pharmacy license application packet · 2016. 9. 6. · when your application for a hospital...
TRANSCRIPT
DOH 690-300 September 2016
Hospital Pharmacy License Application Packet
Contents:1. 690-300 ..... Contents List/Mailing Information ..................................................1 page
2. 690-301 ..... Application Instructions Checklist ................................................2 pages
3. 690-302 ..... Hospital Pharmacy License Application .......................................3 pages
4. 690-249 ..... NPLEx Account Activation ...........................................................2 pages
5. 690-222 ..... NPLEx Exception Request ..........................................................2 pages
6. 631-020 ..... Prescription Monitoring Program CertificationofNoDispensingofControlledSubstances ............. 1 Page
7. RCW/WACandOnlineWebsiteLinks ...............................................................1 page
In order to process your request:
Mail your application with initial documentation and your check Send other documents not sent or money order payable to: with initial application to:
Department of Health Pharmacy Quality Assurance P.O.Box1099 CommissionCredentialing Olympia, WA 98507-1099 P.O. Box 47877 Olympia, WA 98504-7877
Contact us: 360-236-4700
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DOH 690-301 September 2016 Page 1 of 2
Application Instructions ChecklistWhenyourapplicationforahospitalpharmacylicenseisreceivedbytheDepartmentofHealth,youwillbenotifiedofanyoutstandingdocumentationneededtocompletetheapplication process.
Indicate type of application:
• New—First time requesting a hospital pharmacy license.
• Change of Ownership—When name of legal owner/operator changes resulting fromthesaleoflicensedhospitalpharmacy.
• Change of Location—Changingthelocationaddressofthehospitalpharmacy. Includeyourcurrentlicensenumber.
• Name Change Only—List your current facility name.
F Check One: Pleasecheckyourlegalowner/operatorbusinessstructuretypeaccordingtoyourWashington State Master Business License.
F Application Fees: Feesarenon-refundable.Youcanchecktheonlinefee page for current fees.
F 1. Demographic Information:
UniformBusinessIdentifierNumber(UBI#):Enter your Washington State UBI #.AllWashingtonStatebusinessesmusthaveUBI#’s.City,county,andstategovernmentdepartmentsalsohaveUBI#’s.
FederalIDNumber(FEIN#):EnteryourFederalIDNumber,ifthebusinesshasbeenissuedone.
Legal Owner/Operator Name: Enter the owner’s name as it appears on the UBI/Master Business License.
Mailing Address:Entertheowner’scompletemailingaddress.
Phone and Fax Numbers: Entertheowner’sphoneandfaxnumber.
EmailandWebAddress:Entertheowner’semailandagencyWebaddresses,ifthey have them.
Facility/Agency Name: Entertheagency’snameasadvertisedonsigns,brochures or Web sites.
Physical Address: Entertheagency’sphysicalstreetlocationincludingcity,state,zipcode,andcounty.
Emailaddress:Entertheagency’semailaddressifavailable.
Phone and Fax Numbers: Entertheagency’sphoneandfaxnumber.
Mailing Address: Entertheagency’smailingaddress,ifdifferentthanphysicaladdress.
DOH 690-301 September 2016 Page 2 of 2
F 2. Facility Information:
Hours Hospital Pharmacy will be open: Enter hours hospital pharmacy will be openMonday-Friday,Saturday,Sunday,andanyholidayhoursthatwillbeopen.
DrugEnforcementAdministration(DEA)RegistrationNumber: Enter the federalDEAregistrationnumberifdispensingcontrolledsubstances.Enter“pending”ifthepharmacyhasnotbeenissueditsDEAregistrationnumber.
Background Questions:Checkyesornoandifyoucheckyes,listandexplainona separate sheet of paper.
Pharmacist in Charge:Enterpharmacistname,licensenumber,dateofappointment,phonenumber,andemailaddress.
F 3. Contact Information: Entername,title,phonenumber,faxnumber,andemailaddress.
F 4. Additional Information:
Corporation information:Enterdateofincorporation,corporatenumber,andstateof corporation.
