Diversion Control Division, US Department of Justice, Drug Enforcement Administration

REPORTING > ARCOS > ARCOS Registrant Handbook > Section 6.0 - Manufacturing Activities

ARCOS Registrant Handbook

Section 6.0 - Manufacturing Activities

6.1 GENERAL

Section 6 contains ARCOS manufacturing instructions as they apply to the reporting of narcotics and psychotropics. The manufacturing activities and specific transaction code designations are identified and described in this section as follows: CODES 3, 4, W, M, L, J, K, Q, N, U. The narcotic and psychotropic drug statistics derived from these manufacturing transaction codes are used primarily for fulfillment of United States treaty obligations. The United States is a signatory to the (a) Single Convention on Narcotic Drugs, 1961 and (b) Convention on Psychotropic Substances, 1971, and as such is required to provide yearly statistics to the United Nations International Narcotics Control Board.

6.1.1 Reporting by Bulk and Dosage Form Manufacturers

Manufacturers of bulk powders, bulk dosage formulations and/or dosage package size formulations of any Schedule I & II controlled substance, any narcotic controlled substance in Schedule III, and any listed psychotropic controlled substances in Schedules III and IV must report those manufacturing activities as set forth in this section. The manufacturers of controlled substances in Schedules I and II and/or any narcotic in Schedule III are also required to report on those applicable transaction activities relating to inventories, acquisitions and dispositions as set forth in this handbook.

6.1.2 Reporting by Packers, Repackers and Relabelers

Manufacturers registered for activities such as packing, repacking and relabeling of controlled substances in Schedules I and II and/or any narcotic in Schedule III are not required to report the actual packing, repacking or relabeling manufacturing activity, but must report other manufacturing activities as set forth in this section, as well as activities that relate to inventories, acquisitions, and dispositions as set forth in this handbook.

6.1.2.1 Definitions:

The following definitions are provided for clarification.

  1. A packer/repacker is a registrant that packs a product into a container (i.e., packer) or repacks a product into different size containers, such as changing a package of 50 capsules to 5 packages of 10 capsules each (i.e., repacker).
  2. A labeler/relabeler is a registrant that affixes the original label to a product (i.e., labeler) or changes in any way the labeling on a product without affecting the product or its container (i.e, relabeler). The "relabel" term implies that the package size remains unchanged with changes being made only in brand name, NDC number, distributor, etc. See the following example and reporting scenario:

6.1.2.2 Scenario for Repackaging and Relabeling

A manufacturer purchases 50,000 codeine phosphate tablets (NDC 00034-4156-**). The manufacturer subsequently repackages and relabels to package size of 50 per carton (NDC 00036-4156-01) and package size of 100 per carton (NDC 00036-4156-02). On June 23, 1997, 50 and 150 cartons of NDC products 00036-4156-01 and 00036-4156-02, respectively, are sold to a distributor.

6.1.2.3 ARCOS Automated Report:

(numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13)
PP1234567 P 000344156** 00050000 PP0233560 940690023 062397 0000000001 E25
PP1234567 S 00036415601 00000050 PM0105444 940690023 062397 0000000002 E25
PP1234567 S 00036415602 00000150 PM0105444 940690023 062397 0000000003 E25

6.1.2.4 ARCOS Manual Report:

(numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11-13) (14)
PP1234567 P 000344156** 050000 PP0233560 940690023 70623 00001
PP1234567 S 00036415601 000050 PM0105444 940690023 70623 00002
PP1234567 S 00036415602 000150 PM0105444 940690023 70623 00003

6.1.3 Reporting Non-Manufacturing Activities

All non-manufacturing activities (i.e., those not described in Section 6 of this handbook) such as acquisition transactions (i.e., codes P, R, G, V), disposition transactions (i.e., codes S, Y, T, Z,), inventory transactions (i.e., codes 1,3,5,8) and miscellaneous transactions (i.e., codes 7, F, X) will continue to be reported on the dates that the transaction actually occurred consistent with the format described in this handbook.

