		II
		112th CONGRESS
		1st Session
		S. 319
		IN THE SENATE OF THE UNITED STATES

			February 10, 2011
			Ms. Snowe (for herself,
			 Ms. Stabenow, Mr. Vitter, Mr.
			 McCain, Ms. Klobuchar,
			 Mr. Grassley, Mr. Kohl, Ms.
			 Collins, Mr. Brown of Ohio,
			 Mr. Kerry, Mr.
			 Sanders, Mr. Levin,
			 Mrs. Shaheen, Mr. Leahy, Mr. Johnson of
			 South Dakota, Mr. Bingaman,
			 Mrs. McCaskill, Mr. Begich, and Mr. Nelson
			 of Florida) introduced the following bill; which was read twice and
			 referred to the Committee on Health,
			 Education, Labor, and Pensions

		A BILL
		To amend the Federal Food, Drug, and Cosmetic Act with
		  respect to the importation of prescription drugs, and for other
		  purposes.

		1.Short titleThis Act may be cited as the
			 Pharmaceutical Market Access and Drug
			 Safety Act of 2011.
		2.FindingsCongress finds that—
			(1)Americans
			 unjustly pay up to 5 times more to fill their prescriptions than consumers in
			 other countries;
			(2)the United States
			 is the largest market for pharmaceuticals in the world, yet American consumers
			 pay the highest prices for brand pharmaceuticals in the world;
			(3)a prescription
			 drug is neither safe nor effective to an individual who cannot afford
			 it;
			(4)allowing and
			 structuring the importation of prescription drugs to ensure access to safe and
			 affordable drugs approved by the Food and Drug Administration will provide a
			 level of safety to American consumers that they do not currently enjoy;
			(5)Americans spend
			 more than $200,000,000,000 on prescription drugs every year;
			(6)the Congressional
			 Budget Office has found that the cost of prescription drugs are between 35 to
			 55 percent less in other highly-developed countries than in the United States;
			 and
			(7)promoting
			 competitive market pricing would both contribute to health care savings and
			 allow greater access to therapy, improving health and saving lives.
			3.Repeal of
			 certain section regarding importation of prescription drugsChapter VIII of the
			 Federal Food, Drug, and Cosmetic Act
			 (21 U.S.C. 381 et seq.) is amended by striking section 804.
		4.Importation of
			 prescription drugs; waiver of certain import restrictions
			(a)In
			 generalChapter VIII of the Federal Food, Drug, and Cosmetic Act (21
			 U.S.C. 381 et seq.), as amended by section 3, is further amended by inserting
			 after section 803 the following:

					804.Commercial and
				personal importation of prescription drugs
						(a)Importation of
				prescription drugs
							(1)In
				generalIn the case of qualifying drugs imported or offered for
				import into the United States from registered exporters or by registered
				importers—
								(A)the limitation on
				importation that is established in section 801(d)(1) is waived; and
								(B)the standards
				referred to in section 801(a) regarding admission of the drugs are subject to
				subsection (g) of this section (including with respect to qualifying drugs to
				which section 801(d)(1) does not apply).
								(2)ImportersA
				qualifying drug may not be imported under paragraph (1) unless—
								(A)the drug is
				imported by a pharmacy, group of pharmacies, or a wholesaler that is a
				registered importer; or
								(B)the drug is
				imported by an individual for personal use or for the use of a family member of
				the individual (not for resale) from a registered exporter.
								(3)Rule of
				constructionThis section shall apply only with respect to a drug
				that is imported or offered for import into the United States—
								(A)by a registered
				importer; or
								(B)from a registered
				exporter to an individual.
								(4)Definitions
								(A)Registered
				exporter; registered importerFor purposes of this
				section:
									(i)The term
				registered exporter means an exporter for which a registration
				under subsection (b) has been approved and is in effect.
									(ii)The term
				registered importer means a pharmacy, group of pharmacies, or a
				wholesaler for which a registration under subsection (b) has been approved and
				is in effect.
									(iii)The term
				registration condition means a condition that must exist for a
				registration under subsection (b) to be approved.
									(B)Qualifying
				drugFor purposes of this section, the term qualifying
				drug means a drug for which there is a corresponding U.S. label
				drug.
								(C)U.S. label
				drugFor purposes of this section, the term U.S. label
				drug means a prescription drug that—
									(i)with respect to a
				qualifying drug, has the same active ingredient or ingredients, route of
				administration, dosage form, and strength as the qualifying drug;
									(ii)with respect to
				the qualifying drug, is manufactured by or for the person that manufactures the
				qualifying drug;
									(iii)is approved
				under section 505(c); and
									(iv)is not—
										(I)a controlled
				substance, as defined in section 102 of the Controlled Substances Act (21 U.S.C.
				802);
										(II)a biological
				product, as defined in section 351 of the Public
				Health Service Act (42 U.S.C. 262), including—
											(aa)a
				therapeutic DNA plasmid product;
											(bb)a
				therapeutic synthetic peptide product;
											(cc)a
				monoclonal antibody product for in vivo use; and
											(dd)a
				therapeutic recombinant DNA-derived product;
											(III)an infused
				drug, including a peritoneal dialysis solution;
										(IV)an injected
				drug;
										(V)a drug that is
				inhaled during surgery;
										(VI)a drug that is
				the listed drug referred to in 2 or more abbreviated new drug applications
				under which the drug is commercially marketed; or
										(VII)a sterile
				opthlamic drug intended for topical use on or in the eye.
										(D)Other
				definitionsFor purposes of this section:
									(i)(I)The term
				exporter means a person that is in the business of exporting a
				drug to individuals in the United States from Canada or from a permitted
				country designated by the Secretary under subclause (II), or that, pursuant to
				submitting a registration under subsection (b), seeks to be in such
				business.
										(II)The Secretary shall designate a
				permitted country under subparagraph (E) (other than Canada) as a country from
				which an exporter may export a drug to individuals in the United States if the
				Secretary determines that—
											(aa)the country has statutory or
				regulatory standards that are equivalent to the standards in the United States
				and Canada with respect to—
												(AA)the training of pharmacists;
												(BB)the practice of pharmacy; and
												(CC)the protection of the privacy of personal
				medical information; and
												(bb)the importation of drugs to
				individuals in the United States from the country will not adversely affect
				public health.
											(ii)The term
				importer means a pharmacy, a group of pharmacies, or a wholesaler
				that is in the business of importing a drug into the United States or that,
				pursuant to submitting a registration under subsection (b), seeks to be in such
				business.
									(iii)The term
				pharmacist means a person licensed by a State to practice
				pharmacy, including the dispensing and selling of prescription drugs.
									(iv)The term
				pharmacy means a person that—
										(I)is licensed by a
				State to engage in the business of selling prescription drugs at retail;
				and
										(II)employs 1 or
				more pharmacists.
										(v)The term
				prescription drug means a drug that is described in section
				503(b)(1).
									(vi)The term
				wholesaler—
										(I)means a person
				licensed as a wholesaler or distributor of prescription drugs in the United
				States under section 503(e)(2)(A); and
										(II)does not include
				a person authorized to import drugs under section 801(d)(1).
										(E)Permitted
				countryThe term permitted country means—
									(i)Australia;
									(ii)Canada;
									(iii)a member
				country of the European Union, but does not include a member country with
				respect to which—
										(I)the country’s
				Annex to the Treaty of Accession to the European Union 2003 includes a
				transitional measure for the regulation of human pharmaceutical products that
				has not expired; or
										(II)the Secretary
				determines that the requirements described in subclauses (I) and (II) of clause
				(vii) will not be met by the date on which such transitional measure for the
				regulation of human pharmaceutical products expires;
										(iv)Japan;
									(v)New
				Zealand;
									(vi)Switzerland;
				and
									(vii)a country in
				which the Secretary determines the following requirements are met:
										(I)The country has
				statutory or regulatory requirements—
											(aa)that require the
				review of drugs for safety and effectiveness by an entity of the government of
				the country;
											(bb)that authorize
				the approval of only those drugs that have been determined to be safe and
				effective by experts employed by or acting on behalf of such entity and
				qualified by scientific training and experience to evaluate the safety and
				effectiveness of drugs on the basis of adequate and well-controlled
				investigations, including clinical investigations, conducted by experts
				qualified by scientific training and experience to evaluate the safety and
				effectiveness of drugs;
											(cc)that require the
				methods used in, and the facilities and controls used for the manufacture,
				processing, and packing of drugs in the country to be adequate to preserve
				their identity, quality, purity, and strength;
											(dd)for the
				reporting of adverse reactions to drugs and procedures to withdraw approval and
				remove drugs found not to be safe or effective; and
											(ee)that require the
				labeling and promotion of drugs to be in accordance with the approval of the
				drug.
