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               Comprehensive Methamphetamine Control Act FAQ
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                               January 7, 1998

Question: Is a business that warehouses pseudoephedrine drug products for a
major distributor and delivers to the major distributor's customer, a military
commissary, required to register?

Answer: Yes, CFR 1309.21 states every person who distributes, imports, or
exports any List I Chemical shall obtain annually a registration specific to the
List I Chemicals to be handled. The Comprehensive Methamphetamine Control Act of
1996 (MCA) eliminated the exemption for legal drug products which contain either
combination ephedrine, pseudoephedrine, or phenylpropanolamine. It was required
that those who distribute these List I Chemical drug products submit an
application for registration with the Drug Enforcement Administration on or
before December 3, 1997 for pseudoephedrine and phenylpropanolamine drug
products and on or before July 12, 1997 for combination ephedrine drug products,
unless otherwise exempt. Those who missed these application deadlines are
required to both submit an application and have the application approved before
they can legally distribute these products.

Question: Are there additional case examples or scenarios that may be
encountered as a result of the Comprehensive Methamphetamine Control Act of
1996?

Answer: Presented for your information are actual product diversion case
examples reported to DEA. These may be indicative of the type of activities that
may be encountered. DEA does not recommend store personnel become engaged in
personal confrontation but that police authorities be notified.

1) In July 1997, U.S. Border Patrol agents seized over one million
pseudoephedrine tablets concealed in a motor home at a border checkpoint in the
southwestern United States. Invoice information indicated that the tablets had
been sold to a company, a wholesale general merchandise/wholesale grocer. The
company which sold the pseudoephedrine is described by Dunn &Bradstreet codes as
a wholesale business involved in non-durable goods (gifts and novelties).

2) Subsequent to a drug investigation in July 1997, law enforcement personnel in
the western United States arrested three subjects and seized a total of 144
cases of pseudoephedrine tablets, which contained 144 bottles of 60 count x 60
milligram (mg) pseudoephedrine tablets (a total of 1,244,160 tablets). Follow-up
investigation revealed that the pseudoephedrine had been sold by an
import/export, general warehousing, and transportation facility to a wholesale
supplier of variety store goods.

NOTE: Each case (144 bottles of 60 count x 60 mg pseudoephedrine tablets - a
total of 8,640 tablets) contains enough pseudoephedrine to illicitly manufacture
approximately 11 ounces of methamphetamine.

3) In July 1997, DEA personnel in the western United States seized approximately
142 cases of pseudoephedrine tablets, which had been repackaged into 21 plain
boxes. The cases had been shipped from a wholesaler of nondurable goods (gifts
and novelties). According to the subject taken into custody, the pseudoephedrine
was purchased as a "side job" for his/her truck stop distributor’s business on a
"cash basis" for someone else. Subsequent investigation revealed that a total of
120 cases had previously been shipped to this same company.

4) In August 1997, DEA personnel in the western United States seized 40 cases of
pseudoephedrine tablets, each containing 288 bottles of 120 count x 60 mg
pseudoephedrine tablets (a total of 1,382,400 tablets). The pseudoephedrine was
sold from a wholesaler of nondurable goods (gifts and novelties) to a wholesaler
of food products. The pseudoephedrine had been seized at a distribution center
(transshipment point) and had been labeled as "foodstuff/vitamins."

NOTE: Each of these cases (288 bottles of 120 count x 60 mg pseudoephedrine
tablets--a total of 34, 560 tablets) contains enough pseudoephedrine to
illicitly manufacture approximately 1.24 kilograms (2.7 pounds) of
methamphetamine.