6.1.4 Manufacturing Reporting Guidelines

  • Manufacturing activities (i.e., transaction codes M, U, K, L, Q, J, W, and N) may be reported quarterly or annually. In either instance the date of the manufacturing transaction activity must be shown as the last day of the calendar year or quarter being reported.
  • When reporting specific manufacturing transaction codes identified in Section 6, the quantities of NDC products being reported may be expressed (a) by listing the amount of the NDC product containing the controlled substance in its original salt or derivative form (i.e., not converted to anhydrous base drug) or (b) in terms of anhydrous base controlled substance utilizing the salt conversion factors listed in Appendix 3. The ARCOS system will automatically convert all salt/derivative formulations to appropriate quantities of anhydrous controlled substance.
  • If the manufacturer chooses to report in terms of anhydrous base substance, the NDC product being reported on the transaction record must reflect the anhydrous base substance and not the specific salt/derivative form.
  • Please refer to the reporting matrix at Appendix 1 for automated reporting and at Appendix 2 for manual reporting as an aid in identifying the required fields of information for each acquisition, disposition, inventory, and manufacturing activity transaction code.

6.2 NARCOTICS

The specific types of ARCOS manufacturing activities required for all narcotics listed in Schedules I through III are:

  1. Quantity manufactured.
    This means the amount in grams of base weight of all reportable controlled substances manufactured or synthesized by the manufacturer. Base weight conversion factors are listed in Appendix 3.
  2. Quantity used for the manufacture of other preparations.
    This means the amount in grams of base weight of each controlled substance in Schedules I and II used to produce (a) Schedule III, IV, or V preparations or (b) exempt chemical preparations (21 CFR 1308.23), or exempted prescription products (21 CFR 1308.32).
  3. Quantity held in stock on 31 December.
    This means the amount in grams of base weight of all reportable controlled substances that physically exists in the manufacturer's location as of December 31 of the reporting year. It is also essential that the manufacturer include that quantity of each controlled substance that is considered to be in-process material (i.e. that quantity of controlled substance which is not, at the time of the year-end inventory, in the bulk or finished dosage formulation stage). In-process inventory are those quantities of reportable drug stocks which are not included in a manufacturer's calculation of finished/dosage form inventory.

6.2.1 Manufacturing Narcotics

Code "M" is the transaction code to be used by all narcotic manufacturers that synthesize a controlled substance to produce the following: (a) bulk powder form, (b) large bulk quantities of formulated, but non-packaged tablets, capsules, or vials or large quantities (e.g., drum) of drugs in solution with known concentration. An "M" transaction is to be reported at the end of each calendar year or quarter and shall reflect the total quantity of each bulk substance produced during that reporting period. Individual "M" transactions for the same narcotic during the reporting period may be consolidated and reported as one "M" transaction.

Please refer to Appendices 1 and 2 for additional information on the required fields of information for the "M" transaction. Note, also, that for each unique NDC number, transaction code M must be reported once at the end of each calendar quarter or annually on December 31.

For various reasons, if a quantity of controlled substance previously reported as manufactured must be returned to the production process (i.e. reworked), the only ARCOS data reported is the overall net change to the previously reported controlled substance.

  1. If less is produced after reworking than was previously reported, an "N" transaction code (i.e. non-recovered waste) would be reported reflecting the difference in weight of controlled substance between the new manufactured data and the previously reported manufactured data. Do not report the newly manufactured product; report only the difference (i.e. code "N").
  2. If more is produced after reworking than was previously reported, the additional quantity of controlled substance in excess of the previously reported controlled substance is to be reported as an "M" transaction.
  3. If no net change occurs with reworked material, nothing need be reported.

6.2.1.1 Manufacturing Scenario for "M" Transaction Code

On December 15, 1997, a manufacturer synthesized a total of 1,624,669 grams of thebaine (NDC 00406-1686-**), 100% pure.

6.2.1.2 ARCOS Automated Report:

(numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13)
PP1234567 M 004061686** 01624669 3 123197 1000 0000001234 E25

6.2.1.3 ARCOS Manual Report:

(numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11-13) (14)
PP1234567 M 004061686** 001624 4 1000 71231 01234
PP1234567 M 004061686** 000669 3 1000 71231 01235

NOTE: Since the ARCOS Manual Report layout allows for only 6 positions in the quantity field, the manufacturer submits two transactions; one for the manufacture of 1,624 kilograms (unit=4) and the other for 669 grams (unit=3).

