The following pages contain the Routes of Administration ICH M5 Controlled Vocabulary. 065. UNKNOWN. UNKNOWN USE. UNKNOWN / UNASSIGNED INJECTION (NOT.
ich m ewg routes administration controlled vocabulary step en
Jul 22 2020 Pharmaceutical Dose Forms (DF) and Routes of Administration (RoA) in E2B(R3) ... Dose Form) for DF
Nov 16 2018 Pharmaceutical dose form (i.e. the dosage form)
standard terms introduction and guidance for use
Dosage route of administration
scs freamine lbl
Medicine & Administration. Medicines & Infusion Protocols (Adults) 014-001-01-065. Authorised by ... Unlicensed route of administration: • Subcutaneous ...
Clonazepam PalliativeCareJun
EMEA/CVMP/065/99 – FINAL the type of container route of administration and patient/userbenefit have contributed to the choice of a particular container.
superseded annex note guidance development pharmaceutics veterinary products decision trees en
Approved by FDA under NADA # 065-010NOROCILLIN(penicillin G
Dosage: Norocillin is administered by the intramuscular route. The product is ready for injection after warming the vial to room temperature and shaking to
The standard terminology on pharmaceutical dose forms and routes of administration as maintained by the European Directorate for the Quality of Medicines &
european union individual case safety report icsr implementation guide en
Dec 16 2021 041-6270
Div Div Div Div TrackedChanges
FHWA-HRT-22-065. MAY 2022 The Federal Highway Administration (FHWA) provides high-quality ... UHPC beam end repair on the Route 6/10 Interchange Bridge.
214950
PERMANENT ADMINISTRATIVE ORDER
BP 45-2021
CHAPTER 855
BOARD OF PHARMACY
FILED12/16/2021 3:53 PM
ARCHIVES DIVISION
SECRETARY OF STATE
& LEGISLATIVE COUNSEL
FILING CAPTION: Proactive procedural rule review.
EFFECTIVE DATE: 12/16/2021
AGENCY APPROVED DATE: 12/09/2021
CONTACT: Rachel Melvin
971-673-0001
pharmacy.rulemaking@bop.oregon.gov800 NE Oregon St., Suite 150
Portland,OR 97232Filed By:
Rachel Melvin
Rules Coordinator
RULES:
855-007-0120, 855-041-1001, 855-041-1035, 855-041-1040, 855-041-1080, 855-041-1130, 855-041-1145, 855-041-6270, 855-045-0200, 855-045-0220, 855-045-0240, 855-065-0005