											(II)The valid
				marketing authorization system in the country is equivalent to the systems in
				the countries described in clauses (i) through (vi).
										(III)The importation
				of drugs to the United States from the country will not adversely affect public
				health.
										(b)Registration of
				importers and exporters
							(1)Registration of
				importers and exportersA registration condition is that the
				importer or exporter involved (referred to in this subsection as a
				registrant) submits to the Secretary a registration containing
				the following:
								(A)(i)In the case of an
				exporter, the name of the exporter and an identification of all places of
				business of the exporter that relate to qualifying drugs, including each
				warehouse or other facility owned or controlled by, or operated for, the
				exporter.
									(ii)In the case of an importer, the
				name of the importer and an identification of the places of business of the
				importer at which the importer initially receives a qualifying drug after
				importation (which shall not exceed 3 places of business except by permission
				of the Secretary).
									(B)Such information
				as the Secretary determines to be necessary to demonstrate that the registrant
				is in compliance with registration conditions under—
									(i)in the case of an
				importer, subsections (c), (d), (e), (g), and (j) (relating to the sources of
				imported qualifying drugs; the inspection of facilities of the importer; the
				payment of fees; compliance with the standards referred to in section 801(a);
				and maintenance of records and samples); or
									(ii)in the case of
				an exporter, subsections (c), (d), (f), (g), (h), (i), and (j) (relating to the
				sources of exported qualifying drugs; the inspection of facilities of the
				exporter and the marking of compliant shipments; the payment of fees; and
				compliance with the standards referred to in section 801(a); being licensed as
				a pharmacist; conditions for individual importation; and maintenance of records
				and samples).
									(C)An agreement by
				the registrant that the registrant will not under subsection (a) import or
				export any drug that is not a qualifying drug.
								(D)An agreement by
				the registrant to—
									(i)notify the
				Secretary of a recall or withdrawal of a qualifying drug distributed in a
				permitted country that the registrant has exported or imported, or intends to
				export or import, to the United States under subsection (a);
									(ii)provide for the
				return to the registrant of such drug; and
									(iii)cease, or not
				begin, the exportation or importation of such drug unless the Secretary has
				notified the registrant that exportation or importation of such drug may
				proceed.
									(E)An agreement by
				the registrant to ensure and monitor compliance with each registration
				condition, to promptly correct any noncompliance with such a condition, and to
				promptly report to the Secretary any such noncompliance.
								(F)A plan describing
				the manner in which the registrant will comply with the agreement under
				subparagraph (E).
								(G)An agreement by
				the registrant to enforce a contract under subsection (c)(3)(B) against a party
				in the chain of custody of a qualifying drug with respect to the authority of
				the Secretary under clauses (ii) and (iii) of that subsection.
								(H)An agreement by
				the registrant to notify the Secretary not more than 30 days before the
				registrant intends to make the change, of—
									(i)any change that
				the registrant intends to make regarding information provided under
				subparagraph (A) or (B); and
									(ii)any change that
				the registrant intends to make in the compliance plan under subparagraph
				(F).
									(I)In the case of an
				exporter:
									(i)An agreement by
				the exporter that a qualifying drug will not under subsection (a) be exported
				to any individual not authorized pursuant to subsection (a)(2)(B) to be an
				importer of such drug.
									(ii)An agreement to
				post a bond, payable to the Treasury of the United States that is equal in
				value to the lesser of—
										(I)the value of
				drugs exported by the exporter to the United States in a typical 4-week period
				over the course of a year under this section; or
										(II)$1,000,000.
										(iii)An agreement by
				the exporter to comply with applicable provisions of Canadian law, or the law
				of the permitted country designated under subsection (a)(4)(D)(i)(II) in which
				the exporter is located, that protect the privacy of personal information with
				respect to each individual importing a prescription drug from the exporter
				under subsection (a)(2)(B).
									(iv)An agreement by
				the exporter to report to the Secretary—
										(I)not later than
				August 1 of each fiscal year, the total price and the total volume of drugs
				exported to the United States by the exporter during the 6-month period from
				January 1 through June 30 of that year; and
										(II)not later than
				January 1 of each fiscal year, the total price and the total volume of drugs
				exported to the United States by the exporter during the previous fiscal
				year.
										(J)In the case of an
				importer, an agreement by the importer to report to the Secretary—
									(i)not later than
				August 1 of each fiscal year, the total price and the total volume of drugs
				imported to the United States by the importer during the 6-month period from
				January 1 through June 30 of that fiscal year; and
									(ii)not later than
				January 1 of each fiscal year, the total price and the total volume of drugs
				imported to the United States by the importer during the previous fiscal
				year.
									(K)Such other
				provisions as the Secretary may require by regulation to protect the public
				health while permitting—
									(i)the importation
				by pharmacies, groups of pharmacies, and wholesalers as registered importers of
				qualifying drugs under subsection (a); and
									(ii)importation by
				individuals of qualifying drugs under subsection (a).
									(2)Approval or
				disapproval of registration
								(A)In
				generalNot later than 90 days after the date on which a
				registrant submits to the Secretary a registration under paragraph (1), the
				Secretary shall notify the registrant whether the registration is approved or
				is disapproved. The Secretary shall disapprove a registration if there is
				reason to believe that the registrant is not in compliance with one or more
				registration conditions, and shall notify the registrant of such reason. In the
				case of a disapproved registration, the Secretary shall subsequently notify the
				registrant that the registration is approved if the Secretary determines that
				the registrant is in compliance with such conditions.
								(B)Changes in
				registration informationNot later than 30 days after receiving a
				notice under paragraph (1)(H) from a registrant, the Secretary shall determine
				whether the change involved affects the approval of the registration of the
				registrant under paragraph (1), and shall inform the registrant of the
				determination.
								(3)Publication of
				contact information for registered exportersThrough the Internet
				website of the Food and Drug Administration and a toll-free telephone number,
				the Secretary shall make readily available to the public a list of registered
				exporters, including contact information for the exporters. Promptly after the
				approval of a registration submitted under paragraph (1), the Secretary shall
				update the Internet website and the information provided through the toll-free
				telephone number accordingly.
							(4)Suspension and
				termination
								(A)SuspensionWith
				respect to the effectiveness of a registration submitted under paragraph
				(1):
									(i)Subject to clause
				(ii), the Secretary may suspend the registration if the Secretary determines,
				after notice and opportunity for a hearing, that the registrant has failed to
				maintain substantial compliance with a registration condition.
									(ii)If the Secretary
				determines that, under color of the registration, the exporter has exported a
				drug or the importer has imported a drug that is not a qualifying drug, or a
				drug that does not comply with subsection (g)(2)(A) or (g)(4), or has exported
				a qualifying drug to an individual in violation of subsection (i), the
				Secretary shall immediately suspend the registration. A suspension under the
				preceding sentence is not subject to the provision by the Secretary of prior
				notice, and the Secretary shall provide to the registrant an opportunity for a
				hearing not later than 10 days after the date on which the registration is
				suspended.
									(iii)The Secretary
				may reinstate the registration, whether suspended under clause (i) or (ii), if
				the Secretary determines that the registrant has demonstrated that further
				violations of registration conditions will not occur.
