManager.Duringquarterlyreporting,thefollowingoccurs:

1. TheFinanceandAdministrationManagerwilldiscussanyproblemsrelatingtosignificantrejectionratios,EEO/AAPcharges,etc.,withtheOperationsDirector;and

2. TheFinanceandAdministrationManagerwillreportthestatusoftheBLBsEEO/AAPgoalsandobjectivestotheOperationsDirector.TheFinanceandAdministrationManagerwillrecommendremedialactionsfortheeffectiveimplementationoftheEEO/AAP.

BlackLabBotanicalsEqualOpportunity/AffirmativeActionPlan

GuidelinesonDiscriminationBecauseofReligionorNationalOrigin

ItisthepolicyofBLBtotakeaffirmativeactiontoensurethatapplicantsareemployed,withoutregardtotheirrace,color,sex,religionornationalorigin.Suchactionincludes,butisnotlimitedtothefollowingemploymentpractices:hiring,promotion,demotion,transfer,recruitmentorrecruitmentadvertising,layoff,termination,ratesofpayorotherformsofcompensationandselectionfortraining.

Employmentpracticeshavebeenreviewedtodeterminewhetherfemalesandmales,andmembersofthevariousracial,religiousand/orethnicgroupsarereceivingfairconsiderationforjobopportunities.Attentionhasbeendirectedtowardexecutiveandmiddlemanagementlevels.

1. ThepolicyconcerningBLB’sobligationtoprovideequalemploymentopportunitywithoutregardtorace,color,sex,religionornationaloriginiscommunicatedtoallemployeesviaemployeehandbooks,policystatementandtheEqualOpportunity/AffirmativeActionProgram.

2. InternalprocedureshavebeendevelopedinthisprogramtoensurethatBLB’s


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7.

8.

B. PLEASEDESCRIBETHEEMPLOYEEQUALIFICATIONSOFEACHPRINCIPALANDEMPLOYEE.

1. Pleaserefertothedocucumenttitled:

2. BlackLabBotanicalsLLC_03202017_Dispensary_EMPLOYEEQUALIFICATIONS,DESCRIPTIONOFDUTIESANDTRAINING(CONTD.)

3.

4.

5.

6.

7.

8.

C. PLEASEDESCRIBETHESTEPSTHEAPPLICANTWILLTAKETOASSURETHATEACHPRINCIPALANDEMPLOYEEWILLMEETTHETWO-HOURTRAININGREQUIREMENTUNDERTHEACTANDREGULATIONS.

1. Pleaserefertothedocucumenttitled:

2. BlackLabBotanicalsLLC_03202017_Dispensary_EMPLOYEEQUALIFICATIONS,DESCRIPTIONOFDUTIESANDTRAINING(CONTD.)

3.

4.

5.

6.

7.

8.


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DOH REDACTED


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DOH REDACTED


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PLEASEPROVIDEANEXPLANATIONOFANYRESPONSESABOVETHATWEREANSWEREDASA“NO”ANDHOWYOUWILLMEET

THESEREQUIREMENTSBYTHETIMETHEDEPARTMENTDETERMINESYOUTOBEOPERATIONALUNDERTHEACTANDREGULATIONS:

N/A

B. PLEASEDESCRIBEYOURPLANSREGARDINGTHESTORAGEOFMEDICALMARIJUANAANDMEDICALMARIJUANA

PRODUCTSWITHINYOURFACILITY:

DOH REDACTED


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DOH REDACTED


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DOH REDACTED


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DOH REDACTED


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DOH REDACTED


2

DOH REDACTED


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PLEASEPROVIDEANEXPLANATIONOFANYRESPONSESABOVETHATWEREANSWEREDASA“NO”ANDHOWYOUWILLMEET

THESEREQUIREMENTSBYTHETIMETHEDEPARTMENTDETERMINESYOUTOBEOPERATIONALUNDERTHEACTANDREGULATIONS:

N/A

C. PLEASEDESCRIBEYOURAPPROACHREGARDINGTHEIMPLEMENTATIONOFANINVENTORYMANAGEMENTPROCESS.THISAPPROACHMUSTALSOINCLUDEAPROCESSTHATPROVIDESFORTHERECALLOFMEDICALMARIJUANAPRODUCTS

ANDTHEMANAGEMENTOFMEDICALMARIJUANAPRODUCTRETURNSFROMYOUTOTHEORIGINATING

GROWER/PROCESSOR:

DOH REDACTED


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Section 16 – Sanitation and Safety

A. PLEASEPROVIDEASUMMARYOFTHEINTENDEDSANITATIONANDSAFETYMEASURESTOBEIMPLEMENTEDATEACH

PROPOSEDFACILITYLISTEDINTHEPERMITAPPLICATION.THESEMEASURESSHOULDCOVER,BUTARENOTBELIMITED

TO,THEFOLLOWING:AWRITTENPROCESSFORCONTAMINATIONPREVENTION,PESTPROTECTIONPROCEDURES,MEDICALMARIJUANAPRODUCTHANDLERRESTRICTIONS,ANDHAND-WASHINGFACILITIES.

Section16–SanitationandSafety

RegulatoryReferences

• §1161.34SanitationandSafety

• §27.153Restrictionsonfoodhandlers.

StandardOperatingProcedures

• SanitationPractices

• SafetyPractices

• EmployeeHandbook

• RightsandResponsibilitiesHandbookforPatients

ResponsiblePersonnel

• SecurityManager

• DispensaryManager

3rdPartyCertificationforPost-LicenseEngagement

• PatientFocusedCertification(non-profitbasedtraining,education,andcertification)

Overview

TheSecurityandDispensaryManagerareresponsiblefortheimplementationofpoliciesandprocedurestoprotectallpersonnelinalloperations.TheMedicalDirectorandSeniorBLBManagers(“SeniorManagement”)willprovideallBLBemployeeswithadequatesafetytrainingtocomplywithstandardoperations.SeniorManagementwillconsistentlyensurealldepartmentspecificsafetyprotocolsaredevelopedandmaintainedtoensureasafeworkingenvironment.PatientFocusedCertification(PFC)willbeutilizedforregulatoryinspectionpreparedness,andassessmentofallSOPs,policies,andprocedures

TheBLBDispensaryfacilitywillmaintainsanitaryconditionstoreducethepotentialforcontaminationoradulterationofthemedicalmarijuanaproductsstoredwithinthefacility.Thefollowingpoliciesand


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procedureswillapply:

• Wastewillbepropertyremovedandplacedintoexteriorreceptaclesforarefuseservicetopickup.

• Theconditionofthefacilitywillbekeptingoodrepair.Walls,floors,andceilingswillbecleanandingoodfunctioningorder.

• Practicestopreventpestswillbeestablishedthroughanintegratedpestmanagementsystem.Techniquestodeterandmanagethepresenceofpestswillbemaintainedinsideaswellasexternalareasofthebuilding.

• Allcleaningchemicalsorsanitizingagentswillbeclearlymarked/labeledandstoredoutofreachofunauthorizedpersons.

• Employeesindirectcontactwithmedicalmarijuanaproductsshalladheretofoodhandlingguidelinesasseenin§27.153.

• Signswillbepostedinstructingallemployeestowashhandsbeforereturningtowork

• Sufficienthandwashingstationswillbeprovidedtobothemployeesandpatients.

• Adequateandeasilyaccessiblelavatorieswillbeprovidedtoemployeeswhichwillbekeptinsanitaryconditionandgoodworkingorder.

• BLBDispensarywillcomplywithallstateandlocalbuildingcoderequirements.