6.2.2 Narcotics: Quantity Used To Produce Preparations

The "K" transaction code represents the mechanism used to identify the amount of narcotics used to produce Schedule III, IV, V, or exempt chemical preparations.

The "K" transaction code will be reported quarterly or annually on December 31 for each narcotic listed in Schedules I & II used to produce (1) Schedule III, IV & V preparations and/or (2) exempt chemical preparations (21 CFR 1308.23).

Please refer to Appendices 1 and 2 for additional information on the required fields of information for the "K" transaction. Note, also, that for each unique NDC number, transaction code K must be reported once at the end of each calendar quarter or annually on December 31.

6.2.2.1 Manufacturing Scenario for "K" Transaction Code

On April 30, 1997, a manufacturer utilized 10,134 milligrams of the bulk schedule II narcotic, hydrocodone bitartrate (NDC 00019-1582-**), 99% pure to produce a Schedule III, IV, V product or an exempt chemical preparation containing the same narcotic (i.e., hydrocodone bitartrate).

6.2.2.2 ARCOS Automated Report:

(numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13)
PP1234567 K 000191582** 00010134 2 123197 0990 0000001000 E25

6.2.2.3 ARCOS Manual Report:

(numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11-13) (14)
PP1234567 K 000191582** 010134 2 0990 61231 01000


6.2.3 Narcotics: Quantity Used to Produce a Different Narcotic

The United States is required to provide statistics reflecting the quantities of specific narcotics utilized to generate chemically different ARCOS reportable narcotic substances. Transaction code U is used to report this narcotic conversion data. The following list represents a few examples of the specific narcotics to be reported to the UN.


Substance Used Substance Obtained
Opium Morphine, Codeine, Thebaine
Codeine Dihydrocodeine, Hydrocodone
Ecgonine Cocaine
Thebaine Codeine, Dihydrocodeine, Hydrocodone, Oxycodone,
Thebacone, Buprenorphine, Nalbuphine, Naloxone,
Naltrexone

Please refer to Appendices 1 and 2 for additional information on the required fields of information for the "U" transaction. Note, also, that for each unique NDC number, transaction code U must be reported once at the end of each calendar quarter or annually on December 31.

6.2.3.1 Manufacturing Scenario for "U" Transaction Code

On April 31, 1997, a manufacturer utilized 50kg of bulk codeine sulfate powder (NDC 00045-0974-**), 99% pure to produce 200 gm of dihydrocodeine, 98% purity. This scenario would require the submission of a "U" transaction to report the codeine sulfate utilization and a corresponding "M" transaction to report the manufacture of the narcotic substance which was produced (i.e., dihydrocodeine).

6.2.3.2 ARCOS Automated Report:

(numbers in parenthesis indicate data field numbers):

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13)
PP1234567 U 000450974** 00000050 4 123197 0990 000000001 E25
PP1234567 M 000087803** 00000200 3 123197 0980 000000002 E25

6.2.3.3 ARCOS Manual Report:

(numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11-13) (14)
PP1234567 U 000450974** 000050 4 0990 71231 00001
PP1234567 M 000087803** 000200 3 0980 71231 00002

6.2.4 Inventory Held in Stock on 31 December

The "3" transaction code is used to report the annual year-end inventory of all ARCOS reportable controlled substances submitted by manufacturers and distributors in accordance with 21 CFR 1304.33. Inventories for all physically stored bulk or dosage form controlled substances are reported by a code "3" transaction. This inventory is to be taken at the close of business on December 31 of the reported year. THIS IS THE ONLY DATE WHICH WILL BE ACCEPTED FOR TRANSACTION CODE 3.