									(B)TerminationThe
				Secretary, after notice and opportunity for a hearing, may terminate the
				registration under paragraph (1) of a registrant if the Secretary determines
				that the registrant has engaged in a pattern or practice of violating 1 or more
				registration conditions, or if on 1 or more occasions the Secretary has under
				subparagraph (A)(ii) suspended the registration of the registrant. The
				Secretary may make the termination permanent, or for a fixed period of not less
				than 1 year. During the period in which the registration is terminated, any
				registration submitted under paragraph (1) by the registrant, or a person that
				is a partner in the export or import enterprise, or a principal officer in such
				enterprise, and any registration prepared with the assistance of the registrant
				or such a person, has no legal effect under this section.
								(5)Default of
				bondA bond required to be posted by an exporter under paragraph
				(1)(I)(ii) shall be defaulted and paid to the Treasury of the United States if,
				after opportunity for an informal hearing, the Secretary determines that the
				exporter has—
								(A)exported a drug
				to the United States that is not a qualifying drug or that is not in compliance
				with subsection (g)(2)(A), (g)(4), or (i); or
								(B)failed to permit
				the Secretary to conduct an inspection described under subsection (d).
								(c)Sources of
				qualifying drugsA registration condition is that the exporter or
				importer involved agrees that a qualifying drug will under subsection (a) be
				exported or imported into the United States only if there is compliance with
				the following:
							(1)The drug was
				manufactured in an establishment—
								(A)required to
				register under subsection (h) or (i) of section 510; and
								(B)(i)inspected by the
				Secretary; or
									(ii)for which the Secretary has
				elected to rely on a satisfactory report of a good manufacturing practice
				inspection of the establishment from a permitted country whose regulatory
				system the Secretary recognizes as equivalent under a mutual recognition
				agreement, as provided for under section 510(i)(3), section 803, or part 26 of
				title 21, Code of Federal Regulations (or any corresponding successor rule or
				regulation).
									(2)The establishment
				is located in any country, and the establishment manufactured the drug for
				distribution in the United States or for distribution in 1 or more of the
				permitted countries (without regard to whether in addition the drug is
				manufactured for distribution in a foreign country that is not a permitted
				country).
							(3)The exporter or
				importer obtained the drug—
								(A)directly from the
				establishment; or
								(B)directly from an
				entity that, by contract with the exporter or importer—
									(i)provides to the
				exporter or importer a statement (in such form and containing such information
				as the Secretary may require) that, for the chain of custody from the
				establishment, identifies each prior sale, purchase, or trade of the drug
				(including the date of the transaction and the names and addresses of all
				parties to the transaction);
									(ii)agrees to permit
				the Secretary to inspect such statements and related records to determine their
				accuracy;
									(iii)agrees, with
				respect to the qualifying drugs involved, to permit the Secretary to inspect
				warehouses and other facilities, including records, of the entity for purposes
				of determining whether the facilities are in compliance with any standards
				under this Act that are applicable to facilities of that type in the United
				States; and
									(iv)has ensured,
				through such contractual relationships as may be necessary, that the Secretary
				has the same authority regarding other parties in the chain of custody from the
				establishment that the Secretary has under clauses (ii) and (iii) regarding
				such entity.
									(4)(A)The foreign country
				from which the importer will import the drug is a permitted country; or
								(B)the foreign country from which the
				exporter will export the drug is the permitted country in which the exporter is
				located.
								(5)During any period
				in which the drug was not in the control of the manufacturer of the drug, the
				drug did not enter any country that is not a permitted country.
							(6)The exporter or
				importer retains a sample of each lot of the drug for testing by the
				Secretary.
							(d)Inspection of
				facilities; marking of shipments
							(1)Inspection of
				facilitiesA registration condition is that, for the purpose of
				assisting the Secretary in determining whether the exporter involved is in
				compliance with all other registration conditions—
								(A)the exporter
				agrees to permit the Secretary—
									(i)to conduct onsite
				inspections, including monitoring on a day-to-day basis, of places of business
				of the exporter that relate to qualifying drugs, including each warehouse or
				other facility owned or controlled by, or operated for, the exporter;
									(ii)to have access,
				including on a day-to-day basis, to—
										(I)records of the
				exporter that relate to the export of such drugs, including financial records;
				and
										(II)samples of such
				drugs;
										(iii)to carry out
				the duties described in paragraph (3); and
									(iv)to carry out any
				other functions determined by the Secretary to be necessary regarding the
				compliance of the exporter; and
									(B)the Secretary has
				assigned 1 or more employees of the Secretary to carry out the functions
				described in this subsection for the Secretary randomly, but not less than 12
				times annually, on the premises of places of businesses referred to in
				subparagraph (A)(i), and such an assignment remains in effect on a continuous
				basis.
								(2)Marking of
				compliant shipmentsA registration condition is that the exporter
				involved agrees to affix to each shipping container of qualifying drugs
				exported under subsection (a) such markings as the Secretary determines to be
				necessary to identify the shipment as being in compliance with all registration
				conditions. Markings under the preceding sentence shall—
								(A)be designed to
				prevent affixation of the markings to any shipping container that is not
				authorized to bear the markings; and
								(B)include
				anticounterfeiting or track-and-trace technologies, taking into account the
				economic and technical feasibility of those technologies.
								(3)Certain duties
				relating to exportersDuties of the Secretary with respect to an
				exporter include the following:
								(A)Inspecting,
				randomly, but not less than 12 times annually, the places of business of the
				exporter at which qualifying drugs are stored and from which qualifying drugs
				are shipped.
								(B)During the
				inspections under subparagraph (A), verifying the chain of custody of a
				statistically significant sample of qualifying drugs from the establishment in
				which the drug was manufactured to the exporter, which shall be accomplished or
				supplemented by the use of anticounterfeiting or track-and-trace technologies,
				taking into account the economic and technical feasibility of those
				technologies, except that a drug that lacks such technologies from the point of
				manufacture shall not for that reason be excluded from importation by an
				exporter.
								(C)Randomly
				reviewing records of exports to individuals for the purpose of determining
				whether the drugs are being imported by the individuals in accordance with the
				conditions under subsection (i). Such reviews shall be conducted in a manner
				that will result in a statistically significant determination of compliance
				with all such conditions.
								(D)Monitoring the
				affixing of markings under paragraph (2).
								(E)Inspecting as the
				Secretary determines is necessary the warehouses and other facilities,
				including records, of other parties in the chain of custody of qualifying
				drugs.
								(F)Determining
				whether the exporter is in compliance with all other registration
				conditions.
								(4)Prior notice of
				shipmentsA registration condition is that, not less than 8 hours
				and not more than 5 days in advance of the time of the importation of a
				shipment of qualifying drugs, the importer involved agrees to submit to the
				Secretary a notice with respect to the shipment of drugs to be imported or
				offered for import into the United States under subsection (a). A notice under
				the preceding sentence shall include—
								(A)the name and
				complete contact information of the person submitting the notice;
								(B)the name and
				complete contact information of the importer involved;
								(C)the identity of
				the drug, including the established name of the drug, the quantity of the drug,
				and the lot number assigned by the manufacturer;
								(D)the identity of
				the manufacturer of the drug, including the identity of the establishment at
				which the drug was manufactured;
								(E)the country from
				which the drug is shipped;
								(F)the name and
				complete contact information for the shipper of the drug;
								(G)anticipated
				arrival information, including the port of arrival and crossing location within
				that port, and the date and time;
								(H)a summary of the
				chain of custody of the drug from the establishment in which the drug was
				manufactured to the importer;
								(I)a declaration as
				to whether the Secretary has ordered that importation of the drug from the
				permitted country cease under subsection (g)(2)(C) or (D); and
								(J)such other
				information as the Secretary may require by regulation.
								(5)Marking of
				compliant shipmentsA registration condition is that the importer
				involved agrees, before wholesale distribution (as defined in section 503(e))
				of a qualifying drug that has been imported under subsection (a), to affix to
				each container of such drug such markings or other technology as the Secretary
				determines necessary to identify the shipment as being in compliance with all
				registration conditions, except that the markings or other technology shall not
				be required on a drug that bears comparable, compatible markings or technology
				from the manufacturer of the drug. Markings or other technology under the
				preceding sentence shall—
								(A)be designed to
				prevent affixation of the markings or other technology to any container that is
				not authorized to bear the markings; and
								(B)shall include
				anticounterfeiting or track-and-trace technologies, taking into account the
				economic and technical feasibility of such technologies.
