ARCOS Registrant Handbook

5.11 QUANTITY

5.11.1 Definition: Quantity

The quantity field is a 6-digit (manual) or 8-digit (automated) numeric field containing the number of packages, weight, or volume being reported.

5.11.2 Specifications: Quantity

5.11.3 Discussion: Quantity

5.11.3.1 Converting Fractional (Decimal) Quantities

All quantities must be reported in whole numbers that have neither been truncated nor rounded. To report a fractional quantity, convert the amount to units that do not require fractions. For example, to report a bulk quantity of 417.29 grams, the quantity must be converted to milligrams prior to being reported (i.e., 417.29 grams would be reported as a quantity of "417290" with a Unit Code of 2 which indicates milligrams. The following examples illustrate the correct coding of fractional quantities for both automated and manual reports:

Automated Report (numbers in parenthesis indicate data field numbers)

Manual Report (numbers in parenthesis indicate data field numbers)

5.11.3.2 Coding the Quantity Field

Exhibit 5.13: Quantity Field Entries, illustrates quantity field coding. 

Exhibit 5.13: Quantity Field Entries

Appendix 4, Use of Quantity, Unit, and Strength Fields, contains additional examples of the relationships between various types of products (e.g., bulk raw powder, bulk dosage units, trade packages) and the quantity, unit, and strength fields in the ARCOS transaction record.

5.11.3.3 Reporting Bulk Raw Material

The unit (Field 6) and strength (Field 11 automated, Field 10 manual) fields must always be completed when reporting a Bulk Raw Material (package code = **) by weight or volume. See example below:

Example:

A manufacturer reports the synthesis (production) of a Schedule II bulk drug in raw powder form, 100 % pure. This product is chemically identified as Ecgonine Hydrochloride, molecular weight 221.69, NDC designation 00179-0062-**. The manufacturer sells 3,365.45gms of the product to another ARCOS registrant on January 21, 1997 under DEA order form number 940590027. The following example illustrates the coding for this transaction.

Automated Report: (numbers in parenthesis indicate data field numbers)

Note: Reported as milligrams

Manual Report: (numbers in parenthesis indicate data field numbers)

5.11.3.4 Reporting Bulk Dosage Form Material

When a finished bulk item (e.g., drum of capsules or tablets) is reported, it is typically assigned a double asterisk (**) for its NDC package code. The quantity field contains the total number of bulk dosage units being reported. See example below:

Example:

Manufacturer reports the production of large quantities of capsules, each capsule contains 10mg of Schedule II d-amphetamine hydrochloride, molecular weight 171.67, NDC designation 00023-0124-**. Manufacturer sells 865,400 capsules to another ARCOS Registrant on May 22, 1997 under DEA order form number 940079038. The coding example for this transaction is illustrated below.

Automated Report (numbers in parenthesis indicate data field numbers)

 Manual Report (numbers in parenthesis indicate data field numbers)

5.12 UNIT CODE

5.12.1 Definition: Unit Code

The unit code is a single-character, alphanumeric field used in conjunction with the quantity and strength fields to specify, by weight or volume, the amount of an NDC product being reported.

5.12.2 Specifications: Unit Code

5.12.3 Weight and Volume Unit Codes

The unit code field must be completed for all transactions reported by weight or volume by entering one of the following unit codes:

1 = micrograms
2 = milligrams
3 = grams
4 = kilograms
5 = milliliters
6 = liters

5.12.4 Optional Unit Codes

Transaction records reporting NDCs that consist of complete package or dosage units do not require a unit code. However, the following optional unit codes may be used to report dozens or thousands of packages or dosage units.

1. D = Dozens:
   
   "D" indicates that the entry in the quantity field (Field 5) represents dozens of packages or dozens of dosage units.
   
   
2. K = Thousands:
   
   "K" indicates that the entry in the quantity field (Field 5) represents thousands of packages or thousands of dosage units.

