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)

Positions 50-51:	Month (01-12)
Positions 52-53:	Day (01-31)
Positions 54-55:	Year (last two-digits of the year 95, 96, etc.)

Coding Examples:
	January 1, 1996:	010196
	November 11, 1997:	111197

Column 60:	Year (last digit of the year, 0-9)
Columns 61-62:	Month (0I-12)
Columns 63-64:	Day (0I-31)

Coding Examples:
	January 1, 1996:	60101
	November 11, 1997:	71111

5.15.4 Discussion: Transaction Date

A transaction date must be entered for all transactions. The transaction date must be 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 must be 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).