a. Field Number:	2
b. Field Name:	transaction code
c. Field Length:	1 Character
d. Position/Column:	10
e. Type:	Alphanumeric
f. Special Rules:
1. Only Specific Codes Permitted
2. Mandatory Entry
3. Use Capital Letters for Alphabetic Data

5.4.3 Discussion: Transaction Code

Manufacturers and distributors are responsible for reporting all ARCOS activities and inventories. The transaction code field identifies the reporting registrant’s controlled substance acquisitions, dispositions, inventories, and miscellaneous transactions. The transaction codes listed below have been grouped into four categories for ease in selecting the correct code under which to report a specific business or manufacturing activity. These four categories are: inventory, acquisition, disposition, and miscellaneous. They are discussed in detail in Section 5.5 through 5.7. See Appendix 1, ARCOS Transaction Matrix: Automated Reports or Appendix 2, ARCOS Transaction Matrix: Manual Reports, to determine which fields must be completed for a specific transaction code.

transaction code 1: Schedule Change Inventory
transaction code 3: Year-End Inventory
transaction code 4: Year-End In-Process Inventory (manufacturers only)
transaction code 5: Special Inventory
transaction code 8: No Year-End Inventory

transaction code P: Purchase or Receipt
transaction code R: Return
transaction code V: Unsolicited Return
transaction code G: Government Supplied
transaction code W: Recovered Waste (manufacturers only)
transaction code M: Manufactured (manufacturers only)
transaction code L: Reversing (manufacturers only)
transaction code J: Return of Sample to Inventory (manufacturers only)

Disposition Transaction Codes (Decreases to Inventory)

transaction code S: Sale, Disposition, or Transfer
transaction code Y: Destroyed
transaction code T: Theft
transaction code Z: Receipt by Government (seizures, samples, etc.)
transaction code N: Nonrecoverable Waste (manufacturers only)
transaction code U: Used in Production (manufacturers only)
transaction code Q: Sampling (manufacturers only)
transaction code K: Used in Preparations (manufacturers only)

transaction code 7: No ARCOS Activity for the Current Reporting Period
transaction code F: Reorder DEA Form 333
transaction code X: Lost-in-Transit

5.5 INVENTORY TRANSACTION CODES

Transaction code 1, Schedule Change Inventory; transaction code 3, Year-End Physical Inventory; transaction code 4, In-Process Inventory; and transaction code 5, Special Inventory are used when reporting inventory data to DEA (ARCOS).

All ARCOS registrants are required to take a physical, year-end inventory (YEI). This inventory must reflect the actual amount of each reportable controlled substance on the registrant’s premises as of the close of business on December 31st of each year. This is the only valid date which is accepted for transaction code 3. If the year-end inventory report is not dated December 31, the transaction record is rejected. If year-end inventory transactions are included in the December or fourth quarter report, the reporting registrant must write "YEI INCLUDED" in the "Notes" block of the bar code label. This indicates that the December or fourth quarter report also contains the year-end inventory report and will prevent the registrant from being placed in a delinquent reporting status.

5.5.3 Code 4: Year-end In-process Inventory

On December 31st of each year, a manufacturer may have some quantities of controlled substances that are still in the manufacturing production chain (i.e., not in a bulk or finished dosage form). The amount of controlled substance at this stage of the production chain is termed an "In-process Inventory" quantity. Year-end In-process Inventory is reported using transaction code 4. The Year-end In-process Inventory is to be taken at the close of business on December 31st of the reporting year. This is the only date which will be accepted for transaction code 4. See Section 6, Manufacturing Activities, for examples of In-process Inventory reporting.

5.5.4 Code 5: Special Inventory

A Special Inventory is any inventory other than a Year-end, Year-end In-process, or Schedule Change Inventory being taken at the direction of DEA. Report a Special Inventory using transaction code 5.

Transaction code 8 is used to report zero (0) year-end inventory. If, at the close of business on December 31st, an ARCOS registrant has no (i.e., zero) physical inventory for all the reportable controlled substances that it handles, the firm must report this lack of physical inventory to DEA (ARCOS). It is not necessary to report the lack of inventory for each reportable controlled substance that the firm has handled through the year. A single transaction code 8 is sufficient. The "no-year-end inventory" report will prevent DEA (ARCOS) from placing the registrant in a delinquent reporting status. transaction code 8 requires the following fields:

• reporting registrant number 

• transaction code 8  

• transaction date (December 31st of each year)  

• transaction Identifier

5.6 ACQUISITION TRANSACTION CODES

An ARCOS registrant can acquire controlled substances by buying them, by having previously sold controlled substances returned, or by receiving them from the government. If the ARCOS registrant is a manufacturer, the registrant can acquire controlled substances by four additional means: (1) manufacturing them, (2) recovering them from manufacturing waste, (3) having samples of controlled substances returned, or (4) by decomposing a substance into its component substances; one of which is a controlled substance. Acquisitions of controlled substances, irrespective of the manner in which they are acquired, increase the ARCOS registrant’s inventory.