Example:

A sale of 10,000 units can be reported with a number 10 in the quantity field (Field 5) and a "K" in the unit code field (Field 6) as follows:

Automated Report: (numbers in parenthesis indicate data field numbers)

Manual Report: (numbers in parenthesis indicate data field numbers)

Appendix 4, Use of Quantity, Unit, and Strength Fields, contains additional examples of how to use quantity, unit code, and strength fields to report transactions involving NDC products in various forms, (e.g., bulk raw powder, bulk dosage units, trade packages).

5.13 ASSOCIATE REGISTRANT NUMBER

5.13.1 Definition: Associate Registrant Number

The associate registrant number is a 9-character field identifying the customer or supplier with which the transaction took place. For a sale enter the DEA registration number of the customer. For a purchase enter the DEA registration number of the supplier. Note: This field is labeled "Associate Registration Number" on DEA Form 333.

5.13.2 Specifications: Associate Registrant Number

5.13.3 Discussion: Associate Registrant Number

The associate registrant number is required for each transaction that increases or decreases the ARCOS registrant’s inventory. The reporting registrant number and the associate registrant number cannot be the same. The associate registrant number field is not completed when reporting the following transaction codes:

5.13.3.1 Transfers to Exempt Organizations

Organizations which are exempt from registration with DEA under the Controlled Substances Act may acquire products containing controlled substances from an ARCOS registrant. When an ARCOS registrant provides an exempt organization with such a product, the registrant reports this transaction by entering one of the codes listed in Exhibit 5.14: Exempt Organization Codes, in the associate registrant number field, Field 7. All entries must be left justified and in all capital (upper case) letters. Any remaining positions or columns must be blank. 

Exhibit 5.14: Exempt Organization Codes

5.13.3.2 Transfers Within a Firm

The transfer of a controlled substance from one DEA registration to another within the same firm, must be treated as a normal sale (transaction code S) and purchase (transaction code P). For example, when a transfer from a manufacturer’s inventory to a distributor’s inventory takes place, two transactions are reported:

1. A sale (transaction code S) is reported under the manufacturing registration number. The distributor’s DEA registration number is entered into the associate registrant number field (Field 7). 
2. A purchase (transaction code P) is reported under the distributor’s registration number. The manufacturer’s DEA registration number is entered into the associate registrant number field (Field 7).

5.13.3.3 Destruction of Reportable Items

Enter the registration number of the DEA area office in the associate registrant number field when reporting all destructions of controlled substances (transaction code Y. If necessary, contact the DEA area office or the Data Systems Unit (ARCOS) to obtain the DEA registration number. DEA Form 41, Registrants Inventory of Drugs Surrendered, must be completed and filed with the local DEA area office. Exhibit 5.6: DEA Form 41, contains a sample form.

5.14 DEA ORDER FORM NUMBER

5.14.1 Definition: Order Form Number

The DEA order form number field is a 9-character field in which the number of the order form (DEA Form 222) is entered. This field is used only when Schedules I and II controlled substances are transferred. An order form is illustrated in Exhibit 5.15: DEA Form 222.

5.14.2 Specifications: Order Form Number

Exhibit 5.15: DEA Form 222

5.14.3 Discussion: Order Form Number

An order form, DEA Form 222, is required, pursuant to 21 CFR 1305, for transfers of Schedules I and II controlled substances, but an order form is not required for Schedule III narcotics. Leave the DEA order form number field blank when reporting Schedule 3 narcotics. Copy 2 of each DEA order form must be forwarded to the supplier’s local DEA area office. Do not mail any copies of DEA Form 222 to DEA (ARCOS).

5.14.3.1 Manufacturer Recall

When a manufacturer recalls a reportable product, the transaction must be reported as a purchase (transaction code P). Those firms returning the product, that are alsoARCOS registrants, report a sale (transaction code S). When a schedule I or II controlled substance is recalled, DEA, Office of Diversion Control, may grant a limited exemption to the requirement for order forms. When such an exemption has been granted, the DEA order form number field (Field 8), must be completed with the word "RECALL" in all capital letters, left justified. The remainder of the field must contain blank spaces.

