21 C.F.R. § 1309.24 Waiver of registration requirement for certain activities.
Title 21 - Food and Drugs
(a) The requirement of registration is waived for any agent or employee of a person who is registered to engage in any group of independent activities, if such agent or employee is acting in the usual course of his or her business or employment. (b) The requirement of registration is waived for any person who distributes a product containing a List I chemical that is regulated pursuant to §1300.02(b)(28)(i)(D), if that person is registered with the Administration to manufacture, distribute or dispense a controlled substance. (c) The requirement of registration is waived for any person who imports or exports a product containing a List I chemical that is regulated pursuant to §1300.02(b)(28)(i)(D), if that person is registered with the Administration to engage in the same activity with a controlled substance. (d) The requirement of registration is waived for any person who distributes a prescription drug product containing a List I chemical that is regulated pursuant to §1300.02(b)(28)(i)(D) of this chapter. (e) The requirement of registration is waived for any retail distributor whose activities with respect to List I chemicals are limited to the distribution of below-threshold quantities of a pseudoephedrine, phenylpropanolamine, or combination ephedrine product that is regulated pursuant to §1300.02(b)(28)(i)(D) of this chapter, in a single transaction to an individual for legitimate medical use, irrespective of whether the form of packaging of the product meets the definition of “ordinary over-the-counter pseudoephedrine or phenylpropanolamine product” under §1300.02(b)(31) of this chapter. (f) The requirement of registration is waived for any person whose activities with respect to List I chemicals are limited to the distribution of red phosphorus, white phosphorus, or hypophosphorous acid (and its salts) to: another location operated by the same firm solely for internal end-use; or an EPA or State licensed waste treatment or disposal firm for the purpose of waste disposal. (g) The requirement of registration is waived for any person whose distribution of red phosphorus or white phosphorus is limited solely to residual quantities of chemical returned to the producer, in reusable rail cars and intermodal tank containers which conform to International Standards Organization specifications (with capacities greater than or equal to 2,500 gallons in a single container). (h) The requirement of registration is waived for any manufacturer of a List I chemical, if that chemical is produced solely for internal consumption by the manufacturer and there is no subsequent distribution or exportation of the List I chemical. (i) If any person exempted under paragraph (b), (c), (d), (e), (f) or (g) of this section also engages in the distribution, importation or exportation of a List I chemical, other than as described in such paragraph, the person shall obtain a registration for such activities, as required by §1309.21 of this part. (j) The Administrator may, upon finding that continuation of the waiver would not be in the public interest, suspend or revoke a waiver granted under paragraph (b), (c), (d), (e), (f) or (g) of this section pursuant to the procedures set forth in §§1309.43 through 1309.46 and 1309.51 through 1309.55 of this part. In considering the revocation or suspension of a person's waiver granted pursuant to paragraph (b) or (c) of this section, the Administrator shall also consider whether action to revoke or suspend the person's controlled substance registration pursuant to 21 U.S.C. 824 is warranted. (k) Any person exempted from the registration requirement under this section shall comply with the security requirements set forth in §§1309.71–1309.73 of this part and the recordkeeping and reporting requirements set forth under parts 1310 and 1313 of this chapter. [67 FR 14860, Mar. 28, 2002, as amended at 68 FR 37414, June 24, 2003; 68 FR 57803, Oct. 7, 2003]
Title 21: Food and Drugs
PART 1309—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS
Requirements for Registration
§ 1309.24 Waiver of registration requirement for certain activities.