Legal Owner:Listthenames,titles,addresses,andphonenumbersofthecorporateofficers,partners,members,andmanagers.Attachadditionalcompletedpagesifyouneedmorespace.
Change of Ownership Information: List the previous legal owner name, previous nameoffacility,previouslicensenumber,andeffectivedateofownershipchange.
List of Pharmacists: List all pharmacists working in your pharmacy. Attach additionalcompletedpagesifyouneedmorespace.
F Signature:
Signatureoflegalownerorauthorizedrepresentative.
Datesigned.
Printnameoflegalownerorauthorizedrepresentative.
Printtitleoflegalownerorauthorizedrepresentative.
DateStampHere
Revenue: 0262010000
DOH 690-302 September 2016 Page 1 of 3
1. Demographic Information
Check One
UBI# FederalTaxID(FEIN)#
Legal Owner/Operator Name
MailingAddress
City State ZipCode County
Facility/AgencyName(BusinessnameasadvertisedonsignsorWebsite)
FacilityPhone(enter10digit#) Fax(enter10digit#)
Phone(enter10digit#) Fax(enter10digit#)
City State ZipCode County
PhysicalAddress
City State ZipCode County
MailingAddress(Ifdifferentthanphysicaladdress)
EmailAddress WebAddress:
FAssociationFCorporationF FederalGovernmentAgencyFLimitedLiabilityCompanyFLimitedLiabilityPartnership
F LimitedPartnershipF Municipality (City)F Municipality (County)F Non-ProfitCorporationF Partnership
F Sole ProprietorF StateGovernmentAgencyF TribalGovernmentAgencyFTrust
Thisisfor:F New F Change of Ownership F Change of Location – Current License # __________ F Name Change Only – Current Facility Name ______________________________________
Hospital Pharmacy License Application
EmailAddress:
2. Facility Information
3. Contact Information
DOH 690-302 September 2016 Page 2 of 3
Monday–Friday Saturday Sunday Holidays
Contact Person Name
Pharmacy Hours—Indicatethehoursthepharmacywillbeopen
1. Haveanyapplicants,partners,ormanagershadasuspension,revocation,orrestriction of a professional license? .........................................................................................................................FF
Ifyes,listandexplainonaseparatesheetofpaper.2. Haveanyapplicants,partners,ormanagersbeenfoundguiltyofadrugorcontrolled
substance violation? .................................................................................................................................FF Ifyes,listandexplainonaseparatesheetofpaper.
Background Questions YesNo
DrugEnforcementAdministration(DEA)RegistrationNumber
Pharmacist in Charge License Number Date of AppointmentPharmacist in Charge
DEANumber:_____________________________________
Title
Phone(enter10digit#) EmailAddress
Contact Person Name Title
Phone(enter10digit#) EmailAddress
Phone(enter10digit#) EmailAddress
DOH 690-302 September 2016 Page 3 of 3
Name License #List all Pharmacist–attach additional completed pages if you need more space.
Signature
IcertifyIhavereceived,read,understood,andagreetocomplywithstatelawandruleregulatingthislicensingcategory.Ialsocertifytheinformationhereinsubmittedistruetothebestofmyknowledgeandbelief.
SignatureofOwner/AuthorizedRepresentativeofPharmacy Date
Print Name Print Title
Previous Name of Legal Owner
Previous Name of Facility Previous Pharmacy License # Effective Date of Ownership Change
Change of Ownership Information
Date of Incorporation Corporate Number State of Corporation
Name Address Phone(enter10digit#) Title
5. Additional Information
Legal Owner Information–attach additional completed pages if you need more space.Listnames,addresses,phonenumbers,andtitlesofcorporateofficers,partners,membersandmanagers.
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Pharmacy Quality Assurance Commission PO Box 47877 Olympia, WA 98504-7863 360-236-4700
Washington State Methamphetamine Precursor Electronic Tracking System
NPLEx Account Activation
In2010theWashingtonLegislaturepassedRCW69.43.110torestrictthesaleandpurchaseofnon-prescriptionproductscontainingephedrine,pseudoephedrine,andphenylpropanolamineortheirsaltsor isomers, or salts of isomers.