5.15 TRANSACTION DATE

5.15.1 Definition: Transaction Date

The transaction date is the actual date on which a reportable activity occurred. Exceptions are covered in Section 5.15.4, Discussion.

5.15.2 Specifications: Transaction Date

5.15.3 Transaction Date Formats

Automated Format: MMDDYY (month, day, year)

 Manual Format: YMMDD (year, month, day)

5.15.4 Discussion: Transaction Date

A transaction date must be entered for all transactions. The transaction date mustbe the actual date on which the activity occurs. Except for manufacturing codes and delete, late, and adjustment transactions, the date of a transaction must never fall outside of the reporting period for the report being submitted.

Examples:

1. A transaction record with a June transaction date submitted with the July report is rejected unless it is a delete, late, or adjustment transaction (action indicator "D", "A", or "I").
   
2. Manufacturing activities associated with transaction codes M, K, U, N, W, L, Q, and J are reported as of the end of a quarter or the end of each year, even though these activities may actually have occurred on other dates during the year.

When using the duplicate sign (i.e. "=") to repeat a transaction date within a manual report, fields 11, 12 and 13 must be considered one field. In other words, the entire date mustbe the same when using the duplication sign. See Exhibit 5.2: Using the Duplicate Sign, Single Reporter or Exhibit 5.3: Using the Duplicate Sign, Central Reporter.

5.16 CORRECTION TRANSACTION

5.16.1 Definition: Correction Transaction

A Correction Transaction corrects a transaction that has been rejected by the data validation procedures. Rejected transaction records are listed in the Daily Transaction Processing Error Report.

5.16.2 Specifications: Correction Number (Formerly Lot Number)

5.16.3 Discussion: Correction Number

Each Correction Transaction is identified by a unique, sequential correction number. The system uses this number when reprocessing the corrected transaction record. The correction number is listed on the error report and must be entered into the correction number field. The Correction Transaction is a component of ARCOS error processing. Section 7.5, Correcting Transaction Records, contains a full discussion of error processing including specific instructions for using the Correction Transaction.

5.17 STRENGTH

5.17.1 Definition: Strength

The strength field is used to report three different kinds of data: (1) the purity of a bulk raw material (2) the fractional portion of a standard NDC package size or (3) the percentage by which a package exceeds a standard NDC package size.

5.17.2 Specifications: Strength

5.17.3 Discussion: Strength

5.17.3.1 Strength Field: Bulk Raw Materials

The strength field must be completed when reporting a bulk raw material. All bulk raw materials and their level of purity are initially entered into the ARCOS drug ingredient dictionary. A strength field entry of 1000 (i.e. 100.0% purity) in a transaction involving a bulk raw controlled substance product indicates that the purity of the product being reported is the same as the corresponding NDC bulk raw material listed in the ARCOS drug ingredient dictionary. The strength field is required when reporting bulk raw materials. Any entry different from 1000 in this field indicates that the material being reported has a different purity than the bulk NDC listed in the ARCOS drug ingredient dictionary.

Example 1:

An NDC for a bulk raw material containing controlled substance with 90% purity is listed in the drug ingredient dictionary. The manufacturer sells a quantity of this material, unaltered, to a distributor, i.e. the manufacturer sells a powder containing 90% of a reportable controlled substance. Both manufacturer and distributor report this transaction (a sale for the manufacturer and a purchase for the distributor) with an entry of 1000 in the strength field, indicating that the purity of the product reported is equal to that of the product listed in the drug ingredient dictionary.

Example 2:

The same manufacturer as above (example 1) makes a batch of the same controlled substance mentioned above, but this time the purity of the batch is only 81%. The manufacturer wishes to sell some of this 81% pure controlled substance product using the NDC that is based on 90% purity. In order to do this, the manufacturer enters 0900 in the strength field, indicating that the purity of the material being reported is 90.0% of the 90% purity of the bulk NDC listed in the drug ingredient dictionary (.900 x .90 = .81).

