{"data":{"id":"us/21-cfr-1309.21","jurisdiction":"us","citation":"21 CFR 1309.21","heading":"Persons required to register.","body":"(a) Unless exempted by law or under §§ 1309.24 through 1309.26 or §§ 1310.12 through 1310.13 of this chapter, the following persons must annually obtain a registration specific to the List I chemicals to be handled:\n(1) Every person who manufactures or imports or proposes to manufacture or import a List I chemical or a drug product containing ephedrine, pseudoephedrine, or phenylpropanolamine.\n(2) Every person who distributes or exports or proposes to distribute or export any List I chemical, other than those List I chemicals contained in a product exempted under paragraph (1)(iv) of the definition of regulated transaction in § 1300.02 of this chapter.\n(b) Only persons actually engaged in the activities are required to obtain a registration; related or affiliated persons who are not engaged in the activities are not required to be registered. (For example, a stockholder or parent corporation of a corporation distributing List I chemicals is not required to obtain a registration.)\n(c) The registration requirements are summarized in the following table:\nSummary of Registration Requirements and Limitations\nBusiness activity Chemicals DEA forms Application fee Registration period (years) Coincident activities allowed\n(1) Manufacturing List I, Drug products containing ephedrine, pseudoephedrine, phenylpropanolamine New-510 Renewal-510a 3,699 1 May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered.\n(2) Distributing List I, Scheduled listed chemical products New-510 Renewal-510a 1,850 1\n(3) Importing List I, Drug Products containing ephedrine, pseudoephedrine, phenylpropanolamine New-510 Renewal-510a 1,850 1 May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered.\n(4) Exporting List I, Scheduled listed chemical products New-510 Renewal-510a 1,850 1","path":["Title 21—Food and Drugs","CHAPTER II—DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE","PART 1309—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"9be6f126d7c7653bd997549c686adf7085aa84c7cedebd602bda5e8344936894","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-1309.12","next":"us/21-cfr-1309.22"},"notice":"GroundRules: Original legal text. Not legal advice."}