5) In August 1997, fire department and police personnel responded to an
apartment fire on the East Coast. The suspect was arrested upon his return to
the apartment after having taken his girlfriend to the hospital for second and
third degree burns over 40 percent of her body. A subsequent search of the
residence revealed that the source of the fire was the presence of an extraction
laboratory. (An extraction laboratory removes ephedrine/pseudoephedrine from
over-the-counter products using a chemical process that separates the desired
final product from the binders and other ingredients contained in the tablets.
This reduces the ephedrine/pseudoephedrine into a bulk, powder form to be used
in the illicit manufacture of methamphetamine. The same process may be used for
over-the-counter phenylpropanolamine products for the illicit manufacture of
amphetamine.)

6) In September 1997, police seized 132 boxes of pseudoephedrine tablets (over
one million tablets) during a traffic stop in the Mid-West. Each box contained
144 bottles of 60 count x 60 mg pseudoephedrine tablets. The subject detained in
this case obtained the pseudoephedrine from an import company.

7) In September 1997, fire department personnel on the West Coast responded to a
report of smoke coming from a residence. The source of the fire was an explosion
from a clandestine methamphetamine laboratory.

8) In September 1997, a clandestine methamphetamine laboratory was seized from a
residence in the Southwestern United States. The lab was discovered by law
enforcement personnel who were investigating a possible negligent homicide
involving a four-year old child who may have been poisoned by the
chemicals/fumes from the lab.

9) In October 1997, law enforcement and fire department personnel responded to a
suspicious fire in the Mid-West. The apparent cause of the fire was determined
to be a clandestine methamphetamine laboratory, which was found in the attic
along with the body of one female who had died in the blaze.

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                              October 23, 1997

                        SUBMISSION FOR DEA DIVERSION

Question: Regarding Chemical Registration, has there been an official change in
the chemical application fee amount and the application deadline?

Response: DEA published two notices in the Federal Register on October 17, 1997
relating to the implementation of the Comprehensive Methamphetamine Control Act
of 1996.

The first notice relates to DEA's waiving a substantial portion of the chemical
application fee for distributors of pseudoephedrine, phenylpropanolamine, and
combination ephedrine drug products.

Effective upon publication, the application fee for a chemical registration to
distribute pseudoephedrine, phenylpropanolamine, or combination ephedrine drug
products has been reduced from $595.00 to $116.00.

Additionally, persons who have already submitted applications for registration
to distribute pseudoephedrine, phenylpropanolamine, or combination ephedrine
drug products and paid the $595.00 application fee will receive a refund in the
amount of $479.00.

The second notice is an interim rulemaking amending the regulations to provide
an extension of the application deadline for chemical handlers to December 3,
1997.

Any person who submits an application on or before December 3, 1997, may
continue legitimate business with pseudoephedrine and/or phenylpropanolamine
drug products without a registration pending final action on their application
by DEA.

Internet users can obtain copies of the notices from the government printing
office web site at www.access.gpo.gov.

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                              October 6, 1997

 Questions Received from Industry/Drug Enforcement Administration Responses

The following questions and responses pertain to the general provisions of the
Comprehensive Methamphetamine Control Act of 1996.

Question: If my application to handle ephedrine combination products,
pseudoephedrine, and phenylpropanolamine was filed after the July 12, 1997
deadline, will that adversely effect my ability to handle drug products that
contain pseudoephedrine and phenylpropanolamine?

Answer: No, the regulatory controls of pseudoephedrine and phenylpropanolamine
products do not go into effect until October 3, 1997. DEA will consider your
application on time for those products. The inability to handle ephedrine
combination products is the only restriction imposed because of the missed July
12 deadline. Upon approval of your application, you may resume handling that
product also.

Question: Does a distributor who distributes only pseudoephedrine prescription
products have to register?

Answer: Pursuant to Title 21 Code of Federal Regulations, (21 CFR), Section
1309.28, the requirement for registration is waived for any person who
distributes a prescription drug product containing a List I Chemical that is
already regulated pursuant to (21 CFR) 1300.02(b)(28).

Question: What records are required of a distributor who distributes only
List I prescription drug products?

Answer: The Food and Drug Administration records relating to distribution of
prescription drugs under 21 CFR Part 205 will satisfy DEA's chemical record
requirement.