5.6.1 Code P: Purchase or Other Receipt

Transaction code P, purchase or other receipt, is used to report controlled substance acquisitions under three different scenarios:

Transaction code R is used to report the receipt of returned controlled substances when the manufacturer or distributor requests their return. Returns reported under transaction code R do not necessarily involve a monetary transaction. Reportable controlled substances received by a supplier may include substances being returned for credit, salvage, re-work, or non-GMP (good manufacturing process) quality, as well as outdated or unused controlled substances.

5.6.3 Code V: Unsolicited Return

Transaction code V is used to report the receipt of an unsolicited return of a reportable controlled substance. An "unsolicited return" is a return that has not been requested by the manufacturer or distributor. The situations needing transaction code V are described below and summarized in Exhibit 5.5: Using Transaction Code V. 

1. Use transaction code V when a Schedule III narcotic shipment is received without any identifying markings indicating the name of the firm that shipped the drugs. In the associate registrant number field (Field 7), enter "UNKNOWN" in all capital letters and left justified.  

2. Use transaction code V when a Schedule I or II product is received without the prior issuance of an order form (U.S. Official Order Forms - Schedules I & II) DEA Form 222, and without any identifying markings indicating the name of the firm that shipped the product. In the associate registrant number field (Field 7), enter "UNKNOWN" in all capital letters and left justified. Additionally, a DEA Order Form Number must be acquired to cover the shipment. An "after-the-fact" DEA Order Form Number must be issued by the receiving firm using its own blank Order Form, after obtaining approval from the local DEA field office.

 Known Shipper

3. Use transaction code V when a Schedule III narcotic shipment is received without prior notification and the shipper is known. If the registrant decides to keep the shipment, the registrant must obtain the approval of the local DEA field office. The shipper’s DEA Registration Number is entered into the associate registrant number field (Field 7). 

4. Use transaction code V when a Schedule I or II shipment is received without the prior issuance of an order form, DEA Form 222, and the shipper is known. When such a shipment is received, the recipient firm must: (1) obtain the approval of the local DEA field office to issue an "after-the-fact" DEA order form number and (2) issue the DEA order form number using its own blank order form. The shipper’s DEA registration number is entered into the associate registrant number field (Field 7) and the order form number is entered in the DEA order form number field (Field 8).

5.6.4 Code G: Government Supplied

Transaction code G is used when the government supplies controlled substances or returns seized materials or samples to the reporting registrant. The registration number of the DEA or FDA divisional office is required in the associate registrant number field (Field 7). Contact your local DEA office to obtain the appropriate associate registrant number, if it is unknown.

5.6.5 Manufacturing Acquisition Codes

The following acquisition transaction codes are discussed in Section 6, Manufacturing Activities:

transaction code W Recovered Waste (Manufacturers Only)
transaction code M Manufactured (Manufacturers Only)
transaction code L Reversing (Manufacturers Only)
transaction code J Return of Sample to Inventory (Manufacturers Only)

5.7 DISPOSITION TRANSACTION CODES

Controlled substances can be sold, destroyed, taken by the government, or stolen (theft). Under the manufacturing process there are a number of additional ways to dispose of controlled substances: (1) non-recoverable waste, (2) used in manufacturing, (3) distribution of samples, and (4) used in preparations. Dispositions of controlled substances, irrespective of the manner in which they are disposed, decrease the ARCOS registrant’s inventory.

5.7.1 Code S: Sale, Disposition, or Transfer

Transaction code S is used when a controlled substance is physically transferred to another DEA registrant. This is not necessarily a monetary transaction. Samples to customers are included in this category. However, a sample that does not leave the ARCOS registrant’s premises is reported as a transaction code Q. See Section 6, Manufacturing Codes. The sale of reportable controlled substances reduces the manufacturer’s or distributor’s inventory.

In cases where a controlled substance is shipped directly from a supplier to an ARCOS registrant’s customer and is never physically on the registrant’s premises (e.g., the registrant only does the billing), the registrant must not report the transaction. The supplier and the recipient do the reporting.

