21 CFR 1310.06 - Content of records and reports.

§ 1310.06 Content of records and reports.
(a) Each record required by § 1310.03 shall include the following:
(1) The name, address, and, if required, DEA registration number of each party to the regulated transaction.
(2) The date of the regulated transaction.
(3) The name, quantity and form of packaging of the listed chemical or a description of the tableting machine or encapsulating machine (including make, model and serial number).
(4) The method of transfer (company truck, picked up by customer, etc.).
(5) The type of identification used by the purchaser and any unique number on that identification.
(b) For purposes of this section, normal business records shall be considered adequate if they contain the information listed in paragraph (a) of this section and are readily retrievable from other business records of the regulated person. For prescription drug products, prescription and hospital records kept in the normal course of medical treatment shall be considered adequate for satisfying the requirements of paragraph (a) of this section with respect to dispensing to patients, and records required to be maintained pursuant to the Federal Food and Drug Administration regulations relating to the distribution of prescription drugs, as set forth in 21 CFR part 205, shall be considered adequate for satisfying the requirements of paragraph (a) of this section with respect to distributions.
(c) Each report required by Section 1310.05(a) shall include the information as specified by Section 1310.06(a) and, where obtainable, the registration number of the other party, if such party is registered. A report submitted pursuant to § 1310.05(a)(1) or (a)(4) must also include a description of the circumstances leading the regulated person to make the report, such as the reason that the method of payment was uncommon or the loss unusual. If the report is for a loss or disappearance under § 1310.05(a)(4), the circumstances of such loss must be provided (in-transit, theft from premises, etc.)
(d) A suggested format for the reports is provided below:
Supplier:
Registration Number
Name
Business Address
City
State
Zip
Business Phone
Purchaser:
Registration Number
Name
Business Address
City
State
Zip
Business Phone
Identification
Shipping Address (if different than purchaser Address):
Street
City
State
Zip
Date of Shipment
Name of Listed Chemical(s)
Quantity and Form of Packaging
Description of Machine:
Make
Model
Serial #
Method of Transfer
If Loss or Disappearance:
Date of Loss
Type of Loss
Description of Circumstances
(e) Each report of an importation of a tableting machine or an encapsulating machine required by § 1310.05(c) shall include the following information:
(1) The name, address, telephone number, and, where available, the facsimile number of the regulated person; the name, address, telephone number, and, where available, the facsimile number of the import broker or forwarding agent, if any:
(2) The description of each machine (including make, model, and serial number) and the number of machines being received;
(3) The proposed import date, and the first U.S. Customs Port of Entry; and
(4) The name, address, telephone number, and, where available, the facsimile number of the consignor in the foreign country of exportation.
(f) Each report of an exportation of a tableting machine or an encapsulating machine required by § 1310.05(c) shall include the following information:
(1) The name, address, telephone number, and, where available, the facsimile number of the regulated person; the name, address, telephone number, and, where available, the facsimile number of the export broker, if any:
(2) The description of each machine (including make, model, and serial number) and the number of machines being shipped;
(3) The proposed export date, the U.S. Customs Port of exportation, and the foreign Port of Entry; and
(4) The name, address, telephone number, and, where available, the facsimile number of the consignee in the country where the shipment is destined; the name(s) and address(es) of any intermediate consignee(s).
(g) Declared exports of machines which are refused, rejected, or otherwise deemed undeliverable may be returned to the U.S. exporter of record. A brief written report outlining the circumstances must be sent to the Import/Export Unit, Drug Enforcement Administration, following the return within a reasonable time. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. This provision does not apply to shipments that have cleared foreign customs, been delivered, and accepted by the foreign consignee. Returns to third parties in the United States will be regarded as imports.
(h) Each annual report required by Section 1310.05(d) shall provide the following information for each listed chemical manufactured:
(1) The name, address and chemical registration number (if any) of the manufacturer and person to contact for information.
(2) The aggregate quantity of each listed chemical that the company manufactured during the preceding calendar year.
(3) The year-end inventory of each listed chemical as of the close of business on the 31st day of December of each year. (For each listed chemical, if the prior period's ending inventory has not previously been reported to DEA, this report should also detail the beginning inventory for the period.) For purposes of this requirement, inventory shall reflect the quantity of listed chemicals, whether in bulk or non-exempt product form, held in storage for later distribution. Inventory does not include waste material for destruction, material stored as an in-process intermediate or other in-process material.
(4) The aggregate quantity of each listed chemical used for internal consumption during the preceding calendar year, unless the chemical is produced solely for internal consumption.
(5) The aggregate quantity of each listed chemical manufactured which becomes a component of a product exempted from paragraphs (1)(iv) or (1)(v) of the definition of regulated transaction in § 1300.02 of this chapter during the preceding calendar year.
(6) Data shall identify the specific isomer, salt or ester when applicable but quantitative data shall be reported as anhydrous base or acid in kilogram units of measure.
(i) Each monthly report required by § 1310.05(e) of this part shall 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., 30mg, 60mg, 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).
(j) Information provided in reports required by § 1310.05(e) of this part which is exempt from disclosure under section 552(a) of Title 5, by reason of section 552(b)(6) of Title 5, will be provided the same protections from disclosure as are provided in section 310(c) of the Act (21 U.S.C. 830(c)) for confidential business information.
[54 FR 31665, Aug. 1, 1989, as amended at 57 FR 2462, Jan. 22, 1992; 59 FR 51364, Oct. 11, 1994; 60 FR 32461, June 22, 1995; 61 FR 14024, Mar. 29, 1996; 61 FR 32926, June 26, 1996; 67 FR 14862, Mar. 28, 2002; 67 FR 49569, July 31, 2002; 75 FR 10681, Mar. 9, 2010; 77 FR 4236, Jan. 27, 2012]

Title 21 published on 2013-04-01

no entries appear in the Federal Register after this date.

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