								(6)Certain duties
				relating to importersDuties of the Secretary with respect to an
				importer include the following:
								(A)Inspecting,
				randomly, but not less than 12 times annually, the places of business of the
				importer at which a qualifying drug is initially received after
				importation.
								(B)During the
				inspections under subparagraph (A), verifying the chain of custody of a
				statistically significant sample of qualifying drugs from the establishment in
				which the drug was manufactured to the importer, which shall be accomplished or
				supplemented by the use of anticounterfeiting or track-and-trace technologies,
				taking into account the economic and technical feasibility of those
				technologies, except that a drug that lacks such technologies from the point of
				manufacture shall not for that reason be excluded from importation by an
				importer.
								(C)Reviewing notices
				under paragraph (4).
								(D)Inspecting as the
				Secretary determines is necessary the warehouses and other facilities,
				including records of other parties in the chain of custody of qualifying
				drugs.
								(E)Determining
				whether the importer is in compliance with all other registration
				conditions.
								(e)Importer
				fees
							(1)Registration
				feeA registration condition is that the importer involved pays
				to the Secretary a fee of $10,000 due on the date on which the importer first
				submits the registration to the Secretary under subsection (b).
							(2)Inspection
				feeA registration condition is that the importer involved pays a
				fee to the Secretary in accordance with this subsection. Such fee shall be paid
				not later than October 1 and April 1 of each fiscal year in the amount provided
				for under paragraph (3).
							(3)Amount of
				inspection fee
								(A)Aggregate total
				of feesNot later than 30 days before the start of each fiscal
				year, the Secretary, in consultation with the Secretary of Homeland Security
				and the Secretary of the Treasury, shall establish an aggregate total of fees
				to be collected under paragraph (2) for importers for that fiscal year that is
				sufficient, and not more than necessary, to pay the costs for that fiscal year
				of administering this section with respect to registered importers, including
				the costs associated with—
									(i)inspecting the
				facilities of registered importers, and of other entities in the chain of
				custody of a qualifying drug as necessary, under subsection (d)(6);
									(ii)developing,
				implementing, and operating under such subsection an electronic system for
				submission and review of the notices required under subsection (d)(4) with
				respect to shipments of qualifying drugs under subsection (a) to assess
				compliance with all registration conditions when such shipments are offered for
				import into the United States; and
									(iii)inspecting such
				shipments as necessary, when offered for import into the United States to
				determine if such a shipment should be refused admission under subsection
				(g)(5).
									(B)LimitationSubject
				to subparagraph (C), the aggregate total of fees collected under paragraph (2)
				for a fiscal year shall not exceed 2.5 percent of the total price of qualifying
				drugs imported during that fiscal year into the United States by registered
				importers under subsection (a).
								(C)Total price of
				drugs
									(i)EstimateFor
				the purposes of complying with the limitation described in subparagraph (B)
				when establishing under subparagraph (A) the aggregate total of fees to be
				collected under paragraph (2) for a fiscal year, the Secretary shall estimate
				the total price of qualifying drugs imported into the United States by
				registered importers during that fiscal year by adding the total price of
				qualifying drugs imported by each registered importer during the 6-month period
				from January 1 through June 30 of the previous fiscal year, as reported to the
				Secretary by each registered importer under subsection (b)(1)(J).
									(ii)CalculationNot
				later than March 1 of the fiscal year that follows the fiscal year for which
				the estimate under clause (i) is made, the Secretary shall calculate the total
				price of qualifying drugs imported into the United States by registered
				importers during that fiscal year by adding the total price of qualifying drugs
				imported by each registered importer during that fiscal year, as reported to
				the Secretary by each registered importer under subsection (b)(1)(J).
									(iii)AdjustmentIf
				the total price of qualifying drugs imported into the United States by
				registered importers during a fiscal year as calculated under clause (ii) is
				less than the aggregate total of fees collected under paragraph (2) for that
				fiscal year, the Secretary shall provide for a pro-rata reduction in the fee
				due from each registered importer on April 1 of the subsequent fiscal year so
				that the limitation described in subparagraph (B) is observed.
									(D)Individual
				importer feeSubject to the limitation described in subparagraph
				(B), the fee under paragraph (2) to be paid on October 1 and April 1 by an
				importer shall be an amount that is proportional to a reasonable estimate by
				the Secretary of the semiannual share of the importer of the volume of
				qualifying drugs imported by importers under subsection (a).
								(4)Use of
				fees
								(A)In
				generalFees collected by the Secretary under paragraphs (1) and
				(2) shall be credited to the appropriation account for salaries and expenses of
				the Food and Drug Administration until expended (without fiscal year
				limitation), and the Secretary may, in consultation with the Secretary of
				Homeland Security and the Secretary of the Treasury, transfer some proportion
				of such fees to the appropriation account for salaries and expenses of the
				Bureau of Customs and Border Protection until expended (without fiscal year
				limitation).
								(B)AvailabilityFees
				collected by the Secretary under paragraphs (1) and (2) shall be made available
				to the Food and Drug Administration.
								(C)Sole
				purposeFees collected by the Secretary under paragraphs (1) and
				(2) are only available to the Secretary and, if transferred, to the Secretary
				of Homeland Security, and are for the sole purpose of paying the costs referred
				to in paragraph (3)(A).
								(5)Collection of
				feesIn any case where the Secretary does not receive payment of
				a fee assessed under paragraph (1) or (2) within 30 days after it is due, such
				fee shall be treated as a claim of the United States Government subject to
				subchapter II of chapter 37 of title 31, United States Code.
							(f)Exporter
				fees
							(1)Registration
				feeA registration condition is that the exporter involved pays
				to the Secretary a fee of $10,000 due on the date on which the exporter first
				submits that registration to the Secretary under subsection (b).
							(2)Inspection
				feeA registration condition is that the exporter involved pays a
				fee to the Secretary in accordance with this subsection. Such fee shall be paid
				not later than October 1 and April 1 of each fiscal year in the amount provided
				for under paragraph (3).
							(3)Amount of
				inspection fee
								(A)Aggregate total
				of feesNot later than 30 days before the start of each fiscal
				year, the Secretary, in consultation with the Secretary of Homeland Security
				and the Secretary of the Treasury, shall establish an aggregate total of fees
				to be collected under paragraph (2) for exporters for that fiscal year that is
				sufficient, and not more than necessary, to pay the costs for that fiscal year
				of administering this section with respect to registered exporters, including
				the costs associated with—
									(i)inspecting the
				facilities of registered exporters, and of other entities in the chain of
				custody of a qualifying drug as necessary, under subsection (d)(3);
									(ii)developing,
				implementing, and operating under such subsection a system to screen marks on
				shipments of qualifying drugs under subsection (a) that indicate compliance
				with all registration conditions, when such shipments are offered for import
				into the United States; and
									(iii)screening such
				markings, and inspecting such shipments as necessary, when offered for import
				into the United States to determine if such a shipment should be refused
				admission under subsection (g)(5).
									(B)LimitationSubject
				to subparagraph (C), the aggregate total of fees collected under paragraph (2)
				for a fiscal year shall not exceed 2.5 percent of the total price of qualifying
				drugs imported during that fiscal year into the United States by registered
				exporters under subsection (a).
								(C)Total price of
				drugs
									(i)EstimateFor
				the purposes of complying with the limitation described in subparagraph (B)
				when establishing under subparagraph (A) the aggregate total of fees to be
				collected under paragraph (2) for a fiscal year, the Secretary shall estimate
				the total price of qualifying drugs imported into the United States by
				registered exporters during that fiscal year by adding the total price of
				qualifying drugs exported by each registered exporter during the 6-month period
				from January 1 through June 30 of the previous fiscal year, as reported to the
				Secretary by each registered exporter under subsection (b)(1)(I)(iv).
