---
kind: "range"
citation: "21 C.F.R. §§ 1309.43–1309.46"
title: "21"
from: "1309.43"
to: "1309.46"
count: 4
url: "https://uscodex.org/cfr/21/1309.43..1309.46"
---

# §1309.43. Suspension or revocation of registration.

- (a) The Administrator may suspend any registration pursuant to section 304(a) of the Act ([21 U.S.C. 824(a)](/usc/21/824.md?p=a)) for any period of time he determines.
- (b) The Administrator may revoke any registration pursuant to section 304(a) of the Act ([21 U.S.C. 824(a)](/usc/21/824.md?p=a)).
- (c) Before revoking or suspending any registration, the Administrator shall issue an order to show cause pursuant to [Section 1309.46](/cfr/21/1309.46.md) and, if requested by the registrant, shall hold a hearing pursuant to [Section 1309.51](/cfr/21/1309.51.md). Notwithstanding the requirements of this Section, however, the Administrator may suspend any registration pending a final order pursuant to [§ 1309.44](/cfr/21/1309.44.md).
- (d) Upon service of the order of the Administrator suspending or revoking registration, the registrant shall immediately deliver his or her Certificate of Registration to the nearest office of the Administration. Also, upon service of the order of the Administrator revoking or suspending registration, the registrant shall, as instructed by the Administrator:
  - (1) Deliver all List I chemicals in his or her possession that were obtained under the authority of a registration or an exemption from registration granted by the Administrator by regulation, to the nearest office of the Administration or to authorized agents of the Administration; or
  - (2) Place all such List I chemicals in his or her possession under seal as described in section 304(f) of the Act ([21 U.S.C. 824(f)](/usc/21/824.md?p=f)).
- (e) In the event that revocation or suspension is limited to a particular chemical or chemicals, the registrant shall be given a new Certificate of Registration for all substances not affected by such revocation or suspension; no fee shall be required for the new Certificate of Registration. The registrant shall deliver the old Certificate of Registration to the nearest office of the Administration. Also, upon service of the order of the Administrator revoking or suspending registration with respect to a particular chemical or chemicals, the registrant shall, as instructed by the Administrator:
  - (1) Deliver to the nearest office of the Administration or to authorized agents of the Administration all of the particular chemical or chemicals in his or her possession that were obtained under the authority of a registration or an exemption from registration granted by the Administrator by regulation, which are affected by the revocation or suspension; or
  - (2) Place all of such chemicals under seal as described in section 304(f) of the Act ([21 U.S.C. 824(f)](/usc/21/824.md?p=f)).

# §1309.44. Suspension of registration pending final order.

- (a) The Administrator may suspend any registration simultaneously with or at any time subsequent to the service upon the registrant of an order to show cause why such registration should not be revoked or suspended, in any case where he finds that there is an imminent danger to the public health or safety. If the Administrator so suspends, he shall serve with the order to show cause pursuant to [§ 1309.46](/cfr/21/1309.46.md) an order of immediate suspension that shall contain a statement of his findings regarding the danger to public health or safety.
- (b) Upon service of the order of immediate suspension, the registrant shall promptly return his Certificate of Registration to the nearest office of the Administration. Also, upon service of the order of immediate suspension, the registrant shall, as instructed by the Administrator:
  - (1) Deliver to the nearest office of the Administration or to authorized agents of the Administration all of the particular chemical or chemicals in his or her possession that were obtained under the authority of a registration or an exemption from registration granted by the Administrator by regulation, which are affected by the revocation or suspension; or
  - (2) Place all of such chemicals under seal as described in section 304(f) of the Act ([21 U.S.C. 824(f)](/usc/21/824.md?p=f)).
- (c) Any suspension shall continue in effect until the conclusion of all proceedings upon the revocation or suspension, including any judicial review thereof, unless sooner withdrawn by the Administrator or dissolved by a court of competent jurisdiction. Any registrant whose registration is suspended under this section may request a hearing on the revocation or suspension of his registration at a time earlier than specified in the order to show cause pursuant to [Section 1309.46](/cfr/21/1309.46.md), which request shall be granted by the Administrator, who shall fix a date for such hearing as early as reasonably possible.

# §1309.45. Extension of registration pending final order.


In the event that an applicant for reregistration (who is doing business under a registration previously granted and not revoked or suspended) has applied for reregistration at least 45 days before the date on which the existing registration is due to expire, and the Administrator has issued no order on the application on the date on which the existing registration is due to expire, the existing registration of the applicant shall automatically be extended and continue in effect until the date on which the Administrator so issues his order. The Administrator may extend any other existing registration under the circumstances contemplated in this section even though the registrant failed to apply for reregistration at least 45 days before expiration of the existing registration, with or without request by the registrant, if the Administrator finds that such extension is not inconsistent with the public health and safety.


# §1309.46. Order to show cause.

- (a) If, upon examination of the application for registration from any applicant and other information gathered by the Administration regarding the applicant, the Administrator is unable to make the determinations required by the applicable provisions of section 303 of the Act ([21 U.S.C. 823](/usc/21/823.md)) to register the applicant, the Administrator shall serve upon the applicant an order to show cause why the application for registration should not be denied.
- (b) If, upon information gathered by the Administration regarding any registrant, the Administrator determines that the registration of such registrant is subject to suspension or revocation pursuant to section 304 of the Act ([21 U.S.C. 824](/usc/21/824.md)), the Administrator shall serve upon the registrant an order to show cause why the registration should not be revoked or suspended.
- (c) The order to show cause shall call upon the applicant or registrant to appear before the Administrator at a time and place stated in the order, which shall not be less than 30 days after the date of receipt of the order. The order to show cause shall also contain a statement of the legal basis for such hearing and for the denial, revocation, or suspension of registration and a summary of the matters of fact and law asserted.
- (d)
  - (1) **When to File: Hearing Request.** A party that wishes to request a hearing in response to an order to show cause must file with the Office of the Administrative Law Judges and serve on DEA such request no later than 30 days following the date of receipt of the order to show cause. Service of the request on DEA shall be accomplished by sending it to the address, or email address, provided in the order to show cause.
  - (2) **When to File: Answer.** A party requesting a hearing shall also file with the Office of the Administrative Law Judges and serve on DEA an answer to the order to show cause no later than 30 days following the date of receipt of the order to show cause. A party shall also serve its answer on DEA at the address, or email address, provided in the order to show cause. The presiding officer may, upon a showing of good cause by the party, consider an answer that has been filed out of time.
  - (3) **Contents of Answer; Effect of Failure to Deny.** For each factual allegation in the order to show cause, the answer shall specifically admit, deny, or state that the party does not have, and is unable to obtain, sufficient information to admit or deny the allegation. When a party intends in good faith to deny only a part of an allegation, the party shall specify so much of it as is true and shall deny only the remainder. A statement of a lack of information shall have the effect of a denial. Any factual allegation not denied shall be deemed admitted.
  - (4) **Amendments.** Prior to the issuance of the prehearing ruling, a party may as a matter of right amend its answer one time. Subsequent to the issuance of the prehearing ruling, a party may amend its answer only with leave of the presiding officer. Leave shall be freely granted when justice so requires.
- (e) When authorized by the Administrator, any agent of the Administration may serve the order to show cause.