IA#66-14 --- 07/18/88
Effective Date: July 22, 1988
Type of Alert: Automatic detention
Product: All human prescription drugs
Country: United States
Reference: IA#99-01, Surveillance of American Goods Returned
Charge:
"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)."
Reason for Alert:
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.
Instructions:
Automatically detain 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.
FOI: No purging required.
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