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Chemical Program
> Mail Order Reporting Process
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
Each regulated person who
engages in a transaction with a non-regulated party (a consumer or
end-user who does not re-distribute) which involves ephedrine,
pseudoephedrine, phenylpropanolamine (including drug products containing these
chemicals) via postal service, private carrier, is required to submit a
monthly report of all such transactions regardless of the size of the
transaction.
The reports must include the
name of the purchaser; the quantity and form of the ephedrine,
pseudoephedrine, or phenylpropanolamine purchased; the date of each
transaction; the address to which the product was sent; and such other
items of information which DEA may by regulation require. Reports should
be sent to the Chemical Control Section, Office of Diversion Control, Drug
Enforcement Administration, Washington, D.C. 20537. Regulated person
should check with DEA for the latest requirements.
The following distributions of
drug products to non-regulated persons are exempted from the mail order
reporting requirements:
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Distributions of sample
packages of drug products when those packages contain not more than
two solid dosage units or the equivalent of two dosage units in liquid
form, not to exceed 10 milliliters of liquid per package, and not more
than one package is distributed to an individual or residential
address in any 30-day period.
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Distributions by retail
distributors that may not include face-to-face transactions, to the
extent that such distributions are consistent with the activities of a
retail distributor.
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Distributions to a
resident of a long term care facility, or to a long term care facility
for dispensing to or use by a resident of that facility.
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Distributions in
accordance with a valid prescription.
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Exports which have been
reported to DEA under the transshipment reporting requirements (21
CFR 1313.31), or the international transaction reporting
requirements (21 CFR 1313.32),
or for which advance notification reporting requirements are waived (21
CFR 1313.21)
DEA may revoke exemptions for
regulated persons whose distributions are found to violate regulations.
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