21 CFR 1310.03 - Persons required to keep records and file reports.

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There are 2 Updates appearing in the Federal Register for 21 CFR Part 1310. View below or at eCFR (GPOAccess)
§ 1310.03 Persons required to keep records and file reports.
Link to an amendment published at 81 FR 97022, December 30, 2016.
Link to a delay published at 82 FR 8688, Jan. 30, 2017.

(a) Each regulated person who engages in a regulated transaction involving a listed chemical, a tableting machine, or an encapsulating machine shall keep a record of the transaction as specified by § 1310.04 and file reports as specified by § 1310.05. However, a non-regulated person who acquires listed chemicals for internal consumption or “end use” and becomes a regulated person by virtue of infrequent or rare distribution of a listed chemical from inventory, shall not be required to maintain receipt records of listed chemicals under this section.

(b) Each regulated person who manufactures a List I or List II chemical shall file reports regarding such manufacture as specified in Section 1310.05.

(c) Each regulated person who engages in a transaction with a nonregulated 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 Postal Service or any private or commercial carrier must file monthly reports of each such transaction as specified in § 1310.05 of this part.

[ 54 FR 31665, Aug. 1, 1989, as amended at 56 FR 8277, Feb. 28, 1991; 61 FR 14023, Mar. 29, 1996; 67 FR 14861, Mar. 28, 2002; 68 FR 57804, Oct. 7, 2003; 70 FR 294, Jan. 4, 2005]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code

Title 21 published on 2015-12-03

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 1310 after this date.

  • 2017-01-30; vol. 82 # 18 - Monday, January 30, 2017
    1. 82 FR 8688 - Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes To Implement the International Trade Data System (ITDS); Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments
      GPO FDSys XML | Text
      DEPARTMENT OF JUSTICE, Drug Enforcement Administration
      Final rule; delay of effective date.
      Effective Dates: This Final Rule is effective January 30, 2017. The effective date of the Final Rule amending 21 CFR parts 1300, 1301, 1302, 1303, 1304, 1308, 1309, 1310, 1312, 1313, 1314, 1315, 1316, and 1321 published in the Federal Register December 30, 2016, at 81 FR 96992 is delayed to March 21, 2017. However, compliance with the revisions to DEA regulations made by this rule is not required until July 31, 2017.
      21 CFR Parts 1300, 1301, 1302, 1303, 1304, 1308, 1309, 1310, 1312, 1313, 1314, 1315, 1316, and 1321

Title 21 published on 2015-12-03.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2017-01-30; vol. 82 # 18 - Monday, January 30, 2017
    1. 82 FR 8688 - Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes To Implement the International Trade Data System (ITDS); Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments
      GPO FDSys: XML | Text
      DEPARTMENT OF JUSTICE, Drug Enforcement Administration
      Final rule; delay of effective date.
      Effective Dates: This Final Rule is effective January 30, 2017. The effective date of the Final Rule amending 21 CFR parts 1300, 1301, 1302, 1303, 1304, 1308, 1309, 1310, 1312, 1313, 1314, 1315, 1316, and 1321 published in the Federal Register December 30, 2016, at 81 FR 96992 is delayed to March 21, 2017. However, compliance with the revisions to DEA regulations made by this rule is not required until July 31, 2017.
      21 CFR Parts 1300, 1301, 1302, 1303, 1304, 1308, 1309, 1310, 1312, 1313, 1314, 1315, 1316, and 1321