Question: What constitutes a Suspicious Order and how can Suspicious Orders be
easily recognized?

Answer: The DEA has frequently been asked for guidance on what constitutes a
suspicious order. Repeated below are the items identified in the Chemical
Handlers Manual, pending reprint. This material is useful and will be
supplemented with the results of the work of the Suspicious Orders Task Force
created under the Methamphetamine Control Act.

The reporting of a suspicious order is required by the Controlled Substances Act
and is of primary importance to DEA in limiting the availability of listed
chemicals in the illicit traffic. Each regulated person is most familiar with
its customers and the circumstances surrounding the orders it processes. The
chemical industry must use its best judgment in identifying suspicious orders.
The following are provided in order to assist the industry in identifying
suspicious orders:

1.  An individual who desires to pay cash and wants to pick up the chemical(s).
2.  An established customer who deviates from previous orders or ordering
    methods.
3.  A new customer or unfamiliar representative of an established customer
    who orders listed chemicals.
4.  A customer who has difficulty in pronouncing chemical names.
5.  A customer who is vague about its firm's address, telephone number, and
    reason for desiring a listed chemical.
6.  A customer who wants a listed chemical shipped to a post office box or
    address other than the usual business address.
7.  A customer who prefers to pay by cashier's check, postal money order, etc.
8.  A customer who will not furnish references or who is vague about furnishing
    references for credit purposes.
9.  A customer who desires listed chemicals for reasons at variance with
    accepted legitimate industry practice.
10. A customer who is not a member of a trade, professional, or business
    association.
11. A customer who furnishes false or suspicious addresses, telephone numbers,
    or references.
12. A customer who refuses or is reluctant to establish a credit account or
    provide purchase order information.
13. A customer whose communication either by telephone, mail, or other means is
    not conducted or prepared in a professional business manner.
14. A customer who requests unusual methods or routes of shipment or who
    provides unusual shipping, labeling or packaging instructions.
15. A customer who purchases unusual quantities or combinations of chemicals or
    glassware in contrast with customary practice and usage.
16. A customer whose stated use of listed chemicals is incompatible with
    destination country's commercial activities or consignee's line of business.
17. A customer with little or no business background information available.
18. A customer using a freight forwarder as ultimate consignee.
19. The use of intermediate consignee(s) whose location or business is
    incompatible with the purported end user's nature of business or location.
20. Evasive responses to any questions, or responses that indicate a lack of
    basic knowledge of the industry, or inability to supply information on
    whether listed chemicals are for domestic use or export.

This list is not all inclusive. It is ultimately the responsibility of the
supplier to recognize a suspicious order.

Question: How is a DEA Chemical Registration Control Number constructed?

Answer: The Control Number assigned is unique for each applicant. An
explanation follows.

             CONSTRUCTION OF DEA CHEMICAL REGISTRATION CONTROL NUMBER

The chemical registration control number, which is a temporary number issued
until final registration is approved, has a total of ten characters.

FOR EXAMPLE: CONTROL NUMBER: K22102101E

1:   The first digit is K , which indicates 'chemicals.'
2-4: These numbers indicate the Julian date.
5-7: These are random numbers that are computer generated.
8-9: These are random numbers that are computer generated which indicate the
     number of the each application in a 'batch.'
10:  This is a letter which is a code for the year.

Question: Will the DEA continue to provide case examples or scenarios that may
be encountered as a result of the Comprehensive Methamphetamine Control Act of
1996?

Answer: Presented for your information is an actual case example reported to
DEA. This may be indicative of the type of activities you may encounter. DEA
does not recommend store personnel become engaged in personal confrontation but
that police authorities be notified.

In August 1997, a retail store in the Mid-West reported the theft of
approximately 200 boxes of over-the-counter (OTC) products containing
pseudoephedrine. These thefts took place over several weekends after the store
had re-stocked its shelves on Friday night.