Transaction code 4 is used to report the annual year-end in-process inventory for all reportable controlled substances by manufacturer in accordance with 21 CFR 1304.33. On December 31 of each year, certain manufacturers may have some quantities of controlled substances that are still in the manufacturing production chain (i.e., not a finished bulk or dosage form product). Manufacturing inventories of this type (i.e., in-process) are to be reported with a transaction code 4. The in-process manufacturing inventory is to be taken at the close of business on December 31 of the reported year. THIS IS THE ONLY DATE WHICH WILL BE ACCEPTED FOR TRANSACTION CODE 4.

Please refer to Appendices 1 and 2 for additional information on the required fields of information for transaction codes "3"and "4".

6.2.5 Manufacturing Scenarios for "3" and "4" Transaction Codes

On December 31, 1997, a manufacturer reported a year end inventory for (a) 53,967 grams of 100% pure bulk methadone hydrochloride (NDC 00019-1510-**), (b) 158,000 filled bottles of dronabinol capsules (NDC 00051-0021-01), (c) 89,000 ml of morphine sulfate solution (NDC 00054-3751-**) and (d) 365,000 liters of morphine sulfate solution (NDC 00186-0686-**) contained in the in-process production stream.

6.2.5.1 ARCOS Automated Report:

(numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13)
PP1234567 3 000191510** 00053967 3 123197 1000 0000000001 E25
PP1234567 3 00051002101 00158000 123197 0000000002 E25
PP1234567 3 000543751** 00089000 5 123197 0000000003 E25
PP1234567 4 001860686** 00365000 6 123197 0000000004 E25

6.2.5.2 ARCOS Manual Report:

(numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11-13) (14)
PP1234567 3 000191510** 053967 3 1000 71231 00001
PP1234567 3 00051002101 158000 71731 00002
PP1234567 3 000543751** 089000 5 71231 00003
PP1234567 4 001860686** 365000 6 71231 00004

6.3 PSYCHOTROPICS

The specific types of manufacturing activities required for all psychotropic substances listed in Schedules I through IV are:

  1. Quantity Manufactured.
    This means the amount of base weight controlled substance (in grams) manufactured or synthesized by the manufacturer. Base weight conversion factors are listed in Appendix 3.
  2. Quantity used for the manufacture of non-psychotropic substances.
    This means the quantity of bulk controlled substance used in a calendar quarter or year to produce a non-psychotropic substance. A non-psychotropic substance is any substance not listed in any Schedule of the 1971 Psychotropic Convention.
  3. Quantity used for the manufacture of exempt preparations.
    This means the quantity of bulk controlled substance used in a calendar quarter or year to produce (a) Excluded non-narcotic substances (21 CFR 1308.21), (b) Exempt chemical preparations (21 CFR 1308.23), or (c) Exempted prescription products (21 CFR 1308.31).
  4. Quantity held in stock on 31 December.
    This means the amount (in grams) of base weight of all reportable controlled substances that physically exists in the manufacturers' location as of December 31 of the reporting year. It is also essential that the manufacturer include that quantity of each controlled substance that is considered to be in-process material (i.e., that quantity of controlled substance which is not, at the time of the time of the year-end inventory, in the bulk or finished dosage formulation stage).

6.3.1 Psychotropic Drugs

The psychotropic controlled substances for which manufacturing activities must be reported are as follows (shown by CSA Schedule and covered in 21 CFR 1304.33). Manufacturers are not required to report acquisition or disposition transactions for any of the psychotropic controlled substances in Schedules III and IV listed below.

SCHEDULE I SUBSTANCES

(1) Diethyltryptamine
(2) Dimethyltryptamine
(3) Lysergic acid diethylamide(LSD, LSD-25)
(4) Mecloqualone
(5) Mescaline
(6) Psilocyn
(7) Psilocybin
(8) 4-methyl-2,5-dimethoxyamphetamine(STP)
(9) Tetrahydrocannabinols(THC, certain isomers)
(10)Ethylamine analogue of PCP(PCE)
(11)Pyrrolidine analogue of PCP(PCPy)
(12)Thiophene analogue of PCP(TCP)
(13)Methaqualone

SCHEDULE II SUBSTANCES

(1) Amobarbital
(2) Amphetamines
(3) Methamphetamine
(4) Secobarbital
(5) Methylphenidate
(6) Pentobarbital
(7) Phenmetrazine
(8) Phencyclidine (PCP)
(9) Glutethimide

