21 CFR Parts 1300–1399 · 20 parts · 472 sections · reproduced in full
| Part | Title | What it covers |
|---|---|---|
| 1300 | Definitions 6 sections | Defines key terms like "controlled substance," "manufacturer," "dispenser," and "online pharmacy." |
| 1301 | Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances 50 sections | How to apply for, maintain, and renew a DEA researcher registration. |
| 1302 | Labeling and Packaging Requirements for Controlled Substances 8 sections | How controlled substances must be labeled and packaged for storage and distribution. |
| 1303 | Quotas 25 sections | Annual production limits for Schedule I and II substances. A trial must stay within these quotas. |
| 1304 | Records and Reports of Registrants ★ critical 21 sections | Inventory, recordkeeping, and reporting requirements, including ARCOS. |
| 1305 | Orders for Schedule I and II Controlled Substances ★ critical 26 sections | DEA Form 222 and electronic orders — how Schedule II substances are procured. |
| 1306 | Prescriptions ★ critical 24 sections | Issuance and filling of prescriptions, including the e-prescribing exemption. |
| 1307 | Miscellaneous 10 sections | Administrative provisions, including disposal of controlled substances. |
| 1308 | Schedules of Controlled Substances ★ critical 28 sections | The official list of all controlled substances and their schedules. |
| 1309 | Registration of Manufacturers, Distributors, Importers and Exporters of List I Chemicals 34 sections | Registration for handling precursor chemicals. |
| 1310 | Records and Reports of Listed Chemicals and Certain Machines; Importation and Exportation of Certain Machines 16 sections | Recordkeeping for listed chemicals. |
| 1311 | Requirements for Electronic Orders and Prescriptions ★ critical 36 sections | Technical requirements for electronic prescribing and ordering. |
| 1312 | Importation and Exportation of Controlled Substances 31 sections | Rules for importing or exporting controlled substances. |
| 1313 | Importation and Exportation of List I and List II Chemicals 32 sections | Chemical import/export. |
| 1314 | Retail Sale of Scheduled Listed Chemical Products 23 sections | Over-the-counter sales of certain products. |
| 1315 | Importation and Production Quotas for Ephedrine, Pseudoephedrine, and Phenylpropanolamine 29 sections | Importation and production quotas for specific chemicals. |
| 1316 | Administrative Functions, Practices, and Procedures 49 sections | DEA hearings, inspections, and enforcement actions. |
| 1317 | Disposal ★ critical 16 sections | Procedures for the lawful disposal of controlled substances. |
| 1318 | Controls to Satisfy the Requirements of the Act Applicable to the Manufacturing of Marihuana 7 sections | Marijuana cultivation controls. |
| 1321 | DEA Mailing Addresses 1 section | Official mailing addresses for the DEA. |
| 1322–1399 | [Reserved] | Currently unused and reserved for future regulations. |
★ critical — parts most directly governing a Schedule II clinical trial: procurement (1305), recordkeeping and ARCOS reporting (1304), prescriptions and the e-prescribing exemption (1306, 1311), the schedules themselves (1308), and lawful disposal (1317). Everything is also available on a single page for full-text search.