Upon entering the store on the following Mondays, the manager noticed that the
shelf containing OTC pseudoephedrine products was empty. Upon checking the
inventory, she found that none of the boxes (24 and 48 count) of 60 milligram
pseudoephedrine tablets had been purchased. On one weekend, it was noticed by
store staff that these OTC products were gone on Saturday morning.

The store's manager also reported finding a shopping cart near the front of the
store which contained OTC pseudoephedrine products and which had apparently been
abandoned. In another instance, a male who entered the store became very upset
when he found out that the shelves containing these products were empty.

This store has recently removed these products from their shelves, concerned
that if they are placed back on the shelves on Friday night, they will be gone
by Saturday morning. The store manager contacted the regional Loss Prevention
representative in her area, who in turn contacted DEA for guidance.

Due to the distance of this store from the nearest DEA office, the store is
being directed to contact their local law enforcement agency. Furthermore, the
regional Loss Prevention manager also mentioned installing 24 hour surveillance
cameras in an effort to identify the perpetrators involved.

   Questions Received from Industry/Drug Enforcement Administration Responses

The purpose of this summary is to report recent questions from industry
representatives that were not addressed in DEA general guidance
questions/answers. It is our intention to provide summaries periodically in
order to assist industry in complying with legislation. The following questions
and responses pertain to the general provisions of the Comprehensive
Methamphetamine Control Act of 1996.

Question: Will DEA provide a pseudoephedrine/methamphetamine "notice" for
voluntary use by firms which could be included within shipments and inform
distributors about the need to monitor products which may be diverted to
clandestine laboratories?

Answer:
                                     NOTICE

       Important Information to Manufacturers, Distributors and Retailers
          of OTC Pseudoephedrine and Phenylpropanolamine Drug Products

Law enforcement authorities nationwide are witnessing an alarming increase in
the illicit production and use of methamphetamine using OTC pseudoephedrine and
phenylpropanolamine (PPA) drug products. Despite increased domestic and
international enforcement actions that have reduced the availability of bulk
ephedrine and pseudoephedrine, clandestine laboratory operators have responded
by using OTC pseudoephedrine and PPA drug products.

The Drug Enforcement Administration (DEA) and law enforcement authorities wish
to bring to your attention that drug products containing pseudoephedrine and PPA
are List I Chemicals under Federal Law. These chemicals are used in the
manufacturing of cough, cold and allergy products. Anyone who manufactures,
imports, exports or distributes (including selling to the consumer) a listed
chemical is considered a "regulated person". Any person who possesses or
distributes a listed chemical knowing, or having reasonable cause to believe
that it will be used to manufacture a controlled substance, shall be fined, or
imprisoned not more than 10 years, or both. (The law provides for an imprisoned
term of not more than 20 years when the listed chemical is used in the
manufacture of methamphetamine.) The law becomes effective on October 3, 1997.

DEA is seeking voluntary cooperation by industry to reduce the diversion of
these OTC products. More specific information regarding this issue may be
obtained from your local DEA office.

Question: How is a DEA chemical registration number constructed? How does this
differ from the registration number for controlled substances?

Answer:

              CONSTRUCTION OF DEA CHEMICAL REGISTRATION NUMBER

A DEA chemical registration number is easily distinguished from a controlled
substance number.

The chemical registration has a total of nine characters.

1-6: Its first six are numbers, followed by
7:   Alpha (First alpha in the registrant name), followed by
8:   Alpha (random letter), followed by
9:   alpha (Alpha letter that identifies the activity of the chemical
     registrant.



1       Numerical
2          -"-
3          -"-
4          -"-
5          -"-
6          -"-
7       Alpha - First letter in registrant's name
8       Alpha - Random letter
9       Alpha - Letter code that identifies the chemical activity


                                  Example

                          Codes for Ninth Character

                   W       -       Manufacturer (for distribution)
                   Y       -       Distributor
                   V       -       Retail Distributor
                   X       -       Importer
                   Z       -       Exporter

Note: There is no check numeric digit like a controlled substance number.

