drug labels must be in English and be understandable. All drugs and drug
products labeling must comply with the labeling requirements under FFDCA
Section 502 and 21 CFR 201.
and Drug Listing: Foreign manufacturers whose drugs are
imported or offered for import into the U.S. are required to register and list every
drug in commercial distribution in the U.S. as required by Section 510 of the
Act and 21 CFR 207. These requirements apply to all manufacturers,
repackers, relabelers, and control laboratories involved in the manufacture,
preparation, propagation, compounding, processing or testing of human or
veterinary drugs and human biological products, including the manufacturer of APIs.
cGMPs: APIs are subject to the adulteration
provisions of Section 501(a)(2)(B) of the FD&C Act, which require all drugs
(APIs and finished pharmaceuticals) to be manufactured in conformance with
CGMP. FDA inspects manufacturing facilities for compliance with cGMP requirements. As discussed in the Q7A Guidance for
firms should establish appropriate controls at all stages of manufacturing to
ensure intermediate and/or API quality.
An API is any substance or mixture of substances intended
to be used in the manufacture of a drug (medicinal) product and that, when used
in the production of a drug, becomes an active ingredient of the drug product.
Such substances are intended to furnish pharmacological activity or other
direct effect in the diagnosis, cure, mitigation, treatment, or prevention of
disease or to affect the structure and function of the body. In general, APIs must
comply with all the applicable requirements discussed above. An API is
inherently misbranded under section 502(f)(1) of the Act [21 U.S.C.
352(f)(1)] because its labeling will not bear adequate directions for its use.
However, an API can only be imported under an exemption to 502(f)(1) of the
FDCA. Section 502(f)(1) provides that an API or bulk chemical that can be used
as an API must have labeling that lists adequate directions for its use, unless
the API is subject to exemptions from labeling such as those found in 21 CFR parts
Please refer to 21
CFR 201.128 - Meaning of "intended uses".
new drugs: Any
investigational drug imported for use in clinical studies must be covered by an
investigational new drug application (IIND), unless exempt per 21
CFR 312.2. The firm should submit the IND before importing the drug product.
It must comply with 21
CFR 312.110(a), including that it is subject to an IND under 21
CFR 312.40. In addition, the labeling must comply with 21
Finished drug products for laboratory/animal use: Persons interested in
importing investigational finished drug products for non-clinical use (such as
in laboratory animals and/or in-vitro tests) must meet the requirement of 21
CFR 312.160. Among other requirements, the drug should be labeled
"CAUTION: Contains a new drug for investigational use only in laboratory
research animals, or for tests in vitro. Not for use in humans." Any
product shipped under 21 CFR 312.160 cannot be diverted to human use.
Finished drug products for educational purposes: Persons interested in importing
drug products for the use in teaching, law enforcement, research, and analysis
must meet the requirement of 21 CFR 201.125. This applies only
to drugs subject to 21 CFR 201.100 (prescription drugs
for human use) or 21
CFR 201.105 (veterinary drugs). This
does not apply to OTC drugs. This
regulation applies to the shipment of Rx drugs (finished dosage form drug products
only) to persons regularly and lawfully engaged in instruction in pharmacy,
chemistry, medicine not involving clinical use, chemical analysis, or physical
In order to import, you will also likely need
to build your own product codes (different from the DRLS National Drug Code
(NDC) numbers) via the Product Code
In order to legally export drugs, products
must meet the following criteria, in accordance with-
the specifications of the foreign purchaser
be in conflict with the laws of the country to which they are intended for
labeled on the outside of the shipping package that they are intended for
be sold or offered for sale in U.S. domestic commerce, and
articles of drug in the U.S. have no exportation restrictions
manufactured specifically for export only may be exported & cannot be marketed in the U.S. [801(e)(1)(D)]
manufactured specifically for U.S. found to be adulterated, misbranded, or
unapproved cannot be exported
keep records (21
CDER issues drug export
certificates per FDCA 801(e)(4).
For information on export certificates,
please contact firstname.lastname@example.org
Additional information on imports and exports is located on the
You may also contact our Import-Export Office
at email@example.com for further
Renu Lal, Pharm.D.
CDER Small Business and Industry Assistance
Issues of this newsletter are archived at http://www.fda.gov/cdersmallbusinesschronicles
This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.