Thelaw:
• Requirespharmaciestokeepproductscontainingmethamphetamineprecursorsbehindthecounterwherethepublicisnotpermittedorinalockeddisplaycasewhereitisnotaccessible to customers without assistance;
• Requirestheretailertorecordthenameandaddressofthepurchaser,thedateandtimeofthesale,thenameandtheinitialsofthepersonconductingthetransaction,thenameoftheproductsold,andthetotalquantityingramsoftheprecursorsbeingsold;
• Requiresthecustomertoelectronicallyormanuallysignarecordofanytransactionswhenpurchasing methamphetamine precursors;
• Updatesthesaleslimitstomatchthefederalrestrictions-dailysaleslimitof3.6gramsperpurchaserandprohibitsapurchaserfrombuyingmorethanninegramsduringa30-dayperiod;and
• Requires the Pharmacy Quality Assurance Commission to implement a real-time electronic sales tracking system.
* Rules:WAC246-869-070through120
Note:Ifyourpharmacysellsephedrine,pseudoephedrine,and/orphenylpropanolamineoverthecounter,youwillneedtosetupanaccounttoaccessandreporttotheNationalPrecursorLogExchange(NPLEx)byvisiting:https://nplex.appriss.com.
DOH 690-249 September 2016 Page 1 of 2
Notification to the commission of Pharmacy Opting Out of Electronic Reporting - NPLEx
Pleaseprovidetheinformationrequestedbelow(printortype.)
Name of Pharmacy Washington Pharmacy License Number
Address City State ZipCode
EmailAddress Phone(enter10digit#)
Name of Pharmacy Responsible Manager License Number of
NameofPersonCompletingform SignatureandDate
BysigningthisformIcertifythattheaforementionedpharmacy:
F Doesnotcurrentlysell,transfer,ortootherwisefurnishover-the-counterephedrine,pseudoephedrine,and/orphenylpropanolamineproducts.
F Currentlysells,transfers,orotherwisefurnishesephendrine,pseudoephedrine,and/orphenylpropanolaminecontainingproductsbyprescriptionsonly.
F Meets the exemption in RCW69.43.110andhassubmitteddocumentationtoshowgoodcausewhycompliancewiththeelectronicreportingwouldbeasignificanthardship.Apaperlogisbeingmaintainedpendingcommissionapproval.
Additionalcomments:
DOH 690-249 September 2016 Page 2 of 2
Thisisarequestforan:FOriginalExemptionRequest LengthofExemption(nottoexceed180days):____________________FExtensionRequest LengthofExemption(nottoexceed180days):____________________
Washington Methamphetamine Precursor Electronic Retail Sales Tracking System
Pharmacy Quality Assurance Commission PO Box 47877 Olympia, WA 98504-7863 360-236-4700
RequestforExemptionRevisedCodeofWashington69.43.110providesanexemptionfromtheWashingtonMethamphetaminePrecursor Electronic Retail Sales Tracking System (NPLEx) reporting requirements for retailers that can show goodcausewhytheycannotcomply.Retailerswhobelievetheyareeligibleunderthisprovisionmayapplyforan exemption with the Washington State Pharmacy Quality Assurance Commission. To request an exemption from compliance, complete all of the following information along with the signature of the retailer or person authorizedbytheretailer.Thecommissionwillreviewtherequestforexemptionandwillgrantordenytherequestwithin15businessdaysfromreceipt.Good causeconveysmustshowsignificanthardshiptocomplyasprescribedbylaw.Whatconstitutesagoodcausewillbedeterminedonacase-by-casebasis.Goodcause,includesbutisnotlimitedto,situationswherethe installation of the necessary equipment to access the system is unavailable or cost prohibitive to the retailer.