Question: If an unregistered company repackages List I Chemicals for a
registered company for distribution to the registered company's customers, does
the repackaging company need to be registered?

Answer: If the repackaging company, acting as the agent of the registered
company, returns the repackaged List I Chemicals to the supplying registered
company, with no other distribution of the List I Chemicals by the repackaging
company, then, per 21 CFR 1309.24, the requirement of registration is waived for
the repackaging company, provided that the repackaging company is acting in the
usual course of its business or employment. If the repackaged List I Chemicals
are distributed to customers from the repackaging facility and/or the
repackaging facility takes orders for the List I Chemicals, then a registration
would be required at the repackaging facility.

Question: Can an applicant who distributes ephedrine, pseudoephedrine and/or
phenylpropanolamine products register at his/her residence but store the
products at an unregistered off-site warehouse or storage locker, etc?

Answer: 21 CFR 1309.71 requires that all applicants and registrants provide
effective controls and procedures to guard against theft and diversion of List I
Chemicals. Storage of ephedrine, pseudoephedrine and/or phenylpropanolamine
products at an unregistered off-site location such as a warehouse or storage
locker would be allowed provided that the products are securely locked up at the
off-site facility and that access to the products is limited to the registrant.
Also, the List I Chemicals would have to be returned to the registered location
for distribution to customers.

Question: Can a chart be developed to assist in simplifying and clarifying
compliance with the Methamphetamine Control Act?

Answer: Charts relating to Retail Distributors, Distributors, Wholesale
Distributors, and Importers/Exporters follow.

    Retail Distributors of Ephedrine/Pseudoephedrine/Phenylpropanolamine

                      Effective  Registration  Transaction    Records        Reports
                      Date                     Limit

                                                0 Threshold
                                                   as of
 Single Entity                       YES         11/10/94          YES
                      4/17/94                                                 YES
 Ephedrine                          for all         All          for all
                                 transactions                 transactions
                                                transactions
                                               are regulated

 Combination                         YES             24            YES
                      10/3/96                   grams/single                  YES
 Ephedrine                        if greater    transaction     if greater
                                 than 24 grams                than 24 grams

 Pseudoephedrine

 Ordinary OTC
                        N/A         EXEMPT        EXEMPT         EXEMPT      EXEMPT
 (Blister pack and

 <3 grams/pack)

 Pseudoephedrine

 Other than Ordinary
 OTC                                 YES             24            YES
                      10/3/97                   grams/single                   YES
 (Non-blister pack                if greater    transaction     if greater
 or                              than 24 grams                than 24 grams

 >3 grams/pack)

 Phenylpropanolamine

 Ordinary OTC
                        N/A         EXEMPT        EXEMPT         EXEMPT      EXEMPT
 (Blister pack and

 <3 grams/pack)

 Phenylpropanolamine

 Other than Ordinary
 OTC                                 YES             24            YES
                      10/3/97                   grams/single                   YES
 (Non-blister pack                if greater    transaction     if greater
 or                              than 24 grams                than 24 grams

 >3 grams/pack)

This publication is intended to serve only as general guidance. For information
on the specific requirements of the MCA consult

Public Law P.L. 104-237.

         Distributors who report per 21 USC 830 (b)(3) (Mail Orders) of
                 Ephedrine/Pseudoephedrine/Phenylpropanolamine

                      Effective  Registration  Transaction    Records        Reports
                      Date                     Limit

                                                0 Threshold
                                                   as of
 Single Entity                       YES         11/10/94          YES
                      4/17/94                                                 YES
 Ephedrine                          for all         All          for all
                                 transactions                 transactions
                                                transactions
                                               are regulated

 Combination                         YES             24            YES
                      10/3/96                   grams/single                  YES
 Ephedrine                          for all     transaction     if greater
                                 transactions                 than 24 grams