									(ii)CalculationNot
				later than March 1 of the fiscal year that follows the fiscal year for which
				the estimate under clause (i) is made, the Secretary shall calculate the total
				price of qualifying drugs imported into the United States by registered
				exporters during that fiscal year by adding the total price of qualifying drugs
				exported by each registered exporter during that fiscal year, as reported to
				the Secretary by each registered exporter under subsection
				(b)(1)(I)(iv).
									(iii)AdjustmentIf
				the total price of qualifying drugs imported into the United States by
				registered exporters during a fiscal year as calculated under clause (ii) is
				less than the aggregate total of fees collected under paragraph (2) for that
				fiscal year, the Secretary shall provide for a pro-rata reduction in the fee
				due from each registered exporter on April 1 of the subsequent fiscal year so
				that the limitation described in subparagraph (B) is observed.
									(D)Individual
				exporter feeSubject to the limitation described in subparagraph
				(B), the fee under paragraph (2) to be paid on October 1 and April 1 by an
				exporter shall be an amount that is proportional to a reasonable estimate by
				the Secretary of the semiannual share of the exporter of the volume of
				qualifying drugs exported by exporters under subsection (a).
								(4)Use of
				fees
								(A)In
				generalFees collected by the Secretary under paragraphs (1) and
				(2) shall be credited to the appropriation account for salaries and expenses of
				the Food and Drug Administration until expended (without fiscal year
				limitation), and the Secretary may, in consultation with the Secretary of
				Homeland Security and the Secretary of the Treasury, transfer some proportion
				of such fees to the appropriation account for salaries and expenses of the
				Bureau of Customs and Border Protection until expended (without fiscal year
				limitation).
								(B)AvailabilityFees
				collected by the Secretary under paragraphs (1) and (2) shall be made available
				to the Food and Drug Administration.
								(C)Sole
				purposeFees collected by the Secretary under paragraphs (1) and
				(2) are only available to the Secretary and, if transferred, to the Secretary
				of Homeland Security, and are for the sole purpose of paying the costs referred
				to in paragraph (3)(A).
								(5)Collection of
				feesIn any case where the Secretary does not receive payment of
				a fee assessed under paragraph (1) or (2) within 30 days after it is due, such
				fee shall be treated as a claim of the United States Government subject to
				subchapter II of chapter 37 of title 31, United States Code.
							(g)Compliance with
				Section 801(a)
							(1)In
				generalA registration condition is that each qualifying drug
				exported under subsection (a) by the registered exporter involved or imported
				under subsection (a) by the registered importer involved is in compliance with
				the standards referred to in section 801(a) regarding admission of the drug
				into the United States, subject to paragraphs (2), (3), and (4).
							(2)Section 505;
				approval status
								(A)In
				generalA qualifying drug that is imported or offered for import
				under subsection (a) shall comply with the conditions established in the
				approved application under section 505(b) for the U.S. label drug as described
				under this subsection.
								(B)Notice by
				manufacturer; general provisions
									(i)In
				generalThe person that manufactures a qualifying drug that is,
				or will be, introduced for commercial distribution in a permitted country shall
				in accordance with this paragraph submit to the Secretary a notice that—
										(I)includes each
				difference in the qualifying drug from a condition established in the approved
				application for the U.S. label drug beyond—
											(aa)the variations
				provided for in the application; and
											(bb)any difference
				in labeling (except ingredient labeling); or
											(II)states that
				there is no difference in the qualifying drug from a condition established in
				the approved application for the U.S. label drug beyond—
											(aa)the variations
				provided for in the application; and
											(bb)any difference
				in labeling (except ingredient labeling).
											(ii)Information in
				noticeA notice under clause (i)(I) shall include the information
				that the Secretary may require under section 506A, any additional information
				the Secretary may require (which may include data on bioequivalence if such
				data are not required under section 506A), and, with respect to the permitted
				country that approved the qualifying drug for commercial distribution, or with
				respect to which such approval is sought, include the following:
										(I)The date on which
				the qualifying drug with such difference was, or will be, introduced for
				commercial distribution in the permitted country.
										(II)Information
				demonstrating that the person submitting the notice has also notified the
				government of the permitted country in writing that the person is submitting to
				the Secretary a notice under clause (i)(I), which notice describes the
				difference in the qualifying drug from a condition established in the approved
				application for the U.S. label drug.
										(III)The information
				that the person submitted or will submit to the government of the permitted
				country for purposes of obtaining approval for commercial distribution of the
				drug in the country which, if in a language other than English, shall be
				accompanied by an English translation verified to be complete and accurate,
				with the name, address, and a brief statement of the qualifications of the
				person that made the translation.
										(iii)CertificationsThe
				chief executive officer and the chief medical officer of the manufacturer
				involved shall each certify in the notice under clause (i) that—
										(I)the information
				provided in the notice is complete and true; and
										(II)a copy of the
				notice has been provided to the Federal Trade Commission and to the State
				attorneys general.
										(iv)Fee
										(I)In
				generalIf a notice submitted under clause (i) includes a
				difference that would, under section 506A, require the submission of a
				supplemental application if made as a change to the U.S. label drug, the person
				that submits the notice shall pay to the Secretary a fee in the same amount as
				would apply if the person were paying a fee pursuant to section
				736(a)(1)(A)(ii). Fees collected by the Secretary under the preceding sentence
				are available only to the Secretary and are for the sole purpose of paying the
				costs of reviewing notices submitted under clause (i).
										(II)Fee amount for
				certain yearsIf no fee amount is in effect under section
				736(a)(1)(A)(ii) for a fiscal year, then the amount paid by a person under
				subclause (I) shall—
											(aa)for the first
				fiscal year in which no fee amount under such section in effect, be equal to
				the fee amount under section 736(a)(1)(A)(ii) for the most recent fiscal year
				for which such section was in effect, adjusted in accordance with section
				736(c); and
											(bb)for each
				subsequent fiscal year in which no fee amount under such section is effect, be
				equal to the applicable fee amount for the previous fiscal year, adjusted in
				accordance with section 736(c).
											(v)Timing of
				submission of notices
										(I)Prior approval
				noticesA notice under clause (i) to which subparagraph (C)
				applies shall be submitted to the Secretary not later than 120 days before the
				qualifying drug with the difference is introduced for commercial distribution
				in a permitted country, unless the country requires that distribution of the
				qualifying drug with the difference begin less than 120 days after the country
				requires the difference.
										(II)Other approval
				noticesA notice under clause (i) to which subparagraph (D)
				applies shall be submitted to the Secretary not later than the day on which the
				qualifying drug with the difference is introduced for commercial distribution
				in a permitted country.
										(III)Other
				noticesA notice under clause (i) to which subparagraph (E)
				applies shall be submitted to the Secretary on the date that the qualifying
				drug is first introduced for commercial distribution in a permitted country and
				annually thereafter.
										(vi)Review by
				Secretary
										(I)In
				generalIn this paragraph, the difference in a qualifying drug
				that is submitted in a notice under clause (i) from the U.S. label drug shall
				be treated by the Secretary as if it were a manufacturing change to the U.S.
				label drug under section 506A.
										(II)Standard of
				reviewExcept as provided in subclause (III), the Secretary shall
				review and approve or disapprove the difference in a notice submitted under
				clause (i), if required under section 506A, using the safe and effective
				standard for approving or disapproving a manufacturing change under section
				506A.
										(III)BioequivalenceIf
				the Secretary would approve the difference in a notice submitted under clause
				(i) using the safe and effective standard under section 506A and if the
				Secretary determines that the qualifying drug is not bioequivalent to the U.S.
				label drug, the Secretary shall—
											(aa)include in the
				labeling provided under paragraph (3) a prominent advisory that the qualifying
				drug is safe and effective but is not bioequivalent to the U.S. label drug if
				the Secretary determines that such an advisory is necessary for health care
				practitioners and patients to use the qualifying drug safely and effectively;
				or
											(bb)decline to
				approve the difference if the Secretary determines that the availability of
				both the qualifying drug and the U.S. label drug would pose a threat to the
				public health.