EmployeeSanitation:

Employeesthatworkindirectcontactwithmedicalmarijuanaaresubjecttotherestrictionsoffoodhandlers(section27.153,relatingtorestrictionsoffoodhandlers).Employeesshallconformtosanitarypracticesasfollows:

• Maintainadequatepersonalhygiene.

• Washhandsthoroughlybeforestartingworkandanyothertimehandshavebecomesoiledorcontaminated,andalltimespriortodispensingmedicalmarijuanatoapatientorcaregiver.

• Anyworkerdiagnosedwith,orsuspectedofhavinganyofthefollowingdiseasesisprohibitedforhandlingmarijuanaproducts;Amebiasis,EnterohemorrhagicE.coli,Shigellosis,Typhoidfeverorparatyphoidfever, HepatitisA,viralhepatitis,orjaundiceofunspecifiedetiology,orPersistentdiarrhea

SAFETY

Incompliancewithfederallaw,allemployeesareentitledtoasafeworkplace.BLBwillprovideaworkplacefreeofknownhealthandsafetyhazards.Employeeswillbeinformedandhavetherighttospeakupaboutthemwithoutfearofretaliation.Employeeswillhave:

• AnnualOSHA-relatedtrainingfor;

A. PersonalProtectiveEquipment-TheOccupationalSafety&HealthAdministration(OSHA)requiresemployerstoevaluateallworkareastodeterminewhetherhazardsarepresent,orarelikelytobepresent,whichnecessitatetheuseofpersonalprotectiveequipment(PPE).TheJobSafetyAssessmentFormhasbeendesignedto


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aidintheselectionofappropriatePPEinworkareaswhereknownorpotentialhazardsexist.

§ BLBwillutilizeaJobSafetyAssessmenttoaidintheselectionofappropriatePPEinworkareaswhereknownorpotentialhazardsexist.

• Lockout/Tagout-AsrequiredbytheOSHAStandard29CFR1910.147,TheControlofHazardousEnergySources(Lockout/Tagout),thispolicycontainsthenecessaryelementsofanenergycontrolprogram,whichincludesdocumentedLockout/Tagoutprocedures,employeetraining,periodicinspectionsandthemeanstoenforcecompliance.

• Chemicalhazardsintheworkplace,asrequiredbytheOSHAHazardCommunicationStandard(29CFR1910.1200).

§ ItistheresponsibilityofthereceivingagenttoassurethatnochemicalsarereceivedintothebuildingwithoutaMaterialSafetyDataSheet/SafetyDataSheet(MSDS/SDS)onfile.

• FireEvacuation/EmergencyEvacuationPolicy

• BLBwillpostForm300logsincompliancewithOSHA’sFormsforRecordingWork-RelatedInjuriesandIllnesses

• Safetyprotocolsforjobhazardanalysismustincludeataminimum:

1. Employeeaccidentreportingandinvestigationpolicies,

2. Firepreventionandresponseplans,

3. Materialshandlingandhazardcommunicationspolicies,and

4. Personalprotectiveequipmentpolicies.

FirstAid

Theoperationwillbeequippedwitheasilyaccessiblefirstaidkits.Eachkitiseasilyaccessiblewithintheworkareas.EachkitischeckedmonthlybytheDirectorordesigneetoensurethatitisfullyequippedandthatallitemsintheboxarewithinthedateofexpiration.

WorkplaceIncidentReportingandInvestigation:BLBmaintainsrecordsofallaccidents,whetherminorormajor.AnIncidentReportFormisfilledoutforanincidenceoraccident,andsubmitedittotheappropriatedepartment.FormsarereviewedbytheDirectorandaction(ifany)willbetaken.IncidentReportingFormscanalsobeusedtoreportanyunsafepracticesobservedbyemployees.

