§ 102-40.165 How do we handle drugs, biologicals, and reagents other than controlled substances? Cross Reference
Link to an amendment published at 89 FR 67867 , Aug. 22, 2024.
( a ) Drugs, biologicals, and reagents other than controlled substances may be transferred to another Federal agency for official purposes under procedures specified in part 102-36 of this subchapter. For donation of drugs, biologicals, or reagents other than controlled substances, follow the procedures in part 102-37 of this subchapter, and paragraph (c) of this section.
( b ) Drugs, biologicals, and reagents other than controlled substances must be clearly identified when they are unfit for human use. As a general rule, you must destroy drugs, biologicals, and reagents unfit for human use, with destruction performed by an agency employee and witnessed and certified by two additional representatives of your agency. Similarly, destruction of this property held by a SASP or donee must be destroyed by a SASP employee and witnessed by two additional SASP employees. Destruction shall be coordinated with local air and water pollution control authorities, when required. However, you may report such property to GSA for subsequent transfer or donation for the purpose of animal experimental use when the property is unfit due to expired shelf life. The following certification, or an equivalent certification, must be used and retained by the Federal agency or SASP to document the destruction of drugs, biologicals, and reagents: We, the undersigned, have witnessed the destruction of the (drugs, biologicals, and reagents) described in the foregoing certification in the manner of destruction and on the date stated herein: Certification of destruction of: ___ Manner in which destruction was performed Date Witness Date Witness Date
( c ) When donating drugs, biologicals, or reagents other than controlled substances, the SASP shall obtain a certification from the donee indicating that the items donated will be safeguarded, dispensed, and administered under competent supervision and in accordance with Federal, state, and local laws and regulations. Surplus drugs, biologicals, and reagents requested for donation by state agencies will not be transported by the state agency or stored in its warehouse prior to distribution to donees. Arrangements will be made by the state agency for the donee to make direct pickup at the holding agency after approval by GSA and after notification by the holding agency that the property is ready for pickup. Additionally, Transfer Order Surplus Personal Property, SF 123 from a state agency requesting surplus drugs, biologicals, and reagents for donation will not be processed or approved by GSA until it has been determined by the GSA donation representative that the specific donee is legally licensed to administer, dispense, store, or distribute such property. A copy of the donee's license, registration, or other legal authorization to administer, dispense, store, or distribute such property should be attached and made a part of the SF 123. The administration or use of drugs, biologicals, and reagents must be in compliance with the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301, *et seq.*).
( d ) The sale of any unexpired drugs, biologicals, or reagents must be in accordance with rules published by the Food and Drug Administration (FDA). You may sell drugs, biologicals, and reagents other than controlled substances, only to those entities legally qualified to engage in the sale, manufacture or distribution of such items and a certification or evidence of licensing must accompany the bids. An entity is legally qualified when a Federal agency (*e.g.,* the Department of Health and Human Services, the DEA, or the Department of Agriculture) or state agency having legal or regulatory oversight over that commodity has approved the entity to engage in the designated activity. ( 1 ) When selling drugs, biologicals, and reagents other than controlled substances, the following condition of sale (or an equivalent condition of sale) must be used: The bidder shall complete, sign, and return with his/her bid the certification as contained in this invitation. No award will be made or sale consummated until after this agency has determined that the bidder is legally licensed to engage in the manufacture, sale, or distribution of drugs.
( 2 ) The following certification, or an equivalent certification, must be made a part of the invitation for bids (and contract), to be completed and signed by the bidder, and returned with the bid with a copy of his/her license. Failure to sign the certification may result in the bid being rejected as nonresponsive.
The undersigned bidder certifies that he/she is legally licensed to engage in the manufacture, sale, or distribution of drugs, and proof of his/her license to deal in such materials is furnished with this bid. This certification is made in accordance with and subject to the penalties of Title 18, Section 1001, United States Code, Crime and Criminal procedures. Name of bidder (print or type) Signature of bidder Address of bidder (print or type) City, State, Zip code