"Reimportation of All Prescription Drugs for Human Use"

Section 3 of the Prescription Drug Marketing Act of 1987 amends Section 801 of the Federal Food, Drug, and Cosmetic Act by creating new subsections 801(d)(1) and (2). New subsection 801(d)(1) prohibits the reimportation of human prescription drugs manufactured in a State (including the District of Columbia and Puerto Rico) except when the product is returned to the person who manufactured it. New Subsection 801(d)(2) provides an exception for the reimportation of prescription drugs when authorized by the Secretary in the case of a medical emergency.

Districts may detain without physical examination all human prescription drugs with the United States as the country of origin (American Goods Returned) except when:

801(d)(1): the drug products are returned to the person who manufactured them (the manufacturer).

or

801(d)(2): the reimportation is authorized by the Secretary (or a delegated authority) in the case of a medical emergency.

Guidance: (a) Subsections 801(d)(1) and (2) should be applied to finished human prescription drugs and to bulk active ingredients as well. Therefore, active ingredients manufactured in the U.S. and offered for reimportation are covered by these provisions. If, however, a U.S. manufactured active ingredient is used to make a finished product in another country, that finished product is a different drug from that which was exported and it would not be subject to the provisions of subsection 801(d)(1).

(b) Under the provisions of subsection 801(d)(1), no one except "the person who manufactured the drug" may reimport an American made prescription human drug. In determining an importer's status as a "manufacturer," bear in mind that manufacturing can include various activities, such as: mixing, labeling, and packaging, or other steps involved in a drug's preparation, depending on the nature of the product and its formulation. Refer any questions regarding whether an importer is the "person who manufactured the drug" (for example, if a repacker or relabeler claims to be the manufacturer) to the appropriate Center Office of Compliance:

Drugs - Center for Drug Evaluation and Research, HFD-300
Biologics - Center for Biologics Evaluation and Research, HFB-100

(c) If there is reason to believe that the importer is not the manufacturer, districts may request additional documentation or perform follow up investigations to confirm the facts.

(d) When and if the district concludes that the drug is being returned to the manufacturer, the district should also perform its usual review of the entry to determine whether the product appears to be adulterated or misbranded. The new legislation does not exempt the original manufacturer from the provisions of 801(a) to allow the import of products that appear to violate the Act. (As usual, however, FDA could use its discretion in appropriate situations to allow the return of certain violative merchandise, i.e., a recall situation.) When performing the usual import review of reimported human prescription drugs be guided by Import Alert #99-01, "Surveillance of American Goods Returned."

(e) When human prescription drugs are offered for entry for use in a medical emergency, district offices should obtain from the importer such information as: (1) the reason this situation should be considered an emergency, (2) availability, during the relevant treatment period, of the product and of alternative products on the domestic market, (3) data supporting the expected duration of the emergency situation and the number of expected users of the re imported drug, and (4) accountability for product that may not be consumed during the emergency, including a plan for disposition of any remaining product at the end of the emergency situation. The district will forward the information supporting the emergency use claim to the appropriate Office of Compliance:

Drugs - Center for Drug Evaluation and Research, HFD-300
Biologics - Center for Biologics Evaluation and Research, HFB-100

NOTE: Drugs found in personal baggage will be subject to FDA's personal baggage policy as described in Chapter 9 72 of the Regulatory Procedures Manual.

Copies of this Import Alert may be provided to local Customs officials and to import brokers as the district deems appropriate.

All human prescription drugs

"The article is subject to refusal of admission pursuant to Section 801(d)(1) in that it is a prescription drug manufactured in the U.S. offered for import by other than the person who manufactured the drug and reimportation has not been authorized by the Secretary for use in a medical emergency as provided under Section 801(d)(2)."

OASIS Charge Code - AGR RX