MaterialStorage

Theoperationmayutilizesomechemicals(i.e.,cleaningagents)on-sitethatareconsideredhazardous.Toxiccleaningcompounds,sanitizingagentsandsolventsmustbelabeledandstoredinsuchawaythatpreventscontaminationofmedicalmarijuanaandinamannerthatcomplieswithapplicablelawsandregulations.Flammableliquids(i.e.,rubbingalcohol)arestoredinaflammablesolventcabinet.TheSafetyDataSheet(SDS)foreachchemicalisavailableelectronicallyinthedocumentmanagementsystemandshouldbereadandunderstoodbeforeusinganychemical.


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FireSafety

Employeesandvisitorswillrequiredtobefamiliarwiththelocationofallemergencyexits.Employeetrainingwillincludefamiliarizingthemwiththeoperationoffireextinguishers.

Employeesshouldlearnthepotentialfirehazardsintheirarea.FireextinguishersareratedasA,B,C,orD(orcombinationsthereof)foruseagainstthedifferentclassesoffires.Employeeswillbetrainedontheirrolesandresponsibilitiesduringafireandwillfamiliarizethemselveswiththeratingsoftheextinguisherslocatedinthevariousareassothattheymayknowwhattypesoffirescanbeextinguishedwiththem.Additionalfiresafetypoliciesinclude:

• Attempttofightsmallfiresonly,andonlyifthereisanescaperoutebehindyou.

• Extinguishersshouldbeinspectedmonthly.Itshouldbeensuredthat:

o Theextinguisherisnotblockedbyequipment,coats,orotherobjectsthatcouldinterferewithaccessinanemergency.

o Thepressureisattherecommendedlevel.

o Thenozzleorotherpartsarenotobstructed.

o Thepinandtamperseal(ifpresent)isintact.

o Therearenodents,leaks,rust,chemicaldepositsandothersignsofabuse/wear.Wipeoffanycorrosivechemicals,oil,gunk,etc.thatmayhavelandedontheextinguisher.

Fireextinguishersshouldbepressuretestedafter5yearstoensurethatthecylinderissafetouse.Iftheextinguisherisdamagedorneedsrecharginggetitreplacedimmediately.Iftheextinguisherisuseditshouldberechargedimmediately,regardlessofhowmuchwasused.

Evacuations:Intheeventthatthealarmissounded,followpostedevacuationroutesestablishedforeacharea.Donotuseelevators.Onceoutsidethebuildingmoveawayfromthedoortoallowotherstoexit,andheadthedesignatedarea.

Labeling&Packaging:Inadherenceto1161.28,Medicalmarijuanaproductsmustonlybeidentifiedbythenameofthegrower/processor,thenameofthedispensary,theformandspeciesofmedicalmarijuana,thepercentageofTHCandCBDcontainedinthemedicalmarijuanaproduct,andanyotherlabelingrequiredbytheDepartment.Theproductswillonlybedispensedtoapatientorcaregiverinasealedandproperlylabeledpackage.

BLBDirectorswillensurethatthelabelofthefinishedproduct:

• Containsawarningthatunauthorizeduseisunlawfulandwillsubjectthepurchaserorusertocriminalpenalties.

• Containsthefollowingwarningstating:Thisproductisformedicinaluseonly.Womenshouldnotconsumeduringpregnancyorwhilebreastfeedingexceptontheadviceofthepractitionerwhoissuedthecertificationand,inthecaseofbreastfeeding,theinfant'spediatrician.Thisproductmightimpairtheabilitytodriveoroperateheavymachinery.Keepoutofreachofchildren.

• Containsawarningthatthemedicalmarijuanamustbekeptintheoriginalcontainerinwhichitwasdispensed.


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• Iseasilyreadable.

• Isconspicuouslyplacedonthepackage.

• Includesthename,addressandpermitnumberofthegrower/processor.

• Liststhetype,quantityoftheproductandtheamountofindividualdosescontainedwithinthepackageandthespeciesandpercentageofTHCandCBD,andotherapplicableingreidents.

• Includesthenameandaddressofthedispensary,anexpirationandpackingdate,properstorageinstructions,andanyotherinformationrequiredbytheDepartment.

