ML20248K322
| ML20248K322 | |
| Person / Time | |
|---|---|
| Issue date: | 06/03/1998 |
| From: | Knapp M NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | AFFILIATION NOT ASSIGNED |
| Shared Package | |
| ML20248K324 | List: |
| References | |
| NUDOCS 9806100072 | |
| Download: ML20248K322 (3) | |
Text
- _ - _ __
w i:v URGENT June 3, 1998 TO ALL NRC MEDICAL LICENSEES, COMMERCIAL NUCLEAR PHARMAClES AND RADIOPHARMACEUTICAL MANUFACTURERS Enclosed is a Notice of Termination of the May 15,1998, " Notice of Intent to Exercise Temporary Enforcement Discretion" for licensees authorized to possess and use molybdenum-99 for the manufacture of molybdenum-99/ technetium-99m generators and to
= possess and use molybdenum-99/ technetium-99m generators. The Nuclear Regulatory Commission (NRC) will not enforce license conditions or regulations restricting radiopharmaccutical manufacturing, commercial nuclear pharmacy, and medical use licensees'
. possession limits for molybdenum-99 for production of molybdenum-99/ technetium-99m generators, or possession limits for molybdenum-99/ technetium-99m generators for the period from May 15,1998, until June 15,1998.
i This Notice of Termination does not relieve licensees from license conditions or regulations restmting possession limits for molybdenum-99 for production of molybdenum-99/
technetium-99m generators, or possession limits for molybdenum-99/ technetium-99m generators before May 15,1998, or after June 15,1998.. Licensees are not relieved from other applicable NRC requirements, or compliance with applicable Food and Drug Administration, other Federal, and State requirements governing radioactive drugs, before, during, or after the effective period of the May 15,1998, " Notice of Intent to Exercise Temporary Enforcement Discretion."
Because this Notice of Termination is effective June 15,1998, it is important that you notify your appropriate personnel immediately, and retain this Notice of Termination with your license records. Questions and comments may be directed to your NRC regional office.
Sincerely, iginial signed by MKnapp or Malcolm R. Knapp, Acting Director Office of Nuclear Material Safety and Safeguards
Enclosure:
Notice of Termination of the May 15,1998. " Notice of Intent to Exercise Temporary Enforcement Discretion"
\\]
DISTRIBUI1QN.
DNRC% file g IMNS r/f Gqpjjg I
g NMSS r/f NMSS Dir. Off. r/f-gh @5 PDR: YES ' X NO fa receive e copy of aus document,insesse in me bor see previous concurrences
- c copyeenvenew copywmuenem.NocopyG:\\dbh\\ pharmacy \\waiveme op/enoorso/Juma a, sese
\\DEDQ OFC MSB*
MSB*
IMNS*
OGC*
OE' MNSS NAME' DBHowe/mf
' LCamper FCombs
' JGoldberg JLieberman ompson
' DATE --
1 /02/98 6/02198 -
6/ 02/98 6/02198 6/02 /98
. 6/
/98 6
LFFICIAL RECORD COPY -
p IMNs/sEc '
- .
- ,f
,. g M f
}.
'dMagn ;l==
'!PA TJ CEnlTER 80PF
~~
- \\
_ _ _____-_ _ _ w
URGENT
/
TO ALL NRC MEDICAL LICENSEES, COMMERCIAL NUCLEAR PHARMACIES AND RADIOPHARMACEUTICAL MANUFACTURERS
/
Enclosed is a Notice of Termination of the May 15,1998, " Notice of Intent to Ex5rcise Temporary Enforcement Discretion" for licensees authorized to possess and use molybddnum-99 for the manufacture of molybdenum-99/ technetium-99m generators and to possesf, and use molybdenum-99/ technetium-99m generators. The Nuclear Regulatory Commission (,NRC) will not enforce license conditions or regulations restricting radiopharmaceutical manufacturing, commercial nuclear pharmacy, and medical use licensees' possession limits for molybdefium-99 for production of molybdenum-99/ technetium-99m generators, or possession limitsfor molybdenum-99/
technetium-99m generators for the period from May 15,1998 until June 8,1998.
