[Federal Register Volume 62, Number 26 (Friday, February 7, 1997)]
[Notices]
[Pages 5851-5852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3085]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA Number 155N]
Reports of Certain Distributions by Postal Service or Private or
Commercial Carriers to Nonregulated Persons
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice; guidance.
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SUMMARY: This notice provides temporary guidance to persons who
distribute ephedrine, pseudoephedrine, and phenylpropanolamine,
including drug products containing those chemicals, to nonregulated
persons by either the Postal Service or private or commercial carriers.
The comprehensive Methamphetamine Control Act of 1996 requires that, as
of October 3, 1996, any person who engages in the above distributions
must make a monthly report of each such transaction to the Attorney
General in such a manner as the Attorney General shall establish by
regulation. This notice provides temporary guidance that will allow
affected persons to comply with the new reporting requirements pending
promulgation of the appropriate regulations.
FOR FURTHER INFORMATION CONTACT: William Wolf, Jr., Chief, Chemical
Operations Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, D.C. 20537, Telephone (202) 307-7204.
SUPPLEMENTARY INFORMATION: On October 3, 1996, the Comprehensive
Methamphetamine Control Act of 1996 (MCA) was signed into law. Section
402 of the MCA requires that ``(A) Each regulated person who engages in
a transaction with a nonregulated person which--(i) involves ephedrine,
pseudoephedrine, or
[[Page 5852]]
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, and at such
times as the Attorney General shall establish by regulation.'' Section
402 further requires that such reports shall include the name of the
purchaser, the quantity and form of the chemical purchased, and the
address to which the chemical was sent. The reporting requirement
became effective on October 3, 1996, and applies to all transactions
after that date.
While the term nonregulated person is not specifically defined, the
term regulated person is defined as ``* * * a person who manufactures,
distributes, imports, or exports a listed chemical, a tableting
machine, or an encapsulating machine or who acts as a broker or trader
for an international transaction involving a listed chemical, a
tableting machine, or an encapsulating machine.'' See 21 U.S.C.
802(38). Any reference to a listed chemical in the statute includes a
drug product containing any listed chemical, whether or not that drug
product is exempt from any requirement under the law. A nonregulated
person, therefore, is a person who does not manufacture, distribute,
import, or export a product containing a listed chemical, or a
tableting or encapsulating machine or who does not act as a broker or
trader for an international transaction involving a product that
contains a listed chemical or for a tableting or encapsulating machine.
Pending proposal and promulgation of final regulations establishing
the specific procedures to be followed in making the reports, persons
engaged in the distribution of ephedrine, pseudoephedrine, and
phenylpropanolamine (including drug products containing those
chemicals) to nonregulated persons by mail or private or commercial
carrier are requested to satisfy the reporting requirement by
submitting the reports by no later than the 15th day of the succeeding
month to the Chemical Operations Section, Office of Diversion Control,
Drug Enforcement Administration, Washington, D.C. 20537, Attn: Section
402 Reports.
As established by the MCA, each report must contain the name of the
purchaser, the quantity and form of the ephedrine, pseudoephedrine, or
phenylpropanolamine purchased, and the address to which the chemical
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.
As noted earlier, the reporting requirement applies only to
distributions of ephedrine, pseudoephedrine, and phenylpropanolamine
via the postal service or private or commercial carrier to nonregulated
persons. A distributor does not have to report distributions to
regulated persons. In this regard, it is critical that distributors
take the appropriate steps to ascertain whether their customers are
regulated or nonregulated persons. The failure of a distributor to
report a transaction based on a customer's mere representation that
they are a regulated person, without further inquiry to confirm that
status, may be grounds for administrative, civil, or criminal action.
Therefore, the distributor should take appropriate steps to confirm the
customer's status as a regulated person. Steps may include verification
of the customer's DEA registration status or, if they are not a
registrant, inquiry as to whether they are in the business of
redistributing the products ordered.
The above guidelines are intended to provide affected persons with
a temporary means to ensure compliance with the reporting requirement
set out in section 402 of the MCA, pending promulgation of final
regulations, through notice and comment, regarding the reporting
requirement. DEA will publish a notice of proposed rulemaking in the
near future detailing the proposed amendments to the regulations in
Title 21, Code of Federal Regulations, part 1310, to establish the
specific reporting requirements to be followed.
Any questions regarding the reporting requirement set out in
section 402 of the MCA should be directed to the Chemical Operations
Section, Office of Diversion Control, Drug Enforcement Administration,
Washington, D.C. 20537, telephone (202) 307-7204.
DEA is preparing the appropriate documentation regarding the new
reporting requirement established by the MCA for submission to the
Office of Management and Budget for review, pursuant to the provisions
of the Paperwork Reduction Act of 1980, 44 U.S.C., Chapter 35.
Dated: January 30, 1997.
Gene R. Haislip,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 97-3085 Filed 2-6-97; 8:45 am]
BILLING CODE 4410-09-M