											(IV)Review by the
				SecretaryThe Secretary shall review and approve or disapprove
				the difference in a notice submitted under clause (i), if required under
				section 506A, not later than 120 days after the date on which the notice is
				submitted.
										(V)Establishment
				inspectionIf review of such difference would require an
				inspection of the establishment in which the qualifying drug is
				manufactured—
											(aa)such inspection
				by the Secretary shall be authorized; and
											(bb)the Secretary
				may rely on a satisfactory report of a good manufacturing practice inspection
				of the establishment from a permitted country whose regulatory system the
				Secretary recognizes as equivalent under a mutual recognition agreement, as
				provided under section 510(i)(3), section 803, or part 26 of title 21, Code of
				Federal Regulations (or any corresponding successor rule or regulation).
											(vii)Publication
				of information on notices
										(I)In
				generalThrough the Internet website of the Food and Drug
				Administration and a toll-free telephone number, the Secretary shall readily
				make available to the public a list of notices submitted under clause
				(i).
										(II)ContentsThe
				list under subclause (I) shall include the date on which a notice is submitted
				and whether—
											(aa)a
				notice is under review;
											(bb)the Secretary
				has ordered that importation of the qualifying drug from a permitted country
				cease; or
											(cc)the importation
				of the drug is permitted under subsection (a).
											(III)UpdateThe
				Secretary shall promptly update the Internet website with any changes to the
				list.
										(C)Notice; drug
				difference requiring prior approvalIn the case of a notice under
				subparagraph (B)(i) that includes a difference that would, under subsection (c)
				or (d)(3)(B)(i) of section 506A, require the approval of a supplemental
				application before the difference could be made to the U.S. label drug the
				following shall occur:
									(i)Promptly after
				the notice is submitted, the Secretary shall notify registered exporters,
				registered importers, the Federal Trade Commission, and the State attorneys
				general that the notice has been submitted with respect to the qualifying drug
				involved.
									(ii)If the Secretary
				has not made a determination whether such a supplemental application regarding
				the U.S. label drug would be approved or disapproved by the date on which the
				qualifying drug involved is to be introduced for commercial distribution in a
				permitted country, the Secretary shall—
										(I)order that the
				importation of the qualifying drug involved from the permitted country not
				begin until the Secretary completes review of the notice; and
										(II)promptly notify
				registered exporters, registered importers, the Federal Trade Commission, and
				the State attorneys general of the order.
										(iii)If the
				Secretary determines that such a supplemental application regarding the U.S.
				label drug would not be approved, the Secretary shall—
										(I)order that the
				importation of the qualifying drug involved from the permitted country cease,
				or provide that an order under clause (ii), if any, remains in effect;
										(II)notify the
				permitted country that approved the qualifying drug for commercial distribution
				of the determination; and
										(III)promptly notify
				registered exporters, registered importers, the Federal Trade Commission, and
				the State attorneys general of the determination.
										(iv)If the Secretary
				determines that such a supplemental application regarding the U.S. label drug
				would be approved, the Secretary shall—
										(I)vacate the order
				under clause (ii), if any;
										(II)consider the
				difference to be a variation provided for in the approved application for the
				U.S. label drug;
										(III)permit
				importation of the qualifying drug under subsection (a); and
										(IV)promptly notify
				registered exporters, registered importers, the Federal Trade Commission, and
				the State attorneys general of the determination.
										(D)Notice; drug
				difference not requiring prior approvalIn the case of a notice
				under subparagraph (B)(i) that includes a difference that would, under section
				506A(d)(3)(B)(ii), not require the approval of a supplemental application
				before the difference could be made to the U.S. label drug the following shall
				occur:
									(i)During the period
				in which the notice is being reviewed by the Secretary, the authority under
				this subsection to import the qualifying drug involved continues in
				effect.
									(ii)If the Secretary
				determines that such a supplemental application regarding the U.S. label drug
				would not be approved, the Secretary shall—
										(I)order that the
				importation of the qualifying drug involved from the permitted country
				cease;
										(II)notify the
				permitted country that approved the qualifying drug for commercial distribution
				of the determination; and
										(III)promptly notify
				registered exporters, registered importers, the Federal Trade Commission, and
				the State attorneys general of the determination.
										(iii)If the
				Secretary determines that such a supplemental application regarding the U.S.
				label drug would be approved, the difference shall be considered to be a
				variation provided for in the approved application for the U.S. label
				drug.
									(E)Notice; drug
				difference not requiring approval; no differenceIn the case of a
				notice under subparagraph (B)(i) that includes a difference for which, under
				section 506A(d)(1)(A), a supplemental application would not be required for the
				difference to be made to the U.S. label drug, or that states that there is no
				difference, the Secretary—
									(i)shall consider
				such difference to be a variation provided for in the approved application for
				the U.S. label drug;
									(ii)may not order
				that the importation of the qualifying drug involved cease; and
									(iii)shall promptly
				notify registered exporters and registered importers.
									(F)Differences in
				active ingredient, route of administration, dosage form, or strength
									(i)In
				generalA person who manufactures a drug approved under section
				505(b) shall submit an application under section 505(b) for approval of another
				drug that is manufactured for distribution in a permitted country by or for the
				person that manufactures the drug approved under section 505(b) if—
										(I)there is no
				qualifying drug in commercial distribution in permitted countries whose
				combined population represents at least 50 percent of the total population of
				all permitted countries with the same active ingredient or ingredients, route
				of administration, dosage form, and strength as the drug approved under section
				505(b); and
										(II)each active
				ingredient of the other drug is related to an active ingredient of the drug
				approved under section 505(b), as defined in clause (v).
										(ii)Application
				under Section 505(b)The
				application under section 505(b) required under clause (i) shall—
										(I)request approval
				of the other drug for the indication or indications for which the drug approved
				under section 505(b) is labeled;
										(II)include the
				information that the person submitted to the government of the permitted
				country for purposes of obtaining approval for commercial distribution of the
				other drug in that country, which if in a language other than English, shall be
				accompanied by an English translation verified to be complete and accurate,
				with the name, address, and a brief statement of the qualifications of the
				person that made the translation;
										(III)include a right
				of reference to the application for the drug approved under section 505(b);
				and
										(IV)include such
				additional information as the Secretary may require.
										(iii)Timing of
				submission of applicationAn application under section 505(b)
				required under clause (i) shall be submitted to the Secretary not later than
				the day on which the information referred to in clause (ii)(II) is submitted to
				the government of the permitted country.
									(iv)Notice of
				decision on applicationThe Secretary shall promptly notify
				registered exporters, registered importers, the Federal Trade Commission, and
				the State attorneys general of a determination to approve or to disapprove an
				application under section 505(b) required under clause (i).
									(v)Related active
				ingredientsFor purposes of clause (i)(II), 2 active ingredients
				are related if they are—
										(I)the same;
				or
										(II)different salts,
				esters, or complexes of the same moiety.
										(3)Section 502;
				labeling
								(A)Importation by
				registered importer
									(i)In
				generalIn the case of a qualifying drug that is imported or
				offered for import by a registered importer, such drug shall be considered to
				be in compliance with section 502 and the labeling requirements under the
				approved application for the U.S. label drug if the qualifying drug
				bears—
										(I)a copy of the
				labeling approved for the U.S. label drug under section 505, without regard to
				whether the copy bears any trademark involved;
										(II)the name of the
				manufacturer and location of the manufacturer;
										(III)the lot number
				assigned by the manufacturer;
										(IV)the name,
				location, and registration number of the importer; and
										(V)the National Drug
				Code number assigned to the qualifying drug by the Secretary.
										(ii)Request for
				copy of the labelingThe Secretary shall provide such copy to the
				registered importer involved, upon request of the importer.
