[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1309.24]

[Page 103-104]
 
                         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--Table of Contents
 
Sec. 1309.24  Exemption of agents and employees.

    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.

    Effective Date Note: At 67 FR 14860, Mar. 28, 2002, Sec. 1309.24 was 
revised, effective Apr. 29, 2002. For the convenience of the user, the 
revised text follows:

Sec. 1309.24  Waiver of registration requirement for certain activities.

    (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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 1300.02(b)(31) of this chapter. 
The threshold for a distribution of a product in a single transaction to 
an individual for legitimate medical use is 24 grams of pseudoephedrine, 
phenylpropanolamine, or ephedrine base.
    (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 isotainers (with capacities greater than or equal to 2500 
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 Sec. 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),

[[Page 104]]

(e), (f) or (g) of this section pursuant to the procedures set forth in 
Secs. 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 
Secs. 1309.71-1309.73 of this part and the recordkeeping and reporting 
requirements set forth under parts 1310 and 1313 of this chapter.