5.7.2 Code Y: Destroyed

Transaction code Y is used for reporting authorized destructions of controlled substances. Enter the registration number of the local DEA area office in the associate registrant number field (Field 7). If necessary, contact the DEA area office or the Data Systems Unit (ARCOS) to obtain the DEA registration number. For all destructions,

DEA Form 41, Registrants Inventory of Drugs Surrendered, must be filed with the local DEA area office. Exhibit 5.6: DEA Form 41, contains a sample form. 

Exhibit 5.6: DEA Form 41

5.7.3 Code T: Theft

Transaction code T is used to report controlled substances stolen from your premises. This does not eliminate the requirement to prepare an official theft report, U.S. Department of Justice, Drug Enforcement Administration, Report of Theft or Loss of Controlled Substances, DEA Form 106. Contact your local DEA office for further details. See Section 5.8.3 Code X, for in-transit theft or loss. Exhibit 5.7: DEA Form 106, contains a sample theft report form. 

Exhibit 5.7: DEA Form 106

5.7.4 Code Z: Receipt by Government or Seizures

Transaction code Z is used to report the transfer (e.g., samples or seizure) of reportable controlled substances from a manufacturer or distributor to a government official. When a controlled substance is received by an agent of DEA or FDA, the DEA registration number of their Area Office must be entered in the associate registrant number field (Field 7). "OFFICER" is the entry in Field 7 for any other non-registered government official such as a customs officer; an agent of the Bureau of Alcohol, Tobacco, and Firearms; or state and local police officers. This entry must be in all capital letters and left justified within Field 7.

5.7.5 Manufacturing Disposition Codes

The following disposition transaction codes are discussed in Section 6, Manufacturing Activities:

transaction code N Nonrecoverable Waste (Manufacturers Only)
transaction code U Used in Production (Manufacturers Only)
transaction code Q Sampling (Manufacturers Only)
transaction code K Used In Preparations (Manufacturers Only)

5.8 MISCELLANEOUS TRANSACTION CODES

5.8.1 Code 7: No ARCOS Activity for the Current Reporting Period

Transaction code 7 is used to report the lack of controlled substance activity for the current reporting period. This lack of activity must be reported to DEA (ARCOS).  transaction code 7 is used when there has been no business activity for any and all controlled substances during the reporting period. It is not necessary to report no (i.e., zero) activity for each NDC product; a single transaction code 7 will suffice. Submitting a transaction code 7 will prevent DEA from placing the ARCOS Registrant in a delinquent reporting status. Transaction code 7 requires the following fields: 

• reporting registration number  

• transaction code 7 

• transaction date (last day of the reporting period) 

• transaction identifier

5.8.2 Code F: Reorder DEA Form 333

Transaction code F is used to re-order a supply of DEA Form 333. The quantity requested cannot exceed 500 sheets for any single re-order. When the quantity field (Field 5) is left blank 100 forms will be sent. Complete only the following fields:

5.8.3 Code X: Lost-in-Transit

Transaction code X is used by the seller to report the loss or theft of an in-transit shipment of a reportable controlled substance. It is reported in addition to the normal sales transaction (transaction code S). Transaction code X is an explanatory transaction code which does not affect an ARCOS registrant’s inventory. Enter the DEA registration number of the intended purchaser in the associate registrant number field (Field 7). If the product lost in transit was a Schedule I or II controlled substance the selling ARCOS registrant must file an official theft report, U.S. Department of Justice, Drug Enforcement Administration, Report of Theft or Loss of Controlled Substances, DEA Form 106, with the local DEA office. Exhibit 5.7: DEA Form 106, contains a sample theft report form. If the ARCOS registrant purchasing the product still wants it, this registrant must supply a new order form with a new DEA order form number to replace the original one.

5.9 ACTION INDICATOR (Formerly DELETE INDICATOR)

5.9.1 Definition: Action Indicator

The action indicator was formerly called the delete indicator. The name has been changed to reflect the fact that the function of this field has been expanded.

The action indicator is a single-character field which initiates three different ARCOS data base operations: (1) the deletion of a transaction record, (2) the revision (adjustment) of data in a transaction record, and (3) the insertion of a late transaction record. These three data base operations are components of ARCOS error processing. Section 7.5, Correcting Transaction Records, contains a full discussion of the error processing.

5.9.2 Specifications: Action Indicator

a. Field Number:	3
b. Field Name:	action indicator (Formerly delete indicator)
c. Field Length:	1 Character
d. Position/Column:	11
e. Type:	Alphabetic
f. Special Rules:
1. Code "D" to delete a transaction record
2. Code "A" to adjust (revise) data in a transaction record
3. Code "I" to insert (add) a late transaction record
4. Use only capital letters
5. Leave blank when unused

5.9.3 Discussion: Action Indicator

See Section 7.5, Correcting Transaction Records for additional action indicator instructions.