									(iii)Requested
				labelingThe labeling provided by the Secretary under clause (ii)
				shall—
										(I)include the
				established name, as defined in section 502(e)(3), for each active ingredient
				in the qualifying drug;
										(II)not include the
				proprietary name of the U.S. label drug or any active ingredient
				thereof;
										(III)if required
				under paragraph (2)(B)(vi)(III), a prominent advisory that the qualifying drug
				is safe and effective but not bioequivalent to the U.S. label drug; and
										(IV)if the inactive
				ingredients of the qualifying drug are different from the inactive ingredients
				for the U.S. label drug, include—
											(aa)a
				prominent notice that the ingredients of the qualifying drug differ from the
				ingredients of the U.S. label drug and that the qualifying drug must be
				dispensed with an advisory to people with allergies about this difference and a
				list of ingredients; and
											(bb)a
				list of the ingredients of the qualifying drug as would be required under
				section 502(e).
											(B)Importation by
				individual
									(i)In
				generalIn the case of a qualifying drug that is imported or
				offered for import by a registered exporter to an individual, such drug shall
				be considered to be in compliance with section 502 and the labeling
				requirements under the approved application for the U.S. label drug if the
				packaging and labeling of the qualifying drug complies with all applicable
				regulations promulgated under sections 3 and 4 of the Poison Prevention
				Packaging Act of 1970 (15 U.S.C. 1471 et seq.) and the labeling of the
				qualifying drug includes—
										(I)directions for
				use by the consumer;
										(II)the lot number
				assigned by the manufacturer;
										(III)the name and
				registration number of the exporter;
										(IV)if required
				under paragraph (2)(B)(vi)(III), a prominent advisory that the drug is safe and
				effective but not bioequivalent to the U.S. label drug;
										(V)if the inactive
				ingredients of the drug are different from the inactive ingredients for the
				U.S. label drug—
											(aa)a
				prominent advisory that persons with an allergy should check the ingredient
				list of the drug because the ingredients of the drug differ from the
				ingredients of the U.S. label drug; and
											(bb)a
				list of the ingredients of the drug as would be required under section 502(e);
				and
											(VI)a copy of any
				special labeling that would be required by the Secretary had the U.S. label
				drug been dispensed by a pharmacist in the United States, without regard to
				whether the special labeling bears any trademark involved.
										(ii)PackagingA
				qualifying drug offered for import to an individual by an exporter under this
				section that is packaged in a unit-of-use container (as those items are defined
				in the United States Pharmacopeia and National Formulary) shall not be
				repackaged, provided that—
										(I)the packaging
				complies with all applicable regulations under sections 3 and 4 of the Poison
				Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.); or
										(II)the consumer
				consents to waive the requirements of such Act, after being informed that the
				packaging does not comply with such Act and that the exporter will provide the
				drug in packaging that is compliant at no additional cost.
										(iii)Request for
				copy of special labeling and ingredient listThe Secretary shall
				provide to the registered exporter involved a copy of the special labeling, the
				advisory, and the ingredient list described under clause (i), upon request of
				the exporter.
									(iv)Requested
				labeling and ingredient listThe labeling and ingredient list
				provided by the Secretary under clause (iii) shall—
										(I)include the
				established name, as defined in section 502(e)(3), for each active ingredient
				in the drug; and
										(II)not include the
				proprietary name of the U.S. label drug or any active ingredient
				thereof.
										(4)Section 501;
				adulterationA qualifying drug that is imported or offered for
				import under subsection (a) shall be considered to be in compliance with
				section 501 if the drug is in compliance with subsection (c).
							(5)Standards for
				refusing admissionA drug exported under subsection (a) from a
				registered exporter or imported by a registered importer may be refused
				admission into the United States if 1 or more of the following applies:
								(A)The drug is not a
				qualifying drug.
								(B)A notice for the
				drug required under paragraph (2)(B) has not been submitted to the
				Secretary.
								(C)The Secretary has
				ordered that importation of the drug from the permitted country cease under
				subparagraph (C) or (D) of paragraph (2).
								(D)The drug does not
				comply with paragraph (3) or (4).
								(E)The shipping
				container appears damaged in a way that may affect the strength, quality, or
				purity of the drug.
								(F)The Secretary
				becomes aware that—
									(i)the drug may be
				counterfeit;
									(ii)the drug may
				have been prepared, packed, or held under insanitary conditions; or
									(iii)the methods
				used in, or the facilities or controls used for, the manufacturing, processing,
				packing, or holding of the drug do not conform to good manufacturing
				practice.
									(G)The Secretary has
				obtained an injunction under section 302 that prohibits the distribution of the
				drug in interstate commerce.
								(H)The Secretary has
				under section 505(e) withdrawn approval of the drug.
								(I)The manufacturer
				of the drug has instituted a recall of the drug.
								(J)If the drug is
				imported or offered for import by a registered importer without submission of a
				notice in accordance with subsection (d)(4).
								(K)If the drug is
				imported or offered for import from a registered exporter to an individual and
				1 or more of the following applies:
									(i)The shipping
				container for such drug does not bear the markings required under subsection
				(d)(2).
									(ii)The markings on
				the shipping container appear to be counterfeit.
									(iii)The shipping
				container or markings appear to have been tampered with.
									(h)Exporter
				licensure in permitted countryA registration condition is that
				the exporter involved agrees that a qualifying drug will be exported to an
				individual only if the Secretary has verified that—
							(1)the exporter is
				authorized under the law of the permitted country in which the exporter is
				located to dispense prescription drugs; and
							(2)the exporter
				employs persons that are licensed under the law of the permitted country in
				which the exporter is located to dispense prescription drugs in sufficient
				number to dispense safely the drugs exported by the exporter to individuals,
				and the exporter assigns to those persons responsibility for dispensing such
				drugs to individuals.
							(i)Individuals;
				conditions for importation
							(1)In
				generalFor purposes of subsection (a)(2)(B), the importation of
				a qualifying drug by an individual is in accordance with this subsection if the
				following conditions are met:
								(A)The drug is
				accompanied by a copy of a prescription for the drug, which
				prescription—
									(i)is valid under
				applicable Federal and State laws; and
									(ii)was issued by a
				practitioner who, under the law of a State of which the individual is a
				resident, or in which the individual receives care from the practitioner who
				issues the prescription, is authorized to administer prescription drugs.
									(B)The drug is
				accompanied by a copy of the documentation that was required under the law or
				regulations of the permitted country in which the exporter is located, as a
				condition of dispensing the drug to the individual.
								(C)The copies
				referred to in subparagraphs (A)(i) and (B) are marked in a manner
				sufficient—
									(i)to indicate that
				the prescription, and the equivalent document in the permitted country in which
				the exporter is located, have been filled; and
									(ii)to prevent a
				duplicative filling by another pharmacist.
									(D)The individual
				has provided to the registered exporter a complete list of all drugs used by
				the individual for review by the individuals who dispense the drug.
								(E)The quantity of
				the drug does not exceed a 90-day supply.
								(F)The drug is not
				an ineligible subpart H drug. For purposes of this section, a prescription drug
				is an ineligible subpart H drug if the drug was approved by the
				Secretary under subpart H of part 314 of title 21, Code of Federal Regulations
				(relating to accelerated approval), with restrictions under section 520 of such
				part to assure safe use, and the Secretary has published in the Federal
				Register a notice that the Secretary has determined that good cause exists to
				prohibit the drug from being imported pursuant to this subsection.
								(2)Notice
				regarding drug refused admissionIf a registered exporter ships a
				drug to an individual pursuant to subsection (a)(2)(B) and the drug is refused
				admission to the United States, a written notice shall be sent to the
				individual and to the exporter that informs the individual and the exporter of
				such refusal and the reason for the refusal.
							(j)Maintenance of
				records and samples
							(1)In
				generalA registration condition is that the importer or exporter
				involved shall—
								(A)maintain records
				required under this section for not less than 2 years; and
								(B)maintain samples
				of each lot of a qualifying drug required under this section for not more than
				2 years.
								(2)Place of record
				maintenanceThe records described under paragraph (1) shall be
				maintained—
								(A)in the case of an
				importer, at the place of business of the importer at which the importer
				initially receives the qualifying drug after importation; or
								(B)in the case of an
				exporter, at the facility from which the exporter ships the qualifying drug to
				the United States.
