ARCOS
> ARCOS Error Report Notices
ARCOS Error Report Notices are provided as an end of report 'Trailer'
on each Daily Transaction Processing Report generated by the ARCOS-2
system, in response to ARCOS registrants who file ARCOS reports with DEA.
These Reports are generated each time an ARCOS report is processed by the
ARCOS-2 system. The 'Trailer' in each report includes information for
manufacturers and distributors from the ARCOS Unit regarding the ARCOS
reporting process. The current notices include topics outlined below.
July 1, 2008
*** COMMERCIAL MAILING ADDRESS CHANGE (DEA HEADQUARTERS).
EFFECTIVE JULY 1, 2008, ALL PARCELS/MAIL SENT BY ARCOS PARTICIPANTS TO DEA
HEADQUARTERS VIA COMMERCIAL CARRIER SUCH AS FEDERAL EXPRESS (FEDEX), UNITED PARCEL SERVICE (UPS), SPECIAL MESSENGERS, DHL, ETC. SHOULD BE
ADDRESSED AS FOLLOWS:
DEA HEADQUARTERS
ATTN: ARCOS UNIT
8701 MORRISSETTE DRIVE
SPRINGFIELD, VA 22152
ARCOS REGISTRANTS USING THE U.S. POSTAL SERVICE FOR DELIVERY OF ARCOS
TRANSACTION REPORTING MEDIA, OR OTHER DOCUMENTS, MUST USE THE FOLLOWING ADDRESS:
DEA HEADQUARTERS
ATTN: ARCOS UNIT
P.O. BOX 2520
SPRINGFIELD, VA 22152-2520
JANUARY 3, 2007
** SPECIAL PROCEDURES FOR MAILING ARCOS REPORTS TO DEA.
UNTIL FURTHER NOTICE, TO PREVENT DAMAGE TO DISKETTES AND CDs THAT MAY OCCUR FROM DECONTAMINATION PROCEDURES, THE ARCOS UNIT IS REQUESTING THAT ALL ARCOS REPORTS BE SUBMITTED VIA CERTIFIED MAIL OR THROUGH AN OVERNIGHT DELIVERY SERVICE (FEDEX, UPS, EXPRESS MAIL, ETC.) TO THE FOLLOWING ADDRESS:
DRUG ENFORCEMENT ADMINISTRATION
ATTN: ARCOS UNIT
2401 JEFFERSON-DAVIS HIGHWAY
ALEXANDRIA, VA 22301
June 15, 2005
- ARCOS EDI PARTICIPANTS MUST CONTINUE USING THE STANDARD ARCOS
80 CHARACTER RECORD FORMAT AND CONTROL RECORD WHEN SUBMITTING ARCOS
REPORTS VIA THE ARCOS EDI SYSTEM FOR SUBMISSION OF MONTHLY/QUARTERLY
ARCOS REPORTS, UNTIL FURTHER NOTICE. ARCOS REPORTS RECEIVED IN ANY
OTHER FORMAT WILL BE REJECTED BY THE ARCOS SYSTEM. ADDITIONALLY, ARCOS
REPORTS MUST INCLUDE ONLY THE MANUFACTURE, DISTRIBUTION, ACQUISITION
AND INVENTORIES OF SCHEDULES I AND II MATERIALS, NARCOTIC AND GAMMA-HYDROXYBUTYRIC
ACID (GHB) MATERIALS IN SCHEDULE III, AND SPECIFIC ACTIVITIES
INVOLVING THE MANUFACTURE OF SELECTED SCHEDULES III AND IV
PSYCHOTROPIC MATERIALS (REF. TITLE 21, CODE OF FEDERAL REGULATIONS
(21CFR) SECTION
1304.33).
- CONTROLLED SUBSTANCE ORDERING SYSTEM (CSOS) PARTICIPANTS MUST SUBMIT
THEIR REPORTS USING THE 105 CHARACTER RECORD FORMAT WHICH IS DESCRIBED
IN THE CSOS WEBSITE @ HTTP://WWW.DEAECOM.GOV PLEASE ADDRESS
QUESTIONS REGARDING CSOS REPORTING REQUIREMENTS TO THE CSOS SUPPORT
STAFF AT 1-877-DEA-ECOM (1-877-332-3266).