AMEND: 855-007-0120
NOTICE FILED DATE: 10/25/2021
RULE SUMMARY: Procedural rules revisions to ensure clarity, transparency and promote patient safety.
CHANGES TO RULE:
Page 1 of 15
'HILQLWLRQVx %LRORJLFDOSURGXFWPHDQVZLWKUHVSHFWWRWKHSUHYHQWLRQWUHDWPHQWRUFXUHRIDGLVHDVHRUFRQGLWLRQRI KXPDQEHLQJVDYLUXVWKHUDSHXWLFVHUXPWR[LQDQWLWR[LQYDFFLQHEORRGEORRGFRPSRQHQWEORRGGHULYDWLYH DOOHUJHQLFSURGXFWSURWHLQRWKHUWKDQDFKHPLFDOO\V\QWKHVL]HGSRO\SHSWLGHDQDORJRXVSURGXFWVRUDUVSKHQDPLQH
RUDQ\RWKHUWULYDOHQWRUJDQLFDUVHQLFFRPSRXQGx
%LRVLPLODUSURGXFWPHDQVDELRORJLFDOSURGXFWOLFHQVHGE\WKH8QLWHG6WDWHV)RRGDQG'UXJ$GPLQLVWUDWLRQ
SXUVXDQWWR86&6&N$Lx
'UXJURRPLVDGUXJVWRUDJHDUHDUHJLVWHUHGZLWKWKH%ERDUGZKLFKLVVHFXUHDQGORFNDEOHx ,QWHUFKDQJHDEOHPHDQVLQUHIHUHQFHWRDELRORJLFDOSURGXFWWKDWWKH8QLWHG6WDWHV)RRGDQG'UXJ $GPLQLVWUDWLRQKDVGHWHUPLQHGWKDWDELRVLPLODUSURGXFWPHHWVWKHVDIHW\VWDQGDUGVVHWIRUWKLQ86&6& Nx
5HIHUHQFHELRORJLFDOSURGXFWPHDQVWKHELRORJLFDOSURGXFWOLFHQVHGSXUVXDQWWR86&6&D
DJDLQVWZKLFKDELRORJLFDOSURGXFWLVHYDOXDWHGLQDQDSSOLFDWLRQVXEPLWWHGWRWKH8QLWHG6WDWHV )RRGDQG'UXJ$GPLQLVWUDWLRQIRUOLFHQVXUHRIDELRORJLFDOSURGXFWDVDELRVLPLODUSURGXFWRUIRUGHWHUPLQDWLRQ
WKDWDELRVLPLODUSURGXFWLVLQWHUFKDQJHDEOHx
5HSDFNDJHPHDQVWKHDFWRIWDNLQJDGUXJIURPWKHFRQWDLQHULQZKLFKLWZDVGLVWULEXWHGE\WKHPDQXIDFWXUHU
DQGSODFLQJLWLQWRDGLIIHUHQWFRQWDLQHUZLWKRXWIXUWKHUPDQLSXODWLRQRIWKHGUXJ
6WDWXWRU\2WKHU$XWKRULW\256256
6WDWXWHV2WKHU,PSOHPHQWHG256256
Page 2 of 15
0LQLPXP(TXLSPHQW5HTXLUHPHQWV%RWK5HWDLODQG,QVWLWXWLRQDO'UXJ2XWOHWVx
7KHPLQLPXPHTXLSPHQWUHTXLUHPHQWWRRSHQDQGRSHUDWHDUHWDLOGUXJRXWOHWDQGLQVWLWXWLRQDOGUXJRXWOHWLQWKH
VWDWHRI2UHJRQVKDOOFRQVLVWRIQRWOHVVWKDQ(DFKUHWDLOGUXJRXWOHWDQGLQVWLWXWLRQDOGUXJRXWOHWPXVWKDYHWKH
IROORZLQJx
D7KHPRVWFXUUHQWLVVXHRIDWOHDVWRQHSKDUPDFHXWLFDOUHIHUHQFHZLWKFXUUHQWSURSHUO\ILOHGVXSSOHPHQWVDQG XSGDWHVDSSURSULDWHWRDQGEDVHGRQWKHVWDQGDUGVRISUDFWLFHIRUWKHVHWWLQJ$SSURSULDWHDQGFXUUHQW SKDUPDFHXWLFDOUHIHUHQFHVHJSKDUPDFRORJ\LQMHFWDEOHVDQGYHWHULQDU\GUXJVEDVHGRQVHUYLFHVRIIHUHGE\WKH
RXWOHWx
E&XUUHQWDQGSURSHUO\ILOHG2UHJRQ5HYLVHG6WDWXWHV&KDSWHUVDQGFXUUHQWDQGSURSHUO\ILOHG
2UHJRQ$GPLQLVWUDWLYH5XOHVFKDSWHUDQGDPLQLPXPRIWKUHH\HDUVRIWKH%RDUGRI3KDUPDF\TXDUWHUO\