5.10 NATIONAL DRUG CODE (NDC)

5.10.1 Definition: NDC

The National Drug Code (NDC) used by ARCOS is an 11-character code that identifies controlled substance products. This code is divided into three segments: the labeler code, the product code, and the package size code. General specifications are presented in Section 5.10.2, Specifications: NDC, followed by detailed specifications for each segment.

5.10.2 Specifications: NDC

a. Field Number:	4
b. Field Name:	NDC Number
c. Field Length:	11 Characters
d. Position/Column:	12-22
e. Type:	Alphanumeric
f. Special Rules:
1. Always coded except for transaction codes 7, 8, and F.
2. Entries must be made in each segment (Labeler Code, Product Code, Package Size Code).
3. Do not use hyphens (-), slashes (/), or blanks.
4. Do not enter product’s name in lieu of the NDC.
5. Use capital letters for alphabetic data
6. See specific segment for additional special rules.

5.10.2.1 NDC Segment Specifications

Labeler Code

The National Drug Code Directory¹ defines a labeler as "...any firm that manufactures or distributes a drug product." The labeler code is assigned by the FDA.

a. Segment Name:			Labeler Code
b. Field Length:			5 Characters
c. Positions/Columns:			12-16
d. Type:			Alphanumeric
e. Special Rules:
1. Right justified.
2. Leading zeros must be entered to fill blank segment positions or columns.

Product Code

The National Drug Code Directory defines the product code as the segment that "identifies a specific strength, dosage form, and formulation for a particular labeler." The product code is assigned by the labeler. 

a. Segment Name:	Product Code
b. Field Length:	4 Characters
c. Positions/Columns:	17-20
d. Type:	Alphanumeric
e. Special Rules:
1. Right justified.
2. Leading zeros must be entered to fill blank segment positions or columns.

Package Size Code

The National Drug Code Directory defines package size code as the segment that "identifies trade package sizes." The package size code is assigned by the labeler.

a. Segment Name:	Package Size Code
b. Field Length:	2 Characters
c. Positions/Columns:	21-22
d. Type:	Alphanumeric or "**" for bulk finished (e.g., unpackaged bulk dosage units) or bulk raw material (e.g., powder or liquid)
e. Special Rules:
1. Right justified.
2. Leading zeros must be entered to fill blank segment positions or columns.

1. U.S Department of Health and Human Services, Food and Drug Administration, National Drug Code Directory, Vol I, June 1995.

5.10.2.2 Formatting Summary

Exhibit 5.8: NDC Formatting Summary, briefly describes the formatting specifications for the NDC. These specifications apply to controlled substance transactions reported on automated media as well as DEA Form 333 for the following products:

1. Bulk Raw Powder

2. Bulk Dosage Formulations

3. Bulk Solutions

4. Trade Packages

 

TYPE OF MATERIAL	Bulk raw powder; bulk dosage forms; bulk solutions
LABELER CODE POSITIONS or COLUMNS: 12-16	alphanumeric, right justified, fill blanks with leading zeros
PRODUCT CODE POSITIONS or COLUMNS: 17-20	alphanumeric, right justified, fill blanks with leading zeros
PACKAGE CODE POSITIONS or COLUMNS: 21-22	**
TYPE OF MATERIAL	Trade Packages
LABELER CODE POSITIONS or COLUMNS: 12-16	alphanumeric, right justified, fill blanks with leading zeros
PRODUCT CODE POSITIONS or COLUMNS: 17-20	alphanumeric, right justified, fill blanks with leading zeros
PACKAGE CODE POSITIONS or COLUMNS: 21-22	alphanumeric, right justified, fill blanks with leading zero

Exhibit 5.8: NDC Formatting Summary

5.10.3 NDC Coding Examples

The NDC configuration for ARCOS reporting is composed of a 5-character Labeler Code, a 4-character Product Code, and a 2-character Package Code. When the NDC for a product does not conform to the configuration required under ARCOS, the following changes must be made in the configuration:

1. A leading zero must be added to the Labeler Code when this segment contains 4-characters. 

2. A leading zero must be added to the Product Code when this segment contains 3-characters. 

3. A leading zero must be added to the Package Size Code when this segment contains 1-character. 

4. "**" must be placed in the Package Size Code segment when the product does not have a Package Size Code. The "**" indicates the product is in bulk form.

