Section 536.515 - Transactions related to the provision of agricultural commodities, medicine, medical devices, replacement parts and components, or software updates for personal, non-commercial use(a) All transactions prohibited by this part that are related to the provision, directly or indirectly, of agricultural commodities, medicine, medical devices, replacement parts and components for medical devices, or software updates for medical devices to an individual who is a specially designated narcotics trafficker are authorized, provided the items are in quantities consistent with personal, non-commercial use.(b) For the purposes of this section, agricultural commodities, medicine, and medical devices are defined as follows:(1)Agricultural commodities. For the purposes of this section, agricultural commodities are:(i) Products that fall within the term "agricultural commodity" as defined in section 102 of the Agricultural Trade Act of 1978 (7 U.S.C. 5602 ); and(ii) That are intended for ultimate use as: (A) Food for humans (including raw, processed, and packaged foods; live animals; vitamins and minerals; food additives or supplements; and bottled drinking water) or animals (including animal feeds);(B) Seeds for food crops;(C) Fertilizers or organic fertilizers; or(D) Reproductive materials (such as live animals, fertilized eggs, embryos, and semen) for the production of food animals.(2)Medicine. For the purposes of this section, medicine is an item that falls within the definition of the term "drug" in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 ).(3)Medical devices. For the purposes of this section, a medical device is an item that falls within the definition of "device" in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 ). Note 1 to § 536.515 . This section does not relieve any person authorized thereunder from complying with any other applicable laws or regulations.
87 FR 78485 , Dec. 21, 2022