QHZVOHWWHUVPDLQWDLQHGLQKRX$SSURSULDWHDQGFXUUHQW2UHJRQ5HYLVHG6WDWXWHV2UHJRQ$GPLQLVWUDWLYH5XOHV
8QLWHG6WDWHV&RGH&RGHRI)HGHUDO5HJXODWLRQVVWDQGDUGVDGRSWHGE\UHIHUHQFHHJ863EDVHGRQVHUYLFHV
RIIHUHGE\WKHRXWOHWDQGDPLQLPXPRIWKUHH\HDUVRIWKH%RDUGRI3KDUPDF\TXDUWHUO\QHZVOHWWHUVx F$FFHVVWRDSSURSULDWHHOHFWURQLFUHSRUWLQJGDWDEDVHVHJ3'0313/([2+$$/(57,,6EDVHGRURWKHU UHDGLO\UHWULHYDEOHPHDQVQWKHVHUYLFHVRIIHUHGE\WKHRXWOHWx G$SSURSULDWHHTXLSPHQWWRPDLQWDLQWKHSURSHUVWRUDJHRIGUXJVx H2IILFLDO3RLVRQDQG([HPSW1DUFRWLF$SSURSULDWHHTXLSPHQWDQGVXSSOLHVDVUHTXLUHGE\2UHJRQ5HJYLVWHULI
SRLVRQVDQGH[HPSWQDUFRWLFVDUHVROGRUGLVWULEXWHGx
6XLWDEOHUHIULJHUDWLRQHG6WDWXWHV2UHJRQ$GPLQLVWUDWLYH5XOHV8QLWHG6WDWHV&RGH&RGHRI)HGHUDO
5HJXODWLRQVDQGVWDQGDUGVDGRSWHGE\UHIHUHQFHHJ863EDVHGRQVHUYLFHVRIIHUHGE\WKHRXWOHWx
I$VLQNZLWKUXQQLQJKRWDQGFROGZDWHUx
J(TXLSPHQWDQGVXSSOLHVDSSURSULDWHWRDQGEDVHGRQWKHVWDQGDUGVRISUDFWLFHIRUWKHVHWWLQJDVGHWHUPLQHG
E\WKH3KDUPDF\DQG3KDUPDFLVWLQ&KDUJHx
)DLOXUHWRKDYHDQGXVH6LJQDJHLQDORFDWLRQHDVLO\VHHQE\WKHSXEOLFZKHUHSUHVFULSWLRQVDUHGLVSHQVHGRU
DGPLQLVWHUHGx
$6WDWLQJ7KLVSKDUPDF\PD\EHDEOHWRVXEVWLWXWHDOHVVH[SHQVLYHGUXJZKLFKLVWKHUDSHXWLFDOO\HTXLSPYDOHQW QHFHVVDU\WR\RXUSUDFWLFHVHWWRWKHRQHSUHVFULEHGE\\RXUGRFWRUXQOHVV\RXGRQRWDSSURYH7KHSULQWLQJ FRQVWLWXWKLVVLJQPXVWEHLQEORFNOHWWHUVXQSURIHVVLRQDOFRQGXFWIRUSXUSRVHVRI256Dx ,IDQRXWOHWILOHVRULJLQDOSUHVFULSWLRQVHOHFWURQLFDOO\WKHQWKHRXWOHWPXVWKDYHDFRPSXWHUDQGVRIWZDUH
PERMANENT ADMINISTRATIVE ORDER
BP 45-2021
CHAPTER 855
BOARD OF PHARMACY
FILED12/16/2021 3:53 PM
ARCHIVES DIVISION
SECRETARY OF STATE
& LEGISLATIVE COUNSEL
FILING CAPTION: Proactive procedural rule review.
EFFECTIVE DATE: 12/16/2021
AGENCY APPROVED DATE: 12/09/2021
CONTACT: Rachel Melvin
971-673-0001
pharmacy.rulemaking@bop.oregon.gov800 NE Oregon St., Suite 150
Portland,OR 97232Filed By:
Rachel Melvin
Rules Coordinator
RULES:
855-007-0120, 855-041-1001, 855-041-1035, 855-041-1040, 855-041-1080, 855-041-1130, 855-041-1145, 855-041-6270, 855-045-0200, 855-045-0220, 855-045-0240, 855-065-0005
AMEND: 855-007-0120
NOTICE FILED DATE: 10/25/2021
RULE SUMMARY: Procedural rules revisions to ensure clarity, transparency and promote patient safety.