Transactions with incorrectly formatted NDC fields are rejected as erroneous and must be corrected and resubmitted. The exhibits in this section illustrate correct coding for the NDC field. Exhibit 5.9: Converting the NDC for a Non-bulk Product, illustrates how to convert an NDC for a non-bulk product to the format required by ARCOS. Exhibit 5.10: Converting the NDC for a Bulk Product, illustrates how to convert an NDC for a bulk product to the ARCOS format.

 

Fictitious Non-bulk Product (NDC Directory Configurations): (a) 1234 - 1234 - 12 (b) 12345 - 123 - 34 (c) 12345 - 1234 - 7 Converting To ARCOS NDC Configurations a. 01234 - 1234 - 12 ^_________________________leading zero added b. 12345 - 0123 - 34 ^________________leading zero added c. 12345 - 1234 - 07 ^_______________________leading zero added

Exhibit 5.9: Converting the NDC for a Non-bulk Product

 

Fictitious Bulk Product (NDC Directory Configurations): (a) 1234 - 1234 (b) 12345 - 123 (c) 12345 - 1234 Converting To ARCOS NDC Configurations a. 01234 - 1234 - ** ^____"**"added ^_________________________ leading zero added b. 12345 - 0123 - ** ^____"**"added ^___________________ leading zero added c. 12345 - 1234 - ** ^____"**"added

Exhibit 5.10: Converting the NDC for a Bulk Product

5.10.4 NDC Assignment

Identification of reportable controlled substances is always based on the Food and Drug Administration’s National Drug Code (NDC). All transaction records, except for transaction codes 7, 8, and F must contain an NDC. Any transaction record with missing or invalid NDC will be rejected and must be corrected before being resubmitted. Contact the FDA at the address provided in Exhibit 5.11: FDA Address, for information about the National Drug Code.

 

Food and Drug Administration
Bureau of Drugs, Drug Listing Staff
5600 Fishers Lane
Center for Drug Evaluation & Research (CDER), HFD-95
Rockville, Maryland 20857
Telephone: (301) 594-1086 
Hours: Monday-Friday 8:00am - 4:30pm EST/EDT

Exhibit 5.11: FDA Address

5.10.5 Submitting Labels

Pursuant to 21 CFR 1308.04, firms holding a DEA registration as a manufacturer must provide DEA (ARCOS) with information about each new product, new dosage form, or other unit form containing any quantity of controlled substance. This information must be submitted within 30 days after manufacturing begins. However, DEA (ARCOS) will also accept this information prior to the beginning of manufacturing. Two labels or other documents (e.g., Drug Listing Form, FDA 2657) which reflect the following information must be submitted:

1. The trade name, brand name, or other commercial name of the product; 

2. The generic or chemical name and quantity of each active ingredient, including both controlled and non-controlled substances (indicate what information is a proprietary trade secret); 

3. The National Drug Code assigned to the product, if any; and 

4. The weight of controlled substance as follows:

   (1) Finished Dosage Unit Products:

   Grams or milligrams per dosage unit

   (2) Bulk Products:

   Grams or milligrams per gram of powder
   Grams or milligrams per milliliter of liquid

Send this information to DEA (ARCOS). The address is listed on the contact information page at the front of this handbook. The Data Systems Unit (ARCOS) strongly advises each manufacturer to send this information before submitting transaction records for their new products. A transaction record that does not have a matching NDC in the ARCOS NDC Dictionary is rejected as erroneous and must be resubmitted. Call the Data Systems Unit (ARCOS) to find out if the NDC information for your firm’s new product has been added to the Dictionary.

All transactions for the new product that have occurred before the current reporting period, must be submitted as Late Transactions. Otherwise, these transactions will be rejected as errors because their transaction dates are not within the current reporting period. See Section 7, Edit Listings, for Late Transaction instructions.

5.10.6 Pseudo NDC’s

The pseudo NDC is a number developed by DEA (ARCOS) in consultation with the ARCOS registrant. A pseudo NDC may be requested from the DATA Systems Unit (ARCOS) when the NDC does not exist or is unavailable. This number enables ARCOS registrants to report transactions involving products for which an NDC is either unavailable or does not exist. Pseudo NDC’s are not listed in the Food and Drug Administration’s National Drug Code Directory.

5.10.7 Inner and Outer NDC Packages

A controlled substance product may have one NDC on an outer, larger package and a different NDC on the inner, smaller, individually-packaged units contained within the larger package. See Exhibit 5.12: Inner and Outer Packaging for an illustration. Either NDC may be used when reporting transactions and inventories. Care must be taken that the NDC corresponds to the product and package size being reported. A single NDC must never be used to identify two different package sizes of a product. The quantity reported will indicate the number of packages for that particular NDC.

 

Exhibit 5.12: Inner and Outer Packaging

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