ML20247L667
| ML20247L667 | |
| Person / Time | |
|---|---|
| Issue date: | 05/15/1998 |
| From: | Paperiello C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | AFFILIATION NOT ASSIGNED |
| Shared Package | |
| ML20247L672 | List: |
| References | |
| NUDOCS 9805260040 | |
| Download: ML20247L667 (5) | |
Text
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May 15, 1998 TO ALL NRC MEDICAL LICENSEES, COMMERCIAL NUCLEAR PHARMACIES AND RADIOPHARMACEUTICAL MANUFACTURERS Enclosed is a 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. Until further notice, 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.
This Notice of Intent to Exercise Temporary Enforcement Discretion does not relieve licensees from current molybdenum-99 breakthrough testing requirements, other applicable NRC requirements, or maintaining comp;iance with applicable Food and Drug Administration, other Federal, and State requirements goveming radioactive drugs.
Because this Notice of Intent to Exercise Temporary Enforcement Discretion is effective immediately, it is important that you notify your appropriate personnel immediately, and retain this Notice of intent to Exercise Temporary Enforcement Discretion with your license records.
Questions and comments may be directed to your nearest NRC regional office.
This Notice of Intent to Exercise Temporary Enforcement Discretion is effective until further notice.
Sincerely, originial signed by William Kane Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards
Enclosure:
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 To roc.sve a copy of this document, indicate in the box.
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/ 19 8 9805260040 980515 PDR 18 E HISC PDR
URGENT TO ALL NRC MEDICAL LICENSEES, COMMERCIAL NUCLEAR PHARMAClES AND RADIOPHARMACEUTICAL MANUFACTURERS Enclosed is a 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. Until further notice, the Nuclear Regulatory Commission 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.
This Notice of Intent to Exercise Temporary Enforcement Discretion does not relieve licensees from current molybdenum-99 breakthrough testing requirements, other applicable NRC requirements, or maintaining compliance with applicable FDA, other Federal, and State requirements governing radioactive drugs.
Because this Notice of Intent to Exercise Temporary Enforcement Discretion is effective immediately, it is important that you notify your appropriate personnel immediately, and retain this Notice of Intent to Exercise Temporary Enforcement Discretion with your license records.
Questions and comments may be directed to your nearest NRC regional office.
This Notice of Intent to Exercise Temporary Enforcement Discretion,is' effective until further notice.
Sincerely, Carl J. Papdriello, Director Office of Nuclear Material Safety and Safeguards
Enclosure:
Notice of Intent to Exercise Temporary Enforcement Discretion DISTRIBUTION:G:\\dbh\\ pharmacy \\ waiver
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URGENT s
a' TO ALL NRC MEDICAL LICENSEES, COMMERCIAL NUCLEAR PHARMAClES AND RADIOPHARMACEUTICAL MANUFACTURERS Enclosed is a Notice of Intent to Exercise Temporary Enforcement Discretion for licen/
sees-authorized to possess and use molybdenum-99 for the manufacture of molybdendm-99/ technetium-99m generators and to possess and use molybdenum-99/techn'etium-99m generators. Until further notice, the Nuclear Regulatory Commission will not enforce license conditions or regulations restricting radiopharmaceutical manufacturing, commercial nuclear -
pharmacy, and medicel use licensees' possession limits for molybdenurn-99 for production of molybdenum-99/ technetium-99m generators, or possession limits for molybdenum-99/ technetium-99m generators.
This Notice of Intent to Exercise Temporary Enforcement Discrotion does not relieve licensees -
from current molybdenum-99 breakthrough testing requirements, other applicable NRC requirements, or maintaining compliance with applicable FDA, other Federal, and State requirements governing radioactive drugs.
j l
Because this Notice of intent to Exercise Temporary Enforcement Discretion is effective immediately, it is important that you notify your appropriate personnel immediately, and retain this Notice of Intent to Exercise Temporary Enforcement Discretion with your license records.
Questions and comments may be directed to yodr nearest NRC regional office.
This Notice of Intent to Exercise Temporary Enforcement Discretion is effective until further notice.
/ Sincerely,
?
/
Carl J. Paperiello, Director
/
Office of Nuclear Material Safety
/
and Safeguards
Enclosure:
Notice of Intent to Exercise Temporary Enforcement Discretion DISTRIBUTION:G:\\dbh\\ pharmacy \\ waiver NRC Central File IMNS r/f NMSS r/f PDR:YES X NO opy
- E' w swene v No copy *See proveus concunence oFC MSB*
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- ,o May 15, 1998 1
URGENT TO ALL NRC MEDICAL LICENSEES, COMMERCIAL NUCLEAR PHARMAClES AND RADIOPHARMACEUTICAL MANUFACTURERS Enclosed is a 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. Until further notice, 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.
This Notice of Intent to Exercise Temporary Enforcement Discretion does not relieve licensees from current molybdenum-99 breakthrough testing requirements, other applicable NRC requirements, or maintaining corppliance with applicable Food and Drug Administration, other
- Federal, and State requirements goveming radioactive drugs.
Because this Notice of Intent to Exercise Temporary Enforcement Discretion is effective immediately, it is important that you notify your appropriate personnel immediately, and retain this Notice of Intent to Exercise Temporary Enforcement Discretion with your license records.
Questions and comments may be directed to your nearest NRC regional office.
This Notice of Intent to Exercise Temporary Enforcement Discretion is effective until further notice.
Sincere!
a t
Carl J. Papenello, Director Office of Nuclear Material Safety and Safeguards
Enclosure:
Notice of intent to Exercise Temporary Enforcement Discretion l
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May 15, 1998 URGENT TO ALL NRC MEDICAL LICENSEES, COMMERCIAL NUCLEAR PHARMAClES AND RADIOPHARMACEUTICAL MANUFACTURERS Enclosed is a 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. Until further notice, the Nuclear Regulatory Commission (NRC) will not enforce license conditions or regulations restricting radiopharmaceutical manufacturing, commercial nuclear pharmacy, and medical uso licensees' possession limits for molybdenum-99 for production of molybdenum-99/ technetium-99m generators, or possession limits for molybdenum-99/ technetium-99m generators.
This Notice of Intent to Exercise Temporary Enforcement Discretion does not relieve licensees from current molybdenum-99 breakthrough testing requirements, other applicable NRC requirements, or maintaning compliance with applicable Food and Drug Administration, other Federal, and State requirements governing radioactive drugs.
Because this Notice of Intent to Exercise Temporary Enforcement Discretion is effective immediately, it is important that you notify your appropriate personnel immediately, and retain this Notice of Intent to Exercise Temporary Enforcement Discretion with your license records.
Questions and comments may be directed to your nearest NRC regional office.
This Notice of intent to Exercise Temporary Enforcement Discretion is effective until further notice.
Sincerel Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards l
l
Enclosure:
Notice of Intent to Exercise Temporary Enforcement Discretion 1
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