117 STAT. 2250
PUBLIC LAW 108–173—DEC. 8, 2003 except under circumstances and settings where an individual currently receives a drug or biological in the individual’s home or other non-physician office setting as the Secretary may provide. The contractor shall not deliver drugs and biologicals to a selecting physician except upon receipt of a prescription for such drugs and biologicals, and such necessary data as may be required by the Secretary to carry out this section. This section does not— ‘‘(i) require a physician to submit a prescription for each individual treatment; or ‘‘(ii) change a physician’s flexibility in terms of writing a prescription for drugs or biologicals for a single treatment or a course of treatment. ‘‘(5) PERMITTING ACCESS TO DRUGS AND BIOLOGICALS.—The Secretary shall establish rules under this section under which drugs and biologicals which are acquired through a contractor under this section may be used to resupply inventories of such drugs and biologicals which are administered consistent with safe drug practices and with adequate safeguards against fraud and abuse. The previous sentence shall apply if the physicians can demonstrate to the Secretary all of the following: ‘‘(A) The drugs or biologicals are required immediately. ‘‘(B) The physician could not have reasonably anticipated the immediate requirement for the drugs or biologicals. ‘‘(C) The contractor could not deliver to the physician the drugs or biologicals in a timely manner. ‘‘(D) The drugs or biologicals were administered in an emergency situation. ‘‘(6) CONSTRUCTION.—Nothing in this section shall be construed as waiving applicable State requirements relating to licensing of pharmacies. ‘‘(c) BIDDING PROCESS.— ‘‘(1) IN GENERAL.—In awarding a contract for a category of drugs and biologicals in an area under the program, the Secretary shall consider with respect to each entity seeking to be awarded a contract the bid price and the other factors referred to in subsection (b)(3). ‘‘(2) BID DEFINED.—In this section, the term ‘bid’ means an offer to furnish a competitively biddable drug or biological for a particular price and time period. ‘‘(3) BIDDING ON A NATIONAL OR REGIONAL BASIS.—Nothing in this section shall be construed as precluding a bidder from bidding for contracts in all areas of the United States or as requiring a bidder to submit a bid for all areas of the United States. ‘‘(4) UNIFORMITY OF BIDS WITHIN AREA.—The amount of the bid submitted under a contract offer for any competitively biddable drug or biological for an area shall be the same for that drug or biological for all portions of that area. ‘‘(5) CONFIDENTIALITY OF BIDS.—The provisions of subparagraph (D) of section 1927(b)(3) shall apply to periods during which a bid is submitted with respect to a competitively biddable drug or biological under this section in the same manner as it applies to information disclosed under such section, except that any reference—
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