InaccordanceistheCommonwealthofPennsylvania’sguidelines,thelabelshallnotbearanyresemblanceto:

• Atrademarked,characteristicorproduct-specializedpackagingofanycommerciallyavailablefoodorbeverageproduct.

• Anystatement,artworkordesignthatcouldreasonablyleadanindividualtobelievethatthepackagecontainsanythingotherthanmedicalmarijuana.

• Anyseal,flag,crest,coatofarmsorotherinsigniathatcouldreasonablymisleadanindividualtobelievethattheproducthasbeenendorsed,manufacturedorapprovedforusebyanystate,countyormunicipalityoranyagencythereof.

• Anycartoon,colorscheme,image,graphicorfeaturethatmightmakethepackageattractivetochildren.

EmergencyActionPlan

1) AfullydetailedEmergencyActionPlanwillbemaintainedbytheSecurityManagerinalocationvisibletoallemployees.

i) AllemployeeswillhaveyearlytrainingontheEmergencyActionPlan.ii) Theplanwillincludephonenumbersandcontactnamesforutilitycontacts(electricity,

water,gas,oil),securitycompanycontacts,localfireandpolice,aswellasacalllistofSeniorManagerstobenotifiedintheeventofanemergency.

Section 17 – Recordkeeping

A. PLEASEPROVIDEASUMMARYOFYOURRECORDKEEPINGPLANATEACHPROPOSEDFACILITYLISTEDINTHEPERMITAPPLICATION.THISPLANSHOULDCOVER,BUTISNOTLIMITEDTO,RECORDSOFINVENTORYANDALLDISPENSINGTRANSACTIONS:


66

Section17–RecordKeepingRegulatoryReferences

• 21CFR111SubpartP§111.605and§111.610• §1161.39ElectronicTrackingSystem• 21CFR11ElectronicRecords:ElectronicSignatures

StandardOperatingProcedures• RecordRetention• GoodDocumentationPractices(ISO9000)

ResponsiblePersonnel• DispensaryManager• Pharmacists• PharmacyTechnicians• Receptionist• FinanceandAccountingPersonnel

RecordkeepingOverviewofPoliciesandproceduresTheoperationwill:

• Maintainrecordsofeachreceiptandtestingofmarijuanaproducts• Recordsincludethenameofthecultivation,processing,ormanufacturingoperationor

vendor• Recordsincludequantityandadescriptionofthemarijuanaproductofsufficientspecificity• Minimizedeliveriesattimesandinlocationswherecompliantindividualsarepresent• Theoperationwillinformallcultivation,processing,andmanufacturingoperationsandall

vendorsoftheestablishedpolicies• Allrecordsareavailableonrequesttotheregulatoryagencyandauthorizedindividualsin

compliancewithHIPPAandPersonalHealthInformationstandards.• Leadpharmacistmustauthorizereleaseofrecordstoany3rdparties

TheDispensaryManagerwillberesponsibleforsecurelymaintainingallrecords,logs,reports,inventories,andotherdocumentsinanauditableformatfornolessthanthreeyears.Electronicrecords:BlackLabBotanicalsshallmaintainallcompanyrecordsinanelectronicformat.Acloudbasedback-upsystemwillprovideasecondlocationforaduplicatecopyofallrecords.TheISO9000accrediteddocumentmanagementsystemistheprimarydatabaseforallinternalrecords.Recordsshallbemaintainedinthecompany’sinventorycontrolsystemandattachedtothebatchforwhichthereportwasissued.Recordswillbekeptasoriginalsandastruecopiesoraselectronicrecords.Allelectronicrecordswillcomplywithpart21CFR11ElectronicRecordsforelectronicsignaturesPaperrecords:Theoperationwillmaintainnotebooksandworksheets.Additionally,qualityassuranceemployeerecordsmaycontainpaperdocumentsincludingtrainingdocumentationforms.Allhumanresourcesrecordswillbemaintainedbyadministrativemanagementandsecurelystoredinaccordancewithallemploymentlaws.Allpaperrecordsrelatedtolaboratoryoperationsorpersonnelwillbescannedandmaintainedinthelaboratorymanagementsystem.Notebooksandlogswillbemaintainedinsecurefilingcabinetsaccessiblebyamanagerandanydesignees.Recordmaintenance:Inaccordancewithregulations,allelectroniccompanyrecordswillbe


