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Chemical Handler's Manual

SECTION VI – REPORTS TO THE DRUG ENFORCEMENT ADMINISTRATION

What Must be Reported

Information regarding this subject may be found at 21 U.S.C. § 830(b) and 21 C.F.R. § 1310.05.

Each regulated person shall report to the Special Agent in Charge of the local DEA Divisional Office (Appendix P) for the area in which the regulated person making the report is located, as follows:

  1. Any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of the CSA.
  2. Any proposed regulated transaction with a person whose description or other identifying characteristic the DEA has previously furnished to the regulated person.
  3. Any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person. The regulated person responsible for reporting a loss in-transit is the supplier.
  4. Any domestic regulated transaction of a tableting machine or an encapsulating machine. The importation and exportation of these machines are addressed in Section VII.

Each report submitted regarding paragraphs 1 through 4 above shall, whenever possible, be made orally to the local DEA office at the earliest practicable opportunity after the regulated person becomes aware of the circumstances involved and as much in advance of the conclusion of the transaction as possible. Written reports of transactions regarding paragraphs 1, 3, and 4 above, must be filed within 15 days after the regulated person becomes aware of the circumstances of the event. Detailed reporting requirements are found in 21 C.F.R. § 1310.06.

A transaction may not be completed with a person whose description or identifying characteristic has been previously furnished to the regulated person by the DEA unless the transaction is approved by the DEA.

Bulk Manufacturers' Reports

Regulated bulk manufacturers of listed chemicals are required to submit manufacturing, inventory, and use data on an annual basis to:

Drug Enforcement Administration
Attn: Drug and Chemical Evaluation Section/ODE
8701 Morrissette Drive
Springfield, VA 22152

Reports are due by March 15 of the year immediately following the calendar year for which the report is being submitted. Information regarding this subject may be found at 21 C.F.R. §§ 1310.05(d) and 1310.06(h).

Reports of Mail-Order Sales

Information regarding these reports may be found at 21 U.S.C. § 830(b)(3); 21 C.F.R. §§ 1310.03, 1310.05, and 1310.06(i). Other information regarding mail-order sales can be found in Section IX, Retail Sales of Scheduled Listed Chemical Products.

Each regulated person who engages in a transaction with a non-regulated person or who engages in an export transaction that involves ephedrine, pseudoephedrine, phenylpropanolamine, or gamma-hydroxybutyric acid, including drug products containing these chemicals, and uses or attempts to use the U.S. Postal Service or any private or commercial carrier, is required to submit monthly reports of each such transaction.

Each monthly report must provide the following information for each distribution:

  1. Supplier name and registration number;
  2. Purchaser's name and address;
  3. Name/address shipped to (if different from purchaser's name/address);
  4. Name of the chemical and total amount shipped (i.e., pseudoephedrine, 250 grams);
  5. Date of shipment;
  6. Product name (if drug product);
  7. Dosage form (if drug product) (i.e., pill, tablet, liquid);
  8. Dosage strength (if drug product) (i.e., 30 mg, 60 mg, per dose etc.);
  9. Number of dosage units (if drug product) (100 doses per package);
  10. Package type (if drug product) (bottle, blister pack, etc.);
  11. Number of packages (if drug product) (10 bottles);
  12. Lot number (if drug product).

Reports of mail-order sales should be sent to:

Drug Enforcement Administration
Attn: Import/Export Unit/ODGI
8701 Morrissette Drive
Springfield, VA 22152

The written reports must be submitted on or before the 15th day of each month following the month in which the distributions took place. The report shall be submitted under company letterhead, signed by the person authorized to sign the registration or self-certification application on behalf of the regulated person or regulated seller, respectively. If the regulated person or regulated seller is not a DEA registrant, the report should be signed by a company official with similar authority. Upon request to and approval by the DEA, a regulated person may submit this report electronically to the DEA.

Exemptions from Reporting Requirements

Information regarding this subject may be found at 21 C.F.R. §§ 1310.05 and 1314.115.

The following distributions made by regulated persons to non-regulated persons or export transactions that involve ephedrine, pseudoephedrine, phenylpropanolamine, or gamma-hydroxybutyric acid, including drug products containing these chemicals, and use or attempt to use the Postal Service or any private or commercial carrier are exempted from the aforementioned reporting requirements. Exemptions to mail-order sales reporting requirements only apply to paragraphs 1 through 4 below.

  1. Distributions of sample packages when those packages contain no 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 of drug products 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, except that this does not apply to sales of scheduled listed chemical products (SLCP) at retail.
  3. Distributions of drug products to a resident of a long term care facility or distributions to a long term care facility for dispensing to or use by a resident of that facility.
  4. Distributions of drug products pursuant to a valid prescription.
  5. Exports which have been reported to the DEA under the transshipment reporting requirements (21 C.F.R. § 1313.31), or the international transaction reporting requirements (21 C.F.R. § 1313.32), or for which advance notification reporting requirements are waived.

The DEA may revoke exemptions for regulated persons whose distributions of drug products are found to violate the CSA or the regulations.

 

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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Diversion Control Division  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539

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