SCHEDULE III SUBSTANCES

(1) Benzphetamine
(2) Cyclobarbital
(3) Methyprylon
(4) Phendimetrazine

SCHEDULE IV SUBSTANCES

(1) Barbital
(2) Diethylpropion (Amfepramone)
(3) Ethchlorvynol
(4) Ethinamate
(5) Lefetamine (SPA)
(6) Mazindol
(7) Meprobamate
(8) Methylphenobarbital
(9) Phenobarbital
(10)Phentermine
(11)Pipradrol

6.3.2 Manufacturing Psychotropics

Code "M" is the transaction code to be used by all psychotropic manufacturers actually synthesizing a controlled substance to produce (1) a bulk powder form, (2) large bulk quantities of formulated but non-packaged tablets, capsules, vials or (3) large quantities (e.g.,drum) of drugs in solution with known concentration. Those bulk manufacturers synthesizing a new chemical substance or producing a new chemical via an extraction process are to report this activity using an "M" transaction code designation.

An "M" transaction is to be reported each calendar quarter or year and shall reflect the total quantity of each bulk chemical produced during the reporting period. Individual "M" transactions for the same psychotropic substance during the reporting period may be consolidated and reported as one "M" transaction.

Please refer to Appendices 1 and 2 for additional information on the required fields of information for the "M" transaction. Note, also, that for each unique NDC number, transaction code M must be reported once at the end of each calendar quarter or annually on December 31.

6.3.2.1 Manufacturing Scenario for "M" Transaction Code

On June 30, 1997, a manufacturer synthesized a total of 4,669 grams of 3,4-methylenedioxyamphetamine (MDA) (NDC 00073-1002-**), 97% pure.

6.3.2.2 ARCOS Automated Report:

(number in parenthesis indicate data field entries)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13)
PP1234567 M 000731002** 00004669 3 123197 0970 0000001234 E25

6.3.2.3 ARCOS Manual Report:

(number in parenthesis indicate data field entries)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11-13) (14)
PP1234567 M 000731002** 004669 3 0970 641231 01234

6.3.3 Psychotropics: Quantity Used to Make Non-Psychotropic Substances

The "U" transaction code is the mechanism employed to capture the conversion of the listed psychotropics to a non-psychotropic substance. The "U" transaction code will be used to report this activity on a quarterly or annual basis. Individual "U" transactions for the same psychotropic substances during the reporting period may be consolidated and reported as one "U" transaction.

Please refer to Appendices 1 and 2 for additional information on the required fields of information for the "U" transaction. Note, also, that for each unique NDC number, transaction code U must be reported once at the end of each calendar quarter or annually on December 31.

6.3.3.1 Manufacturing Scenario for "U" Transaction Code

On September 30, 1997, a manufacturer purchased 75 kg of bulk levmethamphetamine base powder (NDC 00079-1470-**), 99% pure from another manufacturer under DEA order form number 942356780 and subsequently utilized 50 kg of bulk levmethamphetamine (NDC 00079-1470-**), to produce a non-psychotropic substance (i.e., selegiline). This scenario would require the submission of a "P" transaction to report the purchase of the bulk levmethamphetamine and a corresponding "U" transaction to report the levmethamphetamine utilization.

6.3.3.2 ARCOS Automated Report:

(number in parenthesis indicate data field entries)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13)
PP1234567 P 000791470** 00000075 4 PG0208947 942356780 093097 0990 000001234 E25
PP1234567 U 000791470** 00000050 4 123197 0970 000001235 E25

6.3.3.3 ARCOS Manual Report:

(number in parenthesis indicate data field entries)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11-13) (14)
PP1234567 P 000791470** 000075 4 PG0208947 942356780 0990 70930 01234
PP1234567 U 000791470** 000050 4 0990 71231 01235

6.3.4 Psychotropics: Quantity Used to Manufacture Exempt Preparations

Transaction code K is used to report manufacturing activity involving the utilization of selected psychotropics to produce (1) exempt chemical preparations (21 CFR 1308.23), (2) excluded nonnarcotic substances (21 CFR 1308.21) or (3) exempted prescription products. (21 CFR 1308.32). The "K" transaction code will be used to report this activity on a quarterly or annual basis. Individual "K" transactions for the same psychotropic substances during the reporting period may be consolidated and reported as one "K" transaction.