 Pseudoephedrine

 Ordinary OTC                        YES             24            YES
                      10/3/97                   grams/single                  YES
 (Blister pack and                  for all     transaction     if greater
                                 transactions                 than 24 grams
 <3 grams/pack)

 Pseudoephedrine

 Other than Ordinary
 OTC                                 YES             24            YES
                      10/3/97                   grams/single                   YES
 (Non-blister pack                  for all     transaction     if greater
 or                              transactions                 than 24 grams

 >3 grams/pack)

 Phenylpropanolamine

 Ordinary OTC                        YES             24            YES
                      10/3/97                   grams/single                   YES
 (Blister pack and                  for all     transaction     if greater
                                 transactions                 than 24 grams
 <3 grams/pack)

 Phenylpropanolamine

 Other than Ordinary
 OTC                                 YES             24            YES
                      10/3/97                   grams/single                   YES
 (Non-blister pack                  for all     transaction     if greater
 or                              transactions                 than 24 grams

 >3 grams/pack)

This publication is intended to serve only as general guidance. For
information on the specific requirements of the MCA consult

Public Law P.L. 104-237.

   Wholesale Distributors of Ephedrine/Pseudoephedrine/Phenylpropanolamine

                      Effective  Registration  Transaction       Records        Reports
                      Date                     Limit

                                                0 Threshold as
 Single Entity                       YES         of 11/10/94          YES
                      4/17/94                                                    YES
 Ephedrine                          for all    All transactions     for all
                                 transactions                    transactions
                                                are regulated

 Combination                         YES                              YES
                      10/3/96                          1                         YES
 Ephedrine                          for all    kilo-cumulative     if greater
                                 transactions                     than 1 kilo

 Pseudoephedrine

 Ordinary OTC                        YES                              YES
                      10/3/97                          1                         YES
 (Blister pack and                  for all    kilo-cumulative     if greater
                                 transactions                     than 1 kilo
 <3 grams/pack)

 Pseudoephedrine

 Other than Ordinary
 OTC                                 YES                              YES
                      10/3/97                          1                          YES
 (Non-blister pack                  for all     kilo-cumulative    if greater
 or                              transactions                     than 1 kilo

 >3 grams/pack)

 Phenylpropanolamine
                                                                      YES
 Ordinary OTC                        YES
                      10/3/97                         2.5          if greater     YES
 (Blister pack and                  for all    kilo-cumulative      than 2.5
                                 transactions
                                                                     kilos
 <3 grams/pack)

 Phenylpropanolamine

 Other than Ordinary                                                  YES
 OTC                                 YES
                      10/3/97                         2.5          if greater     YES
 (Non-blister pack                  for all    kilo-cumulative      than 2.5
 or                              transactions                        kilos

 >3 grams/pack)

This publication is intended to serve only as general guidance. For
information on the specific requirements of the MCA consult

Public Law P.L. 104-237.

    Importers/Exporters of Ephedrine/Pseudoephedrine/Phenylpropanolamine

                      Effective  Registration  Transaction       Records        Reports
                      Date                     Limit

                                                0 Threshold as
 Single Entity                       YES         of 11/10/94          YES
                      4/17/94                                                    YES
 Ephedrine                          for all    All transactions     for all
                                 transactions                    transactions
                                                are regulated

 Combination                         YES                              YES
                      10/3/96                          1                         YES
 Ephedrine                          for all    kilo-cumulative     if greater
                                 transactions                     than 1 kilo

 Pseudoephedrine

 Ordinary OTC                        YES                              YES
                      10/3/97                          1                         YES
 (Blister pack and                  for all    kilo-cumulative     if greater
                                 transactions                     than 1 kilo
 <3 grams/pack)

 Pseudoephedrine

 Other than Ordinary
 OTC                                 YES                              YES
                      10/3/97                          1                          YES
 (Non-blister pack                  for all    kilo-cumulative     if greater
 or                              transactions                     than 1 kilo

 >3 grams/pack)