CHANGES TO RULE:
Page 1 of 15
'HILQLWLRQVx %LRORJLFDOSURGXFWPHDQVZLWKUHVSHFWWRWKHSUHYHQWLRQWUHDWPHQWRUFXUHRIDGLVHDVHRUFRQGLWLRQRI KXPDQEHLQJVDYLUXVWKHUDSHXWLFVHUXPWR[LQDQWLWR[LQYDFFLQHEORRGEORRGFRPSRQHQWEORRGGHULYDWLYH DOOHUJHQLFSURGXFWSURWHLQRWKHUWKDQDFKHPLFDOO\V\QWKHVL]HGSRO\SHSWLGHDQDORJRXVSURGXFWVRUDUVSKHQDPLQH
RUDQ\RWKHUWULYDOHQWRUJDQLFDUVHQLFFRPSRXQGx
%LRVLPLODUSURGXFWPHDQVDELRORJLFDOSURGXFWOLFHQVHGE\WKH8QLWHG6WDWHV)RRGDQG'UXJ$GPLQLVWUDWLRQ
SXUVXDQWWR86&6&N$Lx
'UXJURRPLVDGUXJVWRUDJHDUHDUHJLVWHUHGZLWKWKH%ERDUGZKLFKLVVHFXUHDQGORFNDEOHx ,QWHUFKDQJHDEOHPHDQVLQUHIHUHQFHWRDELRORJLFDOSURGXFWWKDWWKH8QLWHG6WDWHV)RRGDQG'UXJ $GPLQLVWUDWLRQKDVGHWHUPLQHGWKDWDELRVLPLODUSURGXFWPHHWVWKHVDIHW\VWDQGDUGVVHWIRUWKLQ86&6& Nx
5HIHUHQFHELRORJLFDOSURGXFWPHDQVWKHELRORJLFDOSURGXFWOLFHQVHGSXUVXDQWWR86&6&D
DJDLQVWZKLFKDELRORJLFDOSURGXFWLVHYDOXDWHGLQDQDSSOLFDWLRQVXEPLWWHGWRWKH8QLWHG6WDWHV )RRGDQG'UXJ$GPLQLVWUDWLRQIRUOLFHQVXUHRIDELRORJLFDOSURGXFWDVDELRVLPLODUSURGXFWRUIRUGHWHUPLQDWLRQ
WKDWDELRVLPLODUSURGXFWLVLQWHUFKDQJHDEOHx
5HSDFNDJHPHDQVWKHDFWRIWDNLQJDGUXJIURPWKHFRQWDLQHULQZKLFKLWZDVGLVWULEXWHGE\WKHPDQXIDFWXUHU
DQGSODFLQJLWLQWRDGLIIHUHQWFRQWDLQHUZLWKRXWIXUWKHUPDQLSXODWLRQRIWKHGUXJ
6WDWXWRU\2WKHU$XWKRULW\256256
6WDWXWHV2WKHU,PSOHPHQWHG256256
Page 2 of 15
0LQLPXP(TXLSPHQW5HTXLUHPHQWV%RWK5HWDLODQG,QVWLWXWLRQDO'UXJ2XWOHWVx
7KHPLQLPXPHTXLSPHQWUHTXLUHPHQWWRRSHQDQGRSHUDWHDUHWDLOGUXJRXWOHWDQGLQVWLWXWLRQDOGUXJRXWOHWLQWKH
VWDWHRI2UHJRQVKDOOFRQVLVWRIQRWOHVVWKDQ(DFKUHWDLOGUXJRXWOHWDQGLQVWLWXWLRQDOGUXJRXWOHWPXVWKDYHWKH
IROORZLQJx
D7KHPRVWFXUUHQWLVVXHRIDWOHDVWRQHSKDUPDFHXWLFDOUHIHUHQFHZLWKFXUUHQWSURSHUO\ILOHGVXSSOHPHQWVDQG XSGDWHVDSSURSULDWHWRDQGEDVHGRQWKHVWDQGDUGVRISUDFWLFHIRUWKHVHWWLQJ$SSURSULDWHDQGFXUUHQW SKDUPDFHXWLFDOUHIHUHQFHVHJSKDUPDFRORJ\LQMHFWDEOHVDQGYHWHULQDU\GUXJVEDVHGRQVHUYLFHVRIIHUHGE\WKH
