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ARCOS
> Registrant
Handbook > Section 6
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.
-
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).
-
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:
-
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.
-
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).
-
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.
-
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").
-
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.
-
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:
-
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.
-
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.
-
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).
-
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-process inventory 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-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".
6.3.6 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) |
(12) |
(13) |
| PG1234567 |
N |
|
003734461** |
00000250 |
3 |
|
|
123197 |
|
1000 |
0000000001 |
E25 |
| PG1234567 |
N |
|
000745344** |
00000038 |
3 |
|
|
123197 |
|
1000 |
0000000002 |
E25 |
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)
| (1) |
(2) |
(3) |
(4) |
(5) |
(6) |
(7) |
(8) |
(9) |
(10) |
(11) |
(12) |
(13) |
| PG1234567 |
Q |
|
00403452230 |
00000010 |
|
|
|
123197 |
|
|
0000000001 |
E25 |
| PG1234567 |
J |
|
00403452230 |
00000008 |
|
|
|
123197 |
|
|
0000000002 |
E25 |
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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