 Phenylpropanolamine
                                                                      YES
 Ordinary OTC                        YES
                      10/3/97                         2.5          if greater     YES
 (Blister pack and                  for all    kilo-cumulative      than 2.5
                                 transactions
                                                                     kilos
 <3 grams/pack)

 Phenylpropanolamine

 Other than Ordinary                                                  YES
 OTC                                 YES
                      10/3/97                         2.5          if greater     YES
 (Non-blister pack                  for all    kilo-cumulative      than 2.5
 or                              transactions                        kilos

 >3 grams/pack)

This publication is intended to serve only as general guidance. For
information on the specific requirements of the MCA consult

Public Law P.L. 104-237.

Question: What is the procedure for obtaining status of an application for
chemical registration?

Answer: There is generally no need to be concerned about the application status.
Each application submitted during the exemption period allows those business
activities applied for to continue uninterrupted until notified differently by
DEA. Refer to Federal Register, May 21, 1997, No 98 ( 62 FR 27693). If an
applicant has reason to need information about the status of a chemical
application, the applicant should contact their local DEA office and ask to
speak with a Diversion Investigator who will assist them.

Question: Can the DEA provide case examples or scenarios that may be encountered
as a result of the Comprehensive Methamphetamine Control Act of 1996?

Answer: Presented for your information are two actual case examples reported to
DEA. These may be indicative of the type of activities you may encounter. DEA
does not recommend store personnel become engaged in personal confrontation but
that police authorities be notified.

1) In June 1997, a female customer entered a retail store in a western state to
purchase 100 count bottles of pseudoephedrine OTC product, specifically
requesting a well known brand name. Due to previous diversion issues with such
products, this retail store had placed them on the shelves directly in front of
the pharmacy counter under the observation of the pharmacy's staff.

After the customer inquired where these products were kept, the pharmacy
technician noticed that the customer had loaded all shelf stock 100 count
bottles into her shopping cart, along with blister packages and the plastic
display cases. When the customer approached the pharmacy's register, she was
advised that she could only purchase five (5) of any of the packages she had in
her cart.

The customer chose 5 x 100 count bottles containing 30 mg pseudoephedrine tabs.

The pharmacist then asked for the customer's identification and copied the
information down from her driver's license. A follow-up investigation by law
enforcement revealed that this female had recently purchased several other
chemicals (such as iodine crystals) used in the illicit manufacture of
methamphetamine.

2) In June 1997, a male stole 3 x 100 count bottles of OTC pseudoephedrine
tablets from a retail store in a western state. Pharmacy employees reported that
they had noticed this man, accompanied by a woman whose membership card was used
to gain entrance into the store, came in every other day, individually or
together, and purchased 100 count bottles of pseudoephedrine. The store's Loss
Prevention Manager followed the couple to their car and asked to see the man's
store card. When the man produced his companion's card, the manager confiscated
it and later turned their license plate number over to law enforcement. The
couple had previous records involving drug trafficking.

Question: Do firms that are reporting mail order transactions have to report
sales that are below the threshold for the product?

Answer: Yes, the Comprehensive Methamphetamine Control Act of 1996, Section 402,
states the following:

"(A) Mail order reporting... Each regulated person who engages in a transaction
     with a nonregulated person which

(I)     involves ephedrine, pseudoephedrine, or phenylpropanolamine (including
        drug products containing these chemicals); and

(II)    Uses or attempts to use the Postal Service or any private or commercial
        carrier shall, on a monthly basis, submit a report of each such
        transaction conducted during the previous month to the Attorney General
        in such form, containing such data."

(B) The data required for such report shall include:

"(I)    The name of the purchaser,

(II)    The quantity and form of the chemical [ephedrine, pseudoephedrine, or
        phenylpropanolamine] purchased, and

(III)   The address to which the chemical [ephedrine, pseudoephedrine, or
        phenylpropanolamine] was sent."

While not required at this time, the date of each transaction, the trade name,
and the lot number of the product distributed (where applicable) are requested.

