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e-CFR data is current as of September 24, 2020

Title 21Chapter IIPart 1317 → Subpart C


Title 21: Food and Drugs
PART 1317—DISPOSAL


Subpart C—Destruction of Controlled Substances


Contents
§1317.90   Methods of destruction.
§1317.95   Destruction procedures.

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§1317.90   Methods of destruction.

(a) All controlled substances to be destroyed by a registrant, or caused to be destroyed by a registrant pursuant to §1317.95(c), shall be destroyed in compliance with applicable Federal, State, tribal, and local laws and regulations and shall be rendered non-retrievable.

(b) Where multiple controlled substances are comingled, the method of destruction shall be sufficient to render all such controlled substances non-retrievable. When the actual substances collected for destruction are unknown but may reasonably include controlled substances, the method of destruction shall be sufficient to render non-retrievable any controlled substance likely to be present.

(c) The method of destruction shall be consistent with the purpose of rendering all controlled substances to a non-retrievable state in order to prevent diversion of any such substance to illicit purposes and to protect the public health and safety.

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§1317.95   Destruction procedures.

The destruction of any controlled substance shall be in accordance with the following requirements:

(a) Transfer to a person registered or authorized to accept controlled substances for the purpose of destruction. If the controlled substances are transferred to a person registered or authorized to accept the controlled substances for the purpose of destruction, two employees of the transferring registrant shall load and unload or observe the loading and unloading of any controlled substances until transfer is complete.

(b) Transport to a registered location. If the controlled substances are transported by a registrant to a registered location for subsequent destruction, the following procedures shall be followed:

(1) Transportation shall be directly to the registered location (the substances shall be constantly moving towards their final location and unnecessary or unrelated stops and stops of an extended duration shall not occur);

(2) Two employees of the transporting registrant shall accompany the controlled substances to the registered location;

(3) Two employees of the transporting registrant shall load and unload or observe the loading and unloading of the controlled substances until transfer is complete;

(c) Transport to a non-registered location. If the controlled substances are transported by a registrant to a destruction location that is not a registered location, the following procedures shall be followed:

(1) Transportation shall be directly to the destruction location (the substances shall be constantly moving towards their final destruction location and unnecessary or unrelated stops and stops of an extended duration shall not occur);

(2) Two employees of the transporting registrant shall accompany the controlled substances to the destruction location;

(3) Two employees of the transporting registrant shall load and unload or observe the loading and unloading of the controlled substances;

(4) Two employees of the transporting registrant shall handle or observe the handling of any controlled substance until the substance is rendered non-retrievable; and

(5) Two employees of the transporting registrant shall personally witness the destruction of the controlled substance until it is rendered non-retrievable.

(d) On-site destruction. If the controlled substances are destroyed at a registrant's registered location utilizing an on-site method of destruction, the following procedures shall be followed:

(1) Two employees of the registrant shall handle or observe the handling of any controlled substance until the substance is rendered non-retrievable; and

(2) Two employees of the registrant shall personally witness the destruction of the controlled substance until it is rendered non-retrievable.

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