FACTORY INSPECTION

SEC. 704. (a)(1) For purposes of enforcement of this Act, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle, being used to transport or hold such food, drugs, devices, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any factory, warehouse, establishment, or consulting laboratory in which [Struck out->][ prescription drugs ][<-Struck out] prescription drugs, nonprescription drugs intended for human use, or restricted devices are manufactured, processed, packed, or held, inspection shall extend to all things therein (including records, files, papers, processes, controls, and facilities) bearing on whether [Struck out->][ prescription drugs ][<-Struck out] prescription drugs, nonprescription drugs intended for human use, or restricted devices which are adulterated or misbranded within the meaning of this Act, or which may not be manufactured, introduced into interstate commerce, or sold, or offered for sale by reason of any provision of this Act, have been or are being manufactured, processed, packed, transported, or held in any such place, or otherwise bearing on violation of this Act. No inspection authorized by the preceding sentence or by paragraph (3) shall extend to financial data, sales data other than shipment data, pricing data, personnel data (other than data as to qualifications of technical and professional personnel performing functions subject to this Act), and research data (other than data relating to new drugs, antibiotic drugs, and devices and subject to reporting and inspection under regulations lawfully issued pursuant to section 505 (i) or (k) [Struck out->][ , section 507 (d) or (g) ][<-Struck out] , section 519, or 520(g), and data relating to other drugs or devices which in the case of a new drug would be subject to reporting or inspection under lawful regulations issued pursuant to section 505(j)). A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be commenced and completed with reasonable promptness.

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SUBCHAPTER C--FEES

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PART 2--FEES RELATING TO DRUGS

SEC. 735. DEFINITIONS.

For purposes of this subchapter:

(1) The term `human drug application' means an application for--

(A) approval of a new drug submitted under section 505(b)(1),

(B) approval of a new drug submitted under section 505(b)(2) 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), or

[Struck out->][ (C) initial certification or initial approval of an antibiotic drug under section 507, or ][<-Struck out]

[Struck out->][ (D) ][<-Struck out] (C) 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 [Struck out->][ Service Act, and ][<-Struck out] Service Act, does not include an application with respect to a large volume parenteral drug product approved before [Struck out->][ September 1, 1992. ][<-Struck out] September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. Such term does include an application for licensure, as described in subparagraph (D), of a large volume biological product intended for single dose injection for intravenous use or infusion.

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(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 allergenic extract product, or an in vitro diagnostic biologic product licensed under section 351 of the Public Health [Struck out->][ Service Act, and ][<-Struck out] Service Act, does not include a large volume parenteral drug product approved before [Struck out->][ September 1, 1992. ][<-Struck out] September 1, 1992, does not include a biological product that is licensed for further manufacturing use only, and does not include a drug that is not distributed commercially and is the subject of an application or supplement submitted by a State or Federal Government entity. Such term does include a large volume biological product intended for single dose injection for intravenous use or infusion.

(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 [Struck out->][ without ][<-Struck out] without substantial further manufacturing.

[Struck out->][ (5) The term `prescription drug establishment' means a foreign or domestic place of business which is-- ][<-Struck out]

[Struck out->][ (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 ][<-Struck out]

[Struck out->][ (B) under the management of a person that is listed as the applicant in a human drug application for a prescription drug product with respect to at least one such product. ][<-Struck out]

For purposes of this paragraph, the term `manufactured' does not include packaging.

(5) The term `prescription drug establishment' means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within 5 miles of each other and at which one or more prescription drug products are manufactured in final dosage form.

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(7) The term `costs of resources allocated for the process for the review of human drug applications' means the expenses incurred in connection with the process for the review of human drug applications for--

(A) officers and employees of the Food and Drug Administration, [Struck out->][ employees under contract with the Food and Drug Administration who work in facilities owned or leased for the Food and Drug Administration, ][<-Struck out] contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, [Struck out->][ and committees, ][<-Struck out] and committees and to contracts with such contractors,

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(8) The term `adjustment factor' applicable to a fiscal year is the lower of--

(A) the Consumer Price Index for all urban consumers (all items; United States city average) for [Struck out->][ August of ][<-Struck out] April of the preceding fiscal year divided by such Index for [Struck out->][ August 1992 ][<-Struck out] April 1997, or

(B) the total of discretionary budget authority provided for programs in the domestic category for the immediately preceding fiscal year (as reported in the Office of Management and Budget sequestration preview report, if available, required under section 254(d) of the Balanced Budget and Emergency Deficit Control Act of 1985) divided by such budget authority for fiscal year [Struck out->][ 1992 ][<-Struck out] 1997 (as reported in the Office of Management and Budget final sequestration report submitted after the end of the 102d Congress, 2d Session).

[Struck out->][ The terms `budget authority' and `category' in subparagraph (B) are as defined in the Balanced Budget and Emergency Deficit Control Act of 1985, as in effect as of September 1, 1992. ][<-Struck out]

(9) The term `affiliate' means a business entity that has a relationship with a second business entity if, directly or indirectly--

(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has power to control, both of the business entities.