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MARCH 24, 2005
-
CIII GAMMA-HYDROXYBUTYRIC ACID (GHB) NOW ARCOS REPORTABLE: ON
JANUARY 4, 2005, THE DRUG ENFORCEMENT ADMINISTRATION ISSUED A FINAL
RULE (FEDERAL REGISTER:
JANUARY 4, 2005, VOL. 70, NO. 2) AMENDING ITS REGULATIONS TO
INCLUDE SCHEDULE III GHB DRUG PRODUCTS AS CONTROLLED SUBSTANCES THAT
MUST BE REPORTED BY MANUFACTURERS AND DISTRIBUTORS UNDER THE
AUTOMATION OF REPORTS AND CONSOLIDATED ORDERS SYSTEM (ARCOS). THIS
FINAL ACTION, WITH AN EFFECTIVE DATE OF FEBRUARY 3, 2005, IMPOSES THE
REGULATORY REPORTING REQUIREMENTS OF TITLE 21, CODE OF FEDERAL
REGULATIONS (21CFR) SECTION 1304.33 (AND OTHERS) ON THOSE PERSONS WHO
HANDLE CIII GHB DRUG PRODUCTS. A FULL DISCUSSION OF THIS RULE CHANGE
IS AVAILABLE ON THE DEA OFFICE OF DIVERSION CONTROL'S WEB SITE AT
WWW.DEADIVERSON.USDOJ.GOV AND CAN BE ACCESSED BY CLICKING THE 'FEDERAL
REGISTER NOTICES', 'RULES' 2005 BUTTONS.
-
SUBMISSION OF SCHEDULE CHANGE INVENTORY (TRANSACTION CODE '1') TO
ARCOS: AS A RESULT OF THE NEW REPORTING REQUIREMENTS FOR GHB,
MANUFACTURERS AND DISTRIBUTORS OF DRUG PRODUCTS CONTAINING GHB MUST
REPORT TO ARCOS ALL ON HAND STOCKS OF GHB USING A TRANSACTION CODE '1'
(SCHEDULE CHANGE INVENTORY). TRANSACTION CODE '1' WILL ESTABLISH
EXISTING STOCKS OF GHB INVENTORY IN ARCOS. REGISTRANTS MUST PERFORM AN
INVENTORY OF GHB STOCKS ON OR BEFORE MAY 15, 2005. TRANSACTION CODE
'1' SUBMISSIONS ARE DUE WITH THE MAY, OR SECOND QUARTER, 2005 ARCOS
REPORTS. MANUFACTURERS AND DISTRIBUTORS MUST ALSO REPORT ALL
APPLICABLE ARCOS ACTIVITY INVOLVING GHB IN ACCORDANCE WITH TITLE
21, CODE OF FEDERAL REGULATIONS (21CFR) SECTION 1304.33.
-
SUBMISSION OF DRUG LABELS: THE ARCOS UNIT REQUESTS THAT
MANUFACTURERS/LABELERS OF GHB DRUG PRODUCTS SUBMIT COPIES OF
COMMERCIAL DRUG LABELS OR LABELING INFORMATION TO THE ARCOS UNIT FOR
INCORPORATION INTO THE ARCOS NATIONAL DRUG CODE (NDC) DICTIONARY.
LABELS MUST BE PROVIDED TO THE ARCOS UNIT PRIOR TO THE USE OF A GHB
PRODUCT NDC IN AN ARCOS TRANSACTION REPORT.
PLEASE CONTACT THE ARCOS UNIT AT (202)307-8600, for additional
INFORMATION.
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FEBRUARY 2, 2004
SUBMISSION OF THEFT AND LOSS REPORTS TO ARCOS.
REMINDER - IN ACCORDANCE WITH THE CODE OF FEDERAL REGULATIONS, TITLE 21
(21 CFR), SECTION 1304, MANUFACTURERS AND DISTRIBUTORS WHO PARTICIPATE IN
THE ARCOS PROGRAM ARE REQUIRED TO REPORT CONTROLLED SUBSTANCES STOLEN FROM
PREMISES USING TRANSACTION CODE "T". IN-TRANSIT THEFTS OR LOSSES
OF CONTROLLED SUBSTANCES REQUIRE SUBMISSION OF TRANSACTION CODE
"X" (REF. ALSO 21CFR SECTION 1304). TRANSACTION CODES
"T" AND "X" MUST BE INCLUDED IN ROUTINE ARCOS
TRANSACTION REPORTING IN ADDITION TO COMPLETION AND FILING OF THE DEA
FORM-106, "REPORT OF THEFT OR LOSS OF CONTROLLED SUBSTANCES",
WITH THE LOCAL DEA OFFICE. SEE THE "ARCOS REGISTRANT HANDBOOK",
SECTIONS 5.7 AND 5.8 FOR ADDITIONAL DISCUSSION OF THESE TRANSACTION CODES.