Please refer to Appendices 1 and 2 for additional information on the required fields of information for the "K" transaction. Note, also, that for each unique NDC number, transaction code K must be reported once at the end of each calendar quarter or annually on December 31.

6.3.4.1 Manufacturing Scenario for "K" Transaction Code

On March 31, 1997, a manufacturer utilized 4 milligrams of the bulk tenocyclidine hydrocloride powder (NDC 00079-0248-**), 99% pure to produce (a) an exempt chemical preparation containing the same psychotropic (i.e., tenocyclidine hydrochloride); (b) utilized 100 micrograms of bulk glutethimide powder (NDC 00079-0024-**) 98% pure to produce an exempted prescription product and utilized 250 grams of bulk meprobamate powder (NDC 00436-0809-**), 95% pure to produce an excluded substance.

6.3.4.2 ARCOS Automated Report:

(TENOCYCLIDINE HCL) (numbers in parenthesis indicate data field entries).

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13)
PP1234567 K 000790248** 00000004 2 123197 0990 0000001234 E25

6.3.4.3 ARCOS Manual Report:

(TENOCYCLIDINE HCL) (numbers in parenthesis indicate data field entries).

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11-13) (14)
PP1234567 K 000790248** 000004 2 0990 71231 01234

6.3.4.4 ARCOS Automated Report:

(GLUTETHIMIDE) (numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13)
PP1234567 K 000790024** 00000100 1 123197 0980 0000001234 E25

6.3.4.5 ARCOS Manual Report:

(GLUTETHIMIDE) (numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11-13) (14)
PP1234567 K 000790024** 000100 1 0980 71231 01234

6.3.4.6 ARCOS Automated Report:

(MEPROBAMATE) (numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13)
PP1234567 K 0004360809** 00000250 3 123197 0950 0000001234 E25

6.3.4.7 ARCOS Manual Report:

(MEPROBAMATE) (numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11-13) (14)
PP1234567 K 004360809** 000250 3 0950 71231 01234

6.3.5 Inventory Held in Stock on 31 December

Transaction code 3 is used to report annual year-end inventory of all ARCOS reportable controlled substances submitted by manufacturers and distributors in accordance with 21 CFR §1304.33. Inventories for all physically stored, bulk or dosage form controlled substances are reported by a code "3" transaction. This inventory is to be taken at the close of business on December 31 of the reporting year. THIS IS THE ONLY DATE WHICH WILL BE ACCEPTED FOR TRANSACTION CODE 3.

Transaction code 4 is used to report the annual year-end in-processinventory for all reportable controlled substances by manufacturers in accordance with 21 CFR 1304.33. On December 31 of each year, certain manufacturers may have some quantities of controlled substances that are still in the manufacturing production chain (i.e., not a finished bulk or dosage form product). Manufacturing inventories of this type (i.e., in-process) are to be reported with a transaction code 4. The in-processmanufacturing inventory is to be taken at the close of business on December 31 of the reported year. THIS IS THE ONLY DATE WHICH WILL BE ACCEPTED FOR TRANSACTION CODE 4.

Please refer to Appendices 1 and 2 for additional information on the required fields of information for transaction codes "3" and "4".

6.3.6 Manufacturing Scenario for "3" and "4" Transaction Codes:

On December 31, 1997, a manufacturer reported a year end inventory of (a) 153,967 grams of 100% pure bulk benzphetamine hydrochloride (NDC 00079-0046-**), (b) 8900 ml of phenobarbital elixir (NDC 00349-4035-**) and (c) 5,000 liters of fentanyl injectable solution (NDC 50458-0030-**) contained in the in-process production stream.