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Section 19 Dispensary

BusinessHistoryandCapacitytoOperate

ThemembersofBlackLabBotanicalaresuccessfulprofessionalbusinessmenandwomenwithcombinedexperienceof100yearsinthemedical,construction,realestate,retail,andlegalindustries.AllarelifelongPennsylvaniaresidents.MembershaveseveralsuccessfulbusinessesalreadyinSoutheasternPAthatwillbearesourceofadministrative,accounting,andcompliancepersonnelforthisnewventure. ThecorecompetenciesofBlackLabBotanical’sprincipals,operators,andmanagementwillallowforsuccessful,compliant,andmutuallybeneficialoperationofafullyintegratedmedicalmarijuanaentity.Theexpertise,experience,andinvaluableinsightprovidedbyBLB’sorganizationwillallowforeasytransitionintotheindustry.Theoperators’skillsetswillbedetailedinaccordancewiththebusinessplan’sstartup,intermediate,andfulloperatingphases. Ateachstageofprogression,theBLBteamwillgrowinproportiontoitsbusinessneedsandeachteammemberbringsauniquesetofskills,guidance,andknowledge.BlackLabBotanicalsissubmittingapplicationstoreceiveapermittooperatetwomedicalcannabisdispensariesininRegion1.OurdispensarieswillretailhighqualitymedicinalcannabisproductsinfullcompliancewithallStateofPennsylvanialawsandregulationsassociatedwiththeCompassionateuseofthePAMedicalMarijuanaProgram.. Duringthestartupphaseofoperations,thefocusoftheorganizationwillbetobuildoutitsfacilities,installcertifiedequipment,andtrainacompetentstaffaboutthemarijuanaindustry.BLBisexcitedtoacceptandmastertheregulatorycompliancemandatedtorunapharmaceuticalcalibercompany.Theindirectexperienceandmanagementofheavilyregulatedindustrywillallowforeasytransitionintodirectingasuccessfuldispensary.Additionally,thesubstantiallevelofbusinessexpertiseandoutsiderelevantexperiencewillpositionBLBtodiligentlyfollowanddemonstratemasteryoftheexpectationsofregulatorystandardsestablishedbyboththestateandfederalregulations. ItisinternallyunderstoodbyourorganizationthatpatientsafetyandproductqualityisoftheutmostimportancetorunasuccessfuloperationinthePennsylvaniaMedicalMarijuanaProgram.Tomaintainthediligentstandardsandexpectationssetforthbythestate,BLBhasavarietyofindustries’expertisecontainedwithinuppermanagementtoshowadaptabilitytotheevolvingindustry.Wehavesurroundedourselveswiththebestintheindustry.

BlackLabBotanicalsWebsite:www.blacklabpa.com

BlackLabBotanicalsLLC_03202017_Dispensary_AttachmentH

FileContentSummary Page 1

BlackLabBotanicals,LLC–PA-100 Page 2-8

AnnmariePerlman,Principal Page 9

DavidH.Perlman,Principal Page 10

GeraldHamburg,Principal Page 11

MaryA.Magid,Principal Page 12

DavidS.Niggeman,Principal Page 13

BarryD.Gutin,Principal Page 14

LawrenceI.Cohen,Principal Page 15

GiacominaMassaro-Giordano,M.D.,Principal Page 16

PhilipA.Mandato,Jr.,M.D.,Principal Page 17

Date post:	07-Apr-2018
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