21 U.S.C. 830 (b) (3) (A) - Reports of Mail Order Distributions

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, Diversion Control Division, 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:

  1. 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.
  2. 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.
  3. 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.
  4. Distributions in accordance with a valid prescription.
  5. 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.

Suggested Reporting Format (MS Excel Format)