5.17.3.2 Strength Field: Partial Packages

A partial package is an NDC package that has been opened and contains less than its original contents. To report a transaction with a partial package, enter the entire NDC in the NDC field (Field 4). Enter 1 with the correct number of leading zeroes in the quantity field (Field 5). In the strength field, enter the number of thousandths of the original contents of the NDC package that are being reported.

Example:

An NDC represents a bottle containing 100 LAAM hydrochloride tablets. An ARCOS registrant has an opened bottle of this NDC with 90 tablets remaining, 90% of the original package contents. To report this partial package, enter 1 with leading zeroes in the quantity field (Field 5) and "0900" in the strength field (Field 11 automated, Field 10 manual). The entry "0900" in the strength field indicates 90.0%. The decimal point in this percentage is implied, it is not to be coded. The following illustrations depict the correct automated and manual coding for reporting this example.

ARCOS Automated Report: (numbers in parenthesis indicate data field numbers)

ARCOS Manual Report: (numbers in parenthesis indicate data field numbers)

5.17.3.3 Strength Field: Combining Partial Packages

Two or more partial packages with the identical NDC may be reported as separate transactions or added together and reported as a single transaction, even when their combined contents are more than one complete package. The example below illustrates reporting two partial packages as a single transaction.

Example:

The standard NDC package size of Amytal tablets contains 100 tablets. An ARCOS Registrant needs to report two packages, each package containing less than 100 tablets. One package contains 90 Amytal tablets, while the other contains 25 Amytal tablets. The combined total of these two partial packages amounts to 115 tablets. This amount equals 115 percent of the standard package size.

To report 115 tablets as a single transaction, code a quantity of "1" in the quantity field (Field 5) and 1150 (115.0 percent of a full package) in the strength Field (Field 11 automated, Field 10 manual). Again, there is an implied decimal point between the two right-most positions in the strength Field.

ARCOS Automated Report: (numbers in parenthesis indicate data field numbers)

ARCOS Manual Report: (numbers in parenthesis indicate data field numbers)

Refer to Appendix 4, Use of Quantity, Unit, and Strength Fields, for additional illustrations of ARCOS reporting relationships between various types of NDC products (i.e., bulk raw powder, bulk dosage units, trade packages) and the (a) quantity, (b) unit code, and (c) strength data fields in the ARCOS transaction record.

5.18 TRANSACTION IDENTIFIER

5.18.1 Definition: Transaction Identifier

The transaction identifier is a sequential number assigned by the reporting registrant to each transaction record.

5.18.2 Specifications: Transaction Identifier

5.18.3 Discussion: Transaction Identifier

The transaction identifier field for transaction records submitted by central reporters may use one of two configurations:

1. Continuous Sequence:
   
   Transaction records may be numbered in a continuous sequence.
   
   
2. Separate Sequences
   
   Transaction records for each reporting registrant may be numbered in separate sequences.

Example: Continuous Sequence

A central reporter submits a report for itself and two subsidiaries containing a total of 150 transactions. These records may be numbered sequentially and continuously "1" through "150."

Example: Separate Sequences

A central reporter submits a report for itself and three subsidiaries containing a total of 400 transactions. These records may be numbered "1" to "125" for the central reporters own registration number, "1" to "50" for the first subsidiary, "1" to "200" for the second subsidiary and "1" to "25" for the third subsidiary.

5.19 DOCUMENT IDENTIFIER

5.19.1 Definition: Document Identifier

The document identifier is used to distinguish reports submitted on magnetic media (i.e., diskette or tape) from reports submitted on DEA Form 333 coding sheets. The document identifier appears only in automated transaction records.

5.19.2 Specifications: Document Identifier 

5.19.3 Discussion: Document Identifier

No additional discussion.

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