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NOVEMBER 16, 2000
1. CORRECT USE OF THE QUANTITY AND UNIT FIELDS FOR BULK PRODUCTS:
MANUFACTURERS AND DISTRIBUTORS ARE INCORRECTLY REPORTING ARCOS
TRANSACTIONS INVOLVING THOSE NDC PRODUCTS CONTAINING A DOUBLE ASTERISK
(I.E.,'**') IN THE PACKAGE CODE PORTION OF THE NATIONAL DRUG CODE (NDC)
NUMBER. THE ERRORS USUALLY OCCUR IN MISCODING THE UNIT AND STRENGTH FIELDS
OF THE ARCOS TRANSACTION. SPECIFICALLY, THESE NDC PRODUCTS REPRESENT FOUR
DISTINCT TYPES OF PRODUCTS AS FOLLOWS:
A.) BULK SINGLE DOSAGE UNIT SOLID FORMULATIONS (I.E., CONCENTRATION PER
TABLET, CONCENTRATION PER CAPSULE, CONCENTRATION PER AMPULE, CONCENTRATION
PER SUPPOSITORY OR ANY OTHER TYPE OF BULK SINGLE DOSAGE UNIT SOLID
FORMULATION: FOR ALL ARCOS ACQUISITION, DISPOSITION, MANUFACTURING AND
INVENTORY TRANSACTIONS, (EXCEPT TRANSACTION CODES 7, 8, AND F), WHICH
INVOLVE THE REPORTING OF BULK SINGLE DOSAGE UNIT SOLID FORMULATIONS, ENTER
EITHER A 'BLANK', 'D' FOR DOZENS OR 'K' FOR THOUSANDS IN THE UNIT FIELD
AND A 'BLANK' IN THE STRENGTH FIELD. ANY OTHER DESIGNATION IN THE UNIT
FIELD WILL GENERATE AN ERROR REPORT.
B.) BULK SINGLE DOSAGE UNIT LIQUID FORMULATIONS (I.E., CONCENTRATION
PER MILLILITER): FOR ALL ARCOS ACQUISITION, DISPOSITION, MANUFACTURING AND
INVENTORY TRANSACTIONS, (EXCEPT TRANSACTION CODES 7,8 AND F), WHICH
INVOLVE THE REPORTING OF BULK SINGLE DOSAGE UNIT LIQUID FORMULATIONS,
ENTER EITHER '5' FOR MILLILITERS, OR '6' FOR LITERS IN THE UNIT FIELD AND
A 'BLANK' IN THE STRENGTH FIELD. ANY OTHER DESIGNATION IN THE UNIT FIELD,
PARTICULARLY WEIGHT DESIGNATION CODES (I.E., '1' FOR MICROGRAMS, '2' FOR
MILLIGRAMS, '3' FOR GRAMS AND '4' FOR KILOGRAMS), WILL GENERATE AN ERROR
REPORT.
* NOTE THAT THE CURRENT ARCOS-2 SYSTEM IS NOW CAPABLE OF
DISTINGUISHING BETWEEN BULK SINGLE DOSAGE UNIT SOLID FORMULATIONS AND
BULK SINGLE DOSAGE UNIT LIQUID FORMULATIONS.
C.) BULK RAW POWDERS: FOR ALL ARCOS ACQUISITION, DISPOSITION,
MANUFACTURING AND INVENTORY TRANSACTIONS, (EXCEPT TRANSACTION CODES 7, 8,
AND F), WHICH INVOLVE THE REPORTING OF BULK RAW POWDERS ENTER ONLY A
WEIGHT DESIGNATION CODE (I.E., '1' FOR MICROGRAMS, '2' FOR MILLIGRAMS, '3'
FOR GRAMS AND '4' FOR KILOGRAMS) IN THE UNIT FIELD AND '0001' TO '1050' IN
THE STRENGTH FIELD. ANY OTHER DESIGNATION IN THE UNIT AND STRENGTH FIELDS
WILL GENERATE AN ERROR REPORT.
D.) BULK RAW LIQUIDS: FOR ALL ARCOS ACQUISITION, DISPOSITION,
MANUFACTURING AND INVENTORY TRANSACTIONS, (EXCEPT TRANSACTION CODES 7, 8,
AND F), THAT INVOLVE THE REPORTING OF BULK RAW LIQUIDS ENTER ONLY A LIQUID
DESIGNATION CODE (I.E., '5' FOR MILLILITERS OR '6' FOR LITERS IN THE UNIT
FIELD) AND '0001' TO '1000' IN THE STRENGTH FIELD). ANY OTHER DESIGNATION
IN THE UNIT AND STRENGTH FIELDS WILL GENERATE AN ERROR REPORT.
ARCOS (202) 307-8600
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