This Notice of Termination does not relieve licensees from) nse conditions or regulations restricting possession limits for molybdenum-99 for proddction of molybdenum-99/
technetium-99m generators, or possession limits for mofybdenum-99/ technetium-99m generators before May 15,1998 or after June 8,19 Licensees are not relieved from other applicable NRC requirements, or compliance with a plicable Food and Drug Administration, other Federal, and State requirements governin dioactive drugs, before during, or after the effective period of the May 15,1998, "Nc' ice of) tent to Exercise Temporary Enforcement Discretion".
Because this Notice of Termination is effec e June 8,1998, it is important that you notify your appropriate personnel immediately, and r ain this Notice of Termination with your license records. Questions and comments may e directed to your NRC regional office.
Sincerely, Malcom R. Knapp, Acting Director Office of Nuclear Material Safety and Safeguards
Enclosure:
Notice of Termination ofd e May 15,1998, ' Notice of Intent to Exercise Temporary Enforcement Discretion" DISTRIBUTION:
NRC Central File IMNS r/f NMSS r/f NMSS Dir. Off. r/f PDR: YES X NO m.c.n,.. cm at n. oocum nt mo.cm. m m. i>ar c cm..w.nci r cm uw.nciv mem G:\\dbh\\phymacy\\ waiver 1.neg ? 'p/ff(D oFC MSB D
,f
/
i i
C MNSS DEDO NAME DBH w /n OC b
d o
rg JL erman MKnapp HThompson 6/ //,4I8 6/
/98
_DATE 6/ O /98 6/ /98 6
/98 6/
/98 OFFICIAL RECORD COPY IMNs/SEC l
/ /98
nouq k
UNITED STATES p~
g g
NUCLEAR REGULATORY COMMISSION 2
WASHINGTON, D.C. 20066 0001 June 3, 1998 l
l URGENT TO ALL NRC MEDICAL LICENSEES, COMMERCIAL NUCLEAR PHARMACIES AND RADIOPHARMACEUTICAL MANUFACTURERS Enclosed is a Notice of Termination of the May 15,1998, " Notice of Intent to Exercise Temporary Enforcement Discretion" for licensees authorized to possess and use molybdenum-99 for the manufacture of molybdenum-99/ technetium-99m generators and to possess and use molybdenum-99/ technetium-99m generators. The Nuclear Regulatory Commission (NRC) will not enforce license conditions or regulations restricting radiopharmaceutical manufacturing, commercial nuclear pharmacy, and medical use licensees' possession limits for molybdenum-99 for production of molybdenum-99/ technetium-99m generators, or possession limits for molybdenum-99/ technetium-99m generators for the period from May 15,1998, until June 15,1998.
This Notice of Termination does not relieve licensees from license conditions or regulations restricting possession limits for molybdenum-99 for production of molybdenum-99/
technetium-99m generators, or possession limits for molybdenum-99/ technetium-99m generators before May 15,1998, or after June 15,1998. Licensees are not relieved from other applicable NRC requirements, or compliance with applicable Food and Drug Administration, other Federal, and State requirements governing radioactive drugs, before, during, or after the effective period of the May 15,1998, " Notice of Intent to Exercise Temporary Enforcement Discretion."
Because this Notice of Termination is effective June 15,1998, it is important that you notify your appropriate personnel immediately, and retain this Notice of Termination with your license records. Questions and comments may be directed to your NRC regional office.
Sincerely,
/k Malcolm R. Knapp, A ting Director Office of Nuclear Material Safety and Safeguards 1
Enclosure:
Notice of Termination of the May 15,1998, " Notice of Intent to Exercise Temporary Enforcement Discretion" a