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FM CMC WASHINGTON DC//LP//
TO MARADMIN
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UNCLAS //N04400//
MARADMIN 494/01
MSGID/GENADMIN/CMC WASHINGTON DC/LP/LPC-4//
SUBJ/PROCEDURES FOR CARE IN STORAGE OF PHARMACEUTICALS//
REF/A/DOC/DODIG report no. 99-201/2 JUL 99//
REF/B/DOC/DOD 4140.27-M//
REF/C/DOC/BUMEDINST 6710.62A//
REF/D/DOC/DOD 4160.21-M//
NARR/REF A IS DODIG , FINAL REPORT ON WAR RESERVE AND PRE-POSITIONED
MEDICAL MATERIEL. REF B, BUMEDINST 6710.62A. IS THE MARINE CORPS
WAREHOUSING MANUAL. REF C IS THE MANAGEMENT DISPOSAL OF DATED
MEDICAL AND DENTAL MATERIEL. REF D IS THE DOD SHELF LIFE MANAGEMENT
MANUAL. REF E IS THE DEFENSE MATERIEL DISPOSITION MANUAL CHAPTER.//
POC/M. J. READING/CDR/LPC-4/DSN:225-8926/TEL:703-695-8936
/E-MAIL:READINGMJ@HQMC.USMC.MIL//
POC/F. J. LEPE/HMC/LPC-4/DSN:225-8926/TEL:703-695-8936
/E-MAIL:LEPEFJ@HQMC.USMC.MIL//
RMKS/1. BACKGROUND. REF A, IDENTIFIED A DISCREPANCY IN THE USMC
STORAGE AND MANAGEMENT OF PHARMACEUTICALS. SPECIFICALLY,
PHARMACEUTICALS ARE NOT BEING MONITORED TO ENSURE THAT TEMPERATURE
AND HUMDITY (T/H) WITHIN WAREHOUSES ARE MAINTAINED WITHIN
MANUFACTURER LABEL GUIDELINES. THE LACK OF T/H MONITORING
CAPABILITY MAY RESULT IN IMPROPER STORAGE OF MEDICINES. INADEQUATE
PRESERVATIVE MEASURES TO PREVENT DETERIORATION OF ITEMS RESULTING
FROM EXPOSURE TO ATMOSPHERIC CONDITIONS DURING STORAGE CAN RESULT
IN DEGRADATION OF A PHARMACEUTICAL'S EFFICACY. REF B PROVIDES
ADDITIONAL WAREHOUSING INFORMATION. PHARMACEUTICAL STORAGE AND
MANAGEMENT PROCEDURES AND GUIDELINES ARE NECESSARY TO MINIMIZE LOSS
OF INVENTORY DUE TO IMPROPER STORAGE AND TO PRECLUDE ADVERSE CLINICAL
OUTCOMES DUE TO USE OF PHARMACEUTICALS EXPOSED TO EXTREME T/H
RANGES.
2. PROCEDURES. THE FOLLOWING PROCEDURES APPLY TO ALL
PHARMACEUTICALS THAT HAVE A PRESCRIBED T/H RANGE ANNOTATED ON THE
MANUFACTURER LABEL.
A. USMC UNITS WAREHOUSING PHARMACEUTICALS MUST ESTABLISH A T/H
MONITORING AND QUALITY CONTROL PROGRAM TO ENSURE PHARMACEUTICALS
ARE STORED AND MAINTAINED WITHIN SPECIFIED MANUFACTURER
GUIDELINES.
B. MONITORING MAY BE CONTINUOUS OR PERIODIC. IF PERIODIC,
READINGS MUST BE DONE AT LEAST TWICE DURING EACH 24-HOUR PERIOD.
TIMES AND LOCATION FOR THE READINGS WILL BE RANDOM. ALL READINGS
MUST BE DOCUMENTED AND MADE AVAILABLE FOR INSPECTION.
C. CONTINUOUS MONITORING THROUGH USE OF COMMERCIAL
MONITORS/ALARMS IS RECOMMENDED. MONITORS MAY BE OF THE TYPE THAT
TRIGGERS AN ALARM WHENEVER A SINGLE EVENT OR CUMULATIVE OUT OF
RANGE PARAMETERS ARE MET; OR, A MONITOR, THAT TRIGGERS AN
ALARM, AS WELL AS, PROVIDES SPECIFIC DETAILED TIME/TEMPERATURE
HISTORY. CONTACT YOUR LOCAL MAINTENANCE ENGINEER OR PUBLIC WORKS
CENTER FOR INFORMATION ON WAREHOUSE T/H MONITORING.
D. ANY PHARMACEUTICAL THAT IS FOUND TO HAVE BEEN EXPOSED TO T/H
CONDITIONS OUTSIDE THE PRESCRIBED MANUFACTURER GUIDELINES FOR
MORE THAN 72 CONSECUTIVE HOURS WILL BE CONSIDERED UNSERVICEABLE
STOCK AND NOT AVAILABLE FOR ISSUE.
E. ANY SPECIFIC PHARMACEUTICAL LOT NUMBER, CLASSIFIED AS
UNSERVICEABLE DUE TO CUMULATIVE T/H EXPOSURE OUTSIDE MANUFACTURER
GUIDELINES, THAT HAS AN AGGREGATE VALUE OF MORE THAN ONE THOUSAND
DOLLARS MAY BE SUBMITTED AS A CANDIDATE FOR FDA TESTING IN
ACCORDANCE WITH REF C. MATERIEL NOT SUBMITTED FOR SHELF LIFE
EXTENSION PROGRAM WILL BE DISPOSED OF IN ACCORDANCE WITH REFS D,
E, AND LOCAL APPLICABLE DIRECTIVES.
3. ACTION. MARINE CORPS UNITS STORING PHARMACEUTICALS, MUST
DEVELOP AND IMPLEMENT APPROPRIATE PROCEDURES AND SYSTEMS TO SUPPORT
PRESERVATIVE MEASURES OF PHARMACEUTICALS IN STORAGE. THESE
PROCEDURES MUST BE IN PLACE BY 31 DEC 01.//
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