RXWOHWx
E&XUUHQWDQGSURSHUO\ILOHG2UHJRQ5HYLVHG6WDWXWHV&KDSWHUVDQGFXUUHQWDQGSURSHUO\ILOHG
2UHJRQ$GPLQLVWUDWLYH5XOHVFKDSWHUDQGDPLQLPXPRIWKUHH\HDUVRIWKH%RDUGRI3KDUPDF\TXDUWHUO\
QHZVOHWWHUVPDLQWDLQHGLQKRX$SSURSULDWHDQGFXUUHQW2UHJRQ5HYLVHG6WDWXWHV2UHJRQ$GPLQLVWUDWLYH5XOHV
8QLWHG6WDWHV&RGH&RGHRI)HGHUDO5HJXODWLRQVVWDQGDUGVDGRSWHGE\UHIHUHQFHHJ863EDVHGRQVHUYLFHV
RIIHUHGE\WKHRXWOHWDQGDPLQLPXPRIWKUHH\HDUVRIWKH%RDUGRI3KDUPDF\TXDUWHUO\QHZVOHWWHUVx F$FFHVVWRDSSURSULDWHHOHFWURQLFUHSRUWLQJGDWDEDVHVHJ3'0313/([2+$$/(57,,6EDVHGRURWKHU UHDGLO\UHWULHYDEOHPHDQVQWKHVHUYLFHVRIIHUHGE\WKHRXWOHWx G$SSURSULDWHHTXLSPHQWWRPDLQWDLQWKHSURSHUVWRUDJHRIGUXJVx H2IILFLDO3RLVRQDQG([HPSW1DUFRWLF$SSURSULDWHHTXLSPHQWDQGVXSSOLHVDVUHTXLUHGE\2UHJRQ5HJYLVWHULI
SRLVRQVDQGH[HPSWQDUFRWLFVDUHVROGRUGLVWULEXWHGx
6XLWDEOHUHIULJHUDWLRQHG6WDWXWHV2UHJRQ$GPLQLVWUDWLYH5XOHV8QLWHG6WDWHV&RGH&RGHRI)HGHUDO
5HJXODWLRQVDQGVWDQGDUGVDGRSWHGE\UHIHUHQFHHJ863EDVHGRQVHUYLFHVRIIHUHGE\WKHRXWOHWx
I$VLQNZLWKUXQQLQJKRWDQGFROGZDWHUx
J(TXLSPHQWDQGVXSSOLHVDSSURSULDWHWRDQGEDVHGRQWKHVWDQGDUGVRISUDFWLFHIRUWKHVHWWLQJDVGHWHUPLQHG
E\WKH3KDUPDF\DQG3KDUPDFLVWLQ&KDUJHx
)DLOXUHWRKDYHDQGXVH6LJQDJHLQDORFDWLRQHDVLO\VHHQE\WKHSXEOLFZKHUHSUHVFULSWLRQVDUHGLVSHQVHGRU
DGPLQLVWHUHGx
$6WDWLQJ7KLVSKDUPDF\PD\EHDEOHWRVXEVWLWXWHDOHVVH[SHQVLYHGUXJZKLFKLVWKHUDSHXWLFDOO\HTXLSPYDOHQW QHFHVVDU\WR\RXUSUDFWLFHVHWWRWKHRQHSUHVFULEHGE\\RXUGRFWRUXQOHVV\RXGRQRWDSSURYH7KHSULQWLQJ FRQVWLWXWKLVVLJQPXVWEHLQEORFNOHWWHUVXQSURIHVVLRQDOFRQGXFWIRUSXUSRVHVRI256Dx ,IDQRXWOHWILOHVRULJLQDOSUHVFULSWLRQVHOHFWURQLFDOO\WKHQWKHRXWOHWPXVWKDYHDFRPSXWHUDQGVRIWZDUH