Credential Type:
FPharmacy CredentialNumber/DEACMEACertID_______________________________________ FItinerantVendor CredentialNumber/DEACMEACertID_______________________________________ FShopkeeper(endorsement) UBINumber/DEACMEACertID____________________________________________
Demographic Information:Legal Owner/Operator Name
MailingAddress
City State ZipCode County
Phone(enter10digit#) Fax(enter10digit#)
EmailAddress WebAddress
Facility/AgencyName(BusinessnameasadvertisedonsignsorWebsite)
City State ZipCode County
PhysicalAddress
Facilityphone(enter10digit#) Fax(enter10digit#)
MailingAddress(ifdifferentthanphysicaladdress)
DOH 690-222 September 2016 Page 1 of 2
Date Stamp Here
EmailAddress WebAddress
IattestthatIhavereceived,read,understood,andagreetocomplywithstatelawandruleregulatingthislicensecategory.Ialsoattestthattheinformationhereinsubmittedistruetothebestofmyknowledgeandbelief.Ialsounderstandthatthebusinessisrequiredtokeepawrittenlogofallpurchasetransactionsinvolvingrestrictedproductstoincludethefollowing:Dateandtimeofpurchase,productdescription;quantitysold(totalgrams,numberofboxes,etc.);purchaser’sfullname,dateofbirth,currentaddress,formofidentificationusedtoestablishage;identificationformnumber;purchaser’ssignatureandinitialsofthepersonmakingthesale.
__________________________________________________________ _____________________________
__________________________________________________________ _____________________________
SignatureofOwner/AuthorizedRepresentative Date(mm/dd/yyyy)
Print Name Print Title
DOH 690-222 September 2016 Page 2 of 2
Please send request to the address above.
JustificationforExemption: (includeadditionalsheetsandsupportingdocumentationifneededtoshowgoodcause)
Signature
Prescription Monitoring Program P.O. Box 47852Olympia WA [email protected]
DOH 631-020 September 2016
No Dispensing of Controlled Substances Registration
IfyourpharmacydoesnotdispensecontrolledsubstancestoWashingtonStateresi-dents,youcancompletetheNoDispensingofControlledSubstancesregistrationonlineandsubmitittothedepartment.Ifthedepartmentapprovesyourrequest,yourpharma-cywillnothavetofilezeroreportsforcompliancepurposes.Youwillneedtoresubmitthe registration each year when you renew your pharmacy license. By submitting an NDCSregistrationyou’llbecertifyingthat:
• Mypharmacydoesnotcurrentlydeliveranydrugscoveredbytheprogram(scheduleII,III,IV,orVcontrolledsubstancesoranyotherdrugsaddedbythePharmacyCommission)toultimateuserswhohaveaWashingtonStateaddress.
• IfourbusinesspracticechangesregardingdispensingdrugscoveredbytheprogramtoultimateuserswithaWashingtonStateaddress,wewillnotifytheWashingtonStateDepartmentofHealthandbegindatasubmissionasrequiredinRCW70.225.
• My pharmacy will resubmit this form every year with our pharmacy license renewal inordertore-certifythatthepharmacydoesnotdeliveranydrugscoveredbytheprogramtoultimateuserswhohaveaWashingtonStateaddress.
TheNDCSregistrationcanbeaccessedatwww.wapmp.org.Lookunderthe“WAPharmacy/PrescriberDataUploader”linkinthemenuontheleftofthepageandthenthe“NoDispensingofControlledSubstances”link.
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RCW/WAC LinksUniform Disciplinary Act, RCW18.130
UniformControlledSubstanceAct,RCW69.50
Administrativeproceduresandrequirements,WAC246-12
StandardsofProfessionalConduct,WAC246-16
PharmacyLaws,RCW18.64
PharmacyRules,WAC246-869
PharmaceuticalServices-ExtendedCareFacility,WAC246-865
HospitalStandards,WAC246-873
NuclearPharmaciesandPharmacist,WAC246-903
Pharmacy-AncillaryPersonnel,WAC246-901
LegendandPrescriptionDrugs,RCW69.41
PrecursorDrugs,RCW69.43
Pharmaceutical-PrecursorSubstance,WAC246-889
RegulationsImplementingtheUniformControlledSubstanceAct,WAC246-887
PrescriptionMonitoringProgramLaws,RCW70.225.020
PrescriptionMonitoringProgramRules,WAC246-470
On-LineAIDSTrainingResources,ReferencePage
PharmacyQualityAssuranceCommission,WebPage
RCW/WAC and Online Web Site Links
RCW/WACandOnlineWebSiteLinksSeptember2016