6.3.6.1 ARCOS Automated Report:

(numbers in parenthesis indicate data fields)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13)
PP1234567 3 000790046** 00153967 3 1231967 1000 0000000001 E25
PP1234567 3 000349403** 00008900 5 1231967 0000000002 E25
PP1234567 4 504580030** 00005000 6 1231967 0000000003 E25

6.3.6.2 ARCOS Manual Report:

(numbers in parenthesis indicate data fields)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11-13) (14)
PP1234567 3 000790046** 00153967 3 1000 71231 00001
PP1234567 3 003494035** 008900 5 71231 00002
PP1234567 4 504580030** 005000 6 71231 00003

6.4 MANUFACTURING ACTIVITIES FOR CODES N, W, L, Q, J

The following manufacturing activities represent additional ARCOS reportable transactions for narcotic and psychotropic controlled substances.

6.4.1 Non-recoverable Waste (Code N)

In some manufacturing processes, quantities of narcotic or psychotropic controlled substances may be lost due to accidental spillage or inherent chemical reactions associated with various steps of the overall chemical manufacturing procedure. These losses will result in variable yields of the finished bulk drug substance. Chemical losses due to spillage or inherent chemical reactions are considered non-recoverable waste when the lost material (waste) cannot be returned to the original manufacturing process. Code "N" is the transaction code to be used to reflect such losses. The "N" transaction activity will be reported quarterly or annually for each ARCOS reportable narcotic and /or psychotropic controlled substance listed in Schedules I through IV.

Please refer to Appendices 1 and 2 for additional information on the required fields of information for the "N" transaction. Note, also, that for each unique NDC number, transaction code N must be reported once at the end of each calendar quarter or annually on December 31.

Manufacturing Scenario for "N" Transaction Code

From February 1 through June 30, 1997, a manufacturer's journal on non-recoverable waste (CODE-N) was maintained and updated at the end of each day, reflecting a total of 250 grams of non-recoverable waste associated with the manufacture of bulk raw hydrocodone bitartrate powder (NDC 00373-4461-**) and a non-recoverable waste of 38 grams of bulk raw meprobamate powder (NDC 00074-5434-**).

6.4.1.1 ARCOS Automated Report:

(numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11-13) (14)
PG1234567 N 003734461** 000250 3 1000 61231 00001
PG1234567 N 000745344** 000038 3 1000 61232 00002

6.4.1.2 ARCOS Manual Report:

(numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11-13) (14)
PG1234567 N 003734461** 000250 3 1000 61231 00001
PG1234567 N 000745344** 000038 3 1000 61232 00002

6.4.2 Recovered Waste (Code W)

During the manufacturing processes of controlled narcotics and psychotropics, some bulk raw powder or bulk dosage form products may accumulate or be held in stock for later processing. A narcotic or psychotropic substance accumulated during the manufacturing process and held for later processing is recovered waste. In other instances, this residue cannot be reprocessed, but will be returned to storage (reported as recovered waste), accumulated for a period of time, and then destroyed. Any waste returned to inventory is considered recovered waste. Code "W" is the transaction code used to reflect this type of manufacturing activity. The "W" transaction activity must be reported quarterly or annually for each ARCOS reportable narcotic or psychotropic substance. Please refer to Appendices 1 and 2 for additional information on the required fields of information for the "W" transaction. Note, also, that for each unique NDC number, transaction code W must be reported once at the end of each calendar quarter or annually on December 31.

Manufacturing Scenario for "W" Transaction Code:

From May 1 through August 30, 19977 a manufacturer's journal on recoverable waste (CODE-W) was maintained and updated at the end of each day, reflecting measurable losses of hydrocodone bitartrate capsules (NDC 00404-0016-**) and bulk phenobarbital raw powder (NDC 00019-6584-**) due to spillage, contamination, and/or machine residue accumulation. The following entries report the losses due to spillage (552 capsules) and machine residue accumulation (1250 GM raw powder).