Reports should be mailed to:

Drug Enforcement Administration
Office of Diversion Control
Domestic Chemical Operations Section (ODCD)
Washington, D.C. 20537

Mail order reporting guidelines were published in the Federal Register, February
7, 1997, No 26 (62 FR 5851).

Question: Are retail outlets required to be registered with the DEA to handle
ephedrine combination products?

Answer: Retail registration is waived under certain conditions. The Code of
Federal Regulations, 21 CFR 1309.29 states:

"The requirement of registration is waived for any retail distributor whose
activities with respect to List I Chemicals are restricted to the distribution
of below threshold quantities of a combination ephedrine drug product in a
single transaction to an individual for legitimate medical use. The threshold
for a distribution of a combination ephedrine drug product in a single
transaction to an individual for legitimate medical use is 24 grams of ephedrine
base."

Issue: Many large distributors of controlled substances have for a number of
years used the registration database to help ensure that those substances are
distributed only to authorized persons. A similar application for verifying the
registration of chemical registrants would be helpful for the purposes of
verifying DEA Registrations issued to Manufacturers, Distributors, Importers,
and Exporters of List 1 Chemicals:

Question: Are these classes of registrants currently included in the master
listing of DEA Controlled Substance registrants which is distributed through the
National Technical Information Service (NTIS)?

Answer: No, not at present.

Question: If not, is a separate listing of List 1 Chemical Registrants available
through the NTIS, DEA, or any other source?

Answer: No, not at present.

Question: Would the DEA consider exploring ways to make such list available to
industry, perhaps on a limited basis?

Answer: Yes, this issue is being addressed by DEA's Office of Domestic Chemical
Operations (ODCD). ODCD is in the process of working with NTIS to provide a
separate listing of List I Chemical Registrants. ODCD will also request that
List I Chemical Registrants be included on the master listing of DEA Controlled
Substance Registrants because some CSA registrants handle controlled substances
and List I Chemicals, and they are not required to obtain a separate chemical
registration. DEA is also seeking legal counsel regarding the use of the DEA
Internet Home Page to facilitate making this information available to authorized
inquiries.

Question: On the Application for Chemical Registration, DEA Form 510, which
Business Activity category should be checked in question number one if the
business is classified as a "Wholesaler?"

Answer: Distributor, because, according to 21 CFR 1300.02 (a)(29), "The term
retail distributor means a grocery store, general merchandise store, drug store,
or other entity or person whose activities as a distributor relating to drug
products containing pseudoephedrine, phenylpropanolamine, or ephedrine are
limited almost exclusively to sales for personal use, both in number of sales
and volume of sales, either directly to walk-in customers or in face-to-face
transactions by direct sales. For the purposes of this paragraph, sale for
personal use means the distribution of below-threshold quantities in a single
transaction to an individual for legitimate medical use." If a firm's activities
do not meet this definition, then they are a "Distributor."

Question: Will DEA issue a chemical registration to a Post Office Box?

Answer: No. 21 USC 822 (2)(e) states the following, "A separate registration
shall be required at each principal place of business or professional practice
where the applicant manufactures, distributes, or dispenses controlled
substances or List I Chemicals."

A registrant may include a Post Office Box in addition to the physical location
where the activities are carried out. Therefore, the registration must reflect
the location from which the chemicals are distributed, imported, or exported.

Question: At Distribution Centers, does DEA consider it suspicious and,
therefore, require notification each time the cumulative threshold of one
kilogram for pseudoephedrine and 2 1/2 kilograms for phenylpropanolamine
products are reached in a calendar month?

Answer: Not necessarily, the threshold establishes the point at which the
recordkeeping and reporting requirements apply to a transaction. There is no
automatic suspicion attached to reaching the threshold. Other factors must be
considered such as what has been normal prior sales history for this customer?
Is it a large scale distributor? The totality of elements surrounding the
transaction should be considered in making such a determination.

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