Code of Federal Regulations Title 21. Food and Drugs § 21.1314.115 Distributions not subject to reporting requirements

(1) Distributions of sample packages when those packages contain not more than two solid dosage units or the equivalent of two dosage units in liquid form, not to exceed 10 milliliters of liquid per package, and not more than one package is distributed to an individual or residential address in any 30–day period.

(2) Distributions by retail distributors that may not include face-to-face transactions to the extent that such distributions are consistent with the activities authorized for a retail distributor as specified in the definition of retail distributor in § 1300.02 of this chapter, except that this paragraph (a)(2) does not apply to sales of scheduled listed chemical products at retail.

(3) Distributions to a resident of a long term care facility or distributions to a long term care facility for dispensing to or for use by a resident of that facility.

(4) Distributions in accordance with a valid prescription.