6.4.2.1 ARCOS Automated Report:

(numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13)
PG1234567 W 004040016** 00000552 123197 0000000001 E25
PG1234567 W 000196584** 00001250 3 123197 1000 0000000002 E25

6.4.2.2 ARCOS Manual Report:

(numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11-13) (14)
PG1234567 W 004040016** 000552 71231 00001
PG1234567 W 000196584** 001250 3 1000 71231 00002

6.4.3 Reversing (Code L)

Manufacturers involved in the normal production of preparations containing narcotic or psychotropic substances in Schedules III or IV, exempt chemical preparations, excluded products, or exempted prescription products may decide to recover the original bulk narcotic or psychotropic contained in the preparations for future use in other narcotic or psychotropic manufacturing procedures. Code "L" is the transaction code used to report this type of activity. The "L" transaction activity must be reported quarterly or annually for each ARCOS reportable narcotic or psychotropic substance recovered in schedules I and II. Please refer to Appendices 1 and 2 for additional information on the required fields of information for the "L" transaction. Note, also, that for each unique NDC number, transaction code L must be reported once at the end of each calendar quarter or annually on December 31.

Manufacturing Scenario for "L" Transaction Code:

From May 1 through August 30, 1997, a manufacturer's journal on chemical procedures cited the chemical recovery of 30 kgs of bulk raw dihydrocodeine bitartrate powder (NDC 00794-0111-**) and 5260 grams of bulk raw butalbital powder (NDC 00441-0525-**) from exempt prescription products. The following examples demonstrate the ARCOS reporting procedure.

6.4.3.1 ARCOS Automated Report:

(numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13)
PG1234567 L 007940111** 00000030 4 123197 1000 0000000001 E25
PG1234567 L 004410525** 00005260 3 123197 1000 0000000002 E25

6.4.3.2 ARCOS Manual Report:

(numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11-13) (14)
PG1234567 L 007940111** 000030 4 1000 71231 00001
PG1234567 L 004410525** 005260 3 1000 71231 00002

6.4.4 Sampling (Code Q)

A quality control feature associated with most manufacturing procedures involves the removal of a designated quantity of the manufactured product for stability testing (i.e. melting point, flashpoint, optical rotation, GLC-NMR spectra, etc.) or government sampling requirements. Any quantity of ARCOS reportable bulk or dosage form narcotic or specific psychotropic product (see selected list, 6.3.1) removed from inventory for sampling purposes is to be reported. Code "Q" is the transaction code used to reflect this type of activity. The "Q" transaction activity must be reported quarterly or annually for each ARCOS Reportable narcotic or psychotropic substance in Schedules I through IV.

Please refer to Appendices 1 and 2 for additional information on the required fields of information for the "Q" transaction. Note, also, that for each unique NDC number, transaction code Q must be reported once at the end of each calendar quarter or annually on December 31.

6.4.5 Return of Samples to Inventory (Code J)

There are occasions when samples removed for quality control are returned to the manufacturing process. Code "J" is the transaction code used to reflect this type of activity. For each unique NDC number, report one transaction code J for the reporting period.

Please refer to Appendices 1 and 2 for additional information on the required fields of information for the "J" transaction. Note, also, that for each unique NDC number, transaction code J must be reported once at the end of each calendar quarter or annually on December 31.

Manufacturing Scenarios for "Q" & "J" Transaction Codes:

The following example demonstrates the ARCOS reporting procedure for (a) removal of samples from inventory (Code Q) and (b) return of samples to inventory (Code J).

On May 22, 1997, a manufacturer withdrew a sample of 10 bottles of hydrocodone capsules (NDC 00403-4522-30) for quality control testing; on November 10, 1997, the manufacturer returned 8 bottles of hyrdocodone bitartrate capsules (NDC 00403-4522-30) to inventory.

6.4.5.1 ARCOS Automated Report:

(numbers in parenthesis indicate data field numbers)

6.4.5.2 ARCOS Manual Report:

(numbers in parenthesis indicate data field numbers)

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11-13) (14)
PG1234567 Q 00403452230 000010 71231 00001
PG1234567 J 00403452230 000008 71231 00002

NOTE: Exception to Usage Reporting

There is one instance in manufacturing where no reporting is needed:

When a quantity of a drug is used to produce an end product (such as a preparation) which contains the same drug in the same schedule, no reporting is necessary. For example, if a Schedule II drug is used to produce a Schedule II preparation containing that drug, it is not reported to ARCOS.

 

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