106 STAT. 4492 PUBLIC LAW 102-571—OCT. 29,1992

"(A) approval of a new drug submitted under section
505(bXD,

"(B) approval of a new drug submitted under section
505(bX2) after September 30, 1992, which requests
approval of—

"(i) a molecular entity which is an active ingredient
(including any salt or ester of an active ingredient),
or

"(ii) an indication for a use,

that had not been approved under an application submitted
under section 505(b),

"(C) initial certification or initial approval of an anti-
biotic drug under section 507, or

"(D) licensure of a biological product under section
351 of the Public Health Service Act.

Such term does not include a supplement to such an application,
does not include an application with respect to whole blood
or a blood component for transfusion, does not include an
application with respect to a bovine blood product for topical
application licensed before September 1, 1992, an allergenic
extract product, or an in vitro diagnostic biologic product
licensed under section 351 of the Public Health Service Act,
and does not include an application with respect to a large
volume parenteral drug product approved before September
1,1992.

"(2) The term 'supplement' means a request to the Secretary
to approve a change in a human drug application which has
been approved.

"(3) The term 'prescription drug product' means a specific
strength or potency of a drug in final dosage form—

"(A) for which a human drug application has been
approved, and

"(B) which may be dispensed only under prescription
pursuant to section 503(b).

Such term does not include whole blood or a blood component
for transfusion, does not include a bovine blood product for
topical application licensed before September 1, 1992, an aller-
genic extract product, or an in vitro diagnostic biologic product
licensed under section 351 of the Public Health Service Act,
and does not include a large volume parenteral drug product
approved before September 1,1992.

"(4) The term 'final dosage form* means, with respect to
a prescription drug product, a finished dosage form which is
approved for administration to a patient without further manu-
facturing.

"(5) The term 'prescription drug establishment' means a
foreign or domestic place of business which is—

"(A) at one general physical location consisting of one
or more buildings all of which are within 5 miles of each
other, at which one or more prescription drug products
are manufactured in final dosage form, and

"(B) under the management of a person that is listed
as the applicant in a human drug application for a prescrip-
tion drug product with respect to at least one such product.
For purposes of this paragraph, the term 'manufactured* does
not include packaging.