								(k)Drug
				recalls
							(1)ManufacturersA
				person that manufactures a qualifying drug imported from a permitted country
				under this section shall promptly inform the Secretary—
								(A)if the drug is
				recalled or withdrawn from the market in a permitted country;
								(B)how the drug may
				be identified, including lot number; and
								(C)the reason for
				the recall or withdrawal.
								(2)SecretaryWith
				respect to each permitted country, the Secretary shall—
								(A)enter into an
				agreement with the government of the country to receive information about
				recalls and withdrawals of qualifying drugs in the country; or
								(B)monitor recalls
				and withdrawals of qualifying drugs in the country using any information that
				is available to the public in any media.
								(3)NoticeThe
				Secretary may notify, as appropriate, registered exporters, registered
				importers, wholesalers, pharmacies, or the public of a recall or withdrawal of
				a qualifying drug in a permitted country.
							(l)Drug labeling
				and packaging
							(1)In
				generalWhen a qualifying drug that is imported into the United
				States by an importer under subsection (a) is dispensed by a pharmacist to an
				individual, the pharmacist shall provide that the packaging and labeling of the
				drug complies with all applicable regulations promulgated under sections 3 and
				4 of the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.) and
				shall include with any other labeling provided to the individual the
				following:
								(A)The lot number
				assigned by the manufacturer.
								(B)The name and
				registration number of the importer.
								(C)If required under
				paragraph (2)(B)(vi)(III) of subsection (g), a prominent advisory that the drug
				is safe and effective but not bioequivalent to the U.S. label drug.
								(D)If the inactive
				ingredients of the drug are different from the inactive ingredients for the
				U.S. label drug—
									(i)a
				prominent advisory that persons with allergies should check the ingredient list
				of the drug because the ingredients of the drug differ from the ingredients of
				the U.S. label drug; and
									(ii)a list of the
				ingredients of the drug as would be required under section 502(e).
									(2)PackagingA
				qualifying drug that is packaged in a unit-of-use container (as those terms are
				defined in the United States Pharmacopeia and National Formulary) shall not be
				repackaged, provided that—
								(A)the packaging
				complies with all applicable regulations under sections 3 and 4 of the Poison
				Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.); or
								(B)the consumer
				consents to waive the requirements of such Act, after being informed that the
				packaging does not comply with such Act and that the pharmacist will provide
				the drug in packaging that is compliant at no additional cost.
								(m)Charitable
				contributionsNotwithstanding any other provision of this
				section, this section does not authorize the importation into the United States
				of a qualifying drug donated or otherwise supplied for free or at nominal cost
				by the manufacturer of the drug to a charitable or humanitarian organization,
				including the United Nations and affiliates, or to a government of a foreign
				country.
						(n)Unfair and
				discriminatory Acts and practices
							(1)In
				generalIt is unlawful for a manufacturer, directly or indirectly
				(including by being a party to a licensing agreement or other agreement),
				to—
								(A)discriminate by
				charging a higher price for a prescription drug sold to a registered exporter
				or other person in a permitted country that exports a qualifying drug to the
				United States under this section than the price that is charged, inclusive of
				rebates or other incentives to the permitted country or other person, to
				another person that is in the same country and that does not export a
				qualifying drug into the United States under this section;
								(B)discriminate by
				charging a higher price for a prescription drug sold to a registered importer
				or other person that distributes, sells, or uses a qualifying drug imported
				into the United States under this section than the price that is charged to
				another person in the United States that does not import a qualifying drug
				under this section, or that does not distribute, sell, or use such a
				drug;
								(C)discriminate by
				denying, restricting, or delaying supplies of a prescription drug to a
				registered exporter or other person in a permitted country that exports a
				qualifying drug to the United States under this section or to a registered
				importer or other person that distributes, sells, or uses a qualifying drug
				imported into the United States under this section;
								(D)discriminate by
				publicly, privately, or otherwise refusing to do business with a registered
				exporter or other person in a permitted country that exports a qualifying drug
				to the United States under this section or with a registered importer or other
				person that distributes, sells, or uses a qualifying drug imported into the
				United States under this section;
								(E)knowingly fail to
				submit a notice under subsection (g)(2)(B)(i), knowingly fail to submit such a
				notice on or before the date specified in subsection (g)(2)(B)(v) or as
				otherwise required under paragraphs (3), (4), and (5) of section 4(e) of the
				Pharmaceutical Market Access and Drug Safety
				Act of 2011, knowingly submit such a notice that makes a
				materially false, fictitious, or fraudulent statement, or knowingly fail to
				provide promptly any information requested by the Secretary to review such a
				notice;
								(F)knowingly fail to
				submit an application required under subsection (g)(2)(F), knowingly fail to
				submit such an application on or before the date specified in subsection
				(g)(2)(F)(iii), knowingly submit such an application that makes a materially
				false, fictitious, or fraudulent statement, or knowingly fail to provide
				promptly any information requested by the Secretary to review such an
				application;
								(G)cause there to be
				a difference (including a difference in active ingredient, route of
				administration, dosage form, strength, formulation, manufacturing
				establishment, manufacturing process, or person that manufactures the drug)
				between a prescription drug for distribution in the United States and the drug
				for distribution in a permitted country;
								(H)refuse to allow
				an inspection authorized under this section of an establishment that
				manufactures a qualifying drug that is, or will be, introduced for commercial
				distribution in a permitted country;
								(I)fail to conform
				to the methods used in, or the facilities used for, the manufacturing,
				processing, packing, or holding of a qualifying drug that is, or will be,
				introduced for commercial distribution in a permitted country to good
				manufacturing practice under this Act;
								(J)become a party to
				a licensing agreement or other agreement related to a qualifying drug that
				fails to provide for compliance with all requirements of this section with
				respect to such drug;
								(K)enter into a
				contract that restricts, prohibits, or delays the importation of a qualifying
				drug under this section;
								(L)engage in any
				other action to restrict, prohibit, or delay the importation of a qualifying
				drug under this section; or
								(M)engage in any
				other action that the Federal Trade Commission determines to discriminate
				against a person that engages or attempts to engage in the importation of a
				qualifying drug under this section.
								(2)Referral of
				potential violationsThe Secretary shall promptly refer to the
				Federal Trade Commission each potential violation of subparagraph (E), (F),
				(G), (H), or (I) of paragraph (1) that becomes known to the Secretary.
							(3)Affirmative
				defense
								(A)DiscriminationIt
				shall be an affirmative defense to a charge that a manufacturer has
				discriminated under subparagraph (A), (B), (C), (D), or (M) of paragraph (1)
				that the higher price charged for a prescription drug sold to a person, the
				denial, restriction, or delay of supplies of a prescription drug to a person,
				the refusal to do business with a person, or other discriminatory activity
				against a person, is not based, in whole or in part, on—
									(i)the person
				exporting or importing a qualifying drug into the United States under this
				section; or
									(ii)the person
				distributing, selling, or using a qualifying drug imported into the United
				States under this section.
									(B)Drug
				differencesIt shall be an affirmative defense to a charge that a
				manufacturer has caused there to be a difference described in subparagraph (G)
				of paragraph (1) that—
									(i)the difference
				was required by the country in which the drug is distributed;
									(ii)the Secretary
				has determined that the difference was necessary to improve the safety or
				effectiveness of the drug;
									(iii)the person
				manufacturing the drug for distribution in the United States has given notice
				to the Secretary under subsection (g)(2)(B)(i) that the drug for distribution
				in the United States is not different from a drug for distribution in permitted
				countries whose combined population represents at least 50 percent of the total
				population of all permitted countries; or
									(iv)the difference
				was not caused, in whole or in part, for the purpose of restricting importation
				of the drug into the United States under this section.
									(4)Effect of
				subsection
								(A)Sales in other
				countriesThis subsection applies only to the sale or
				distribution of a prescription drug in a country if the manufacturer of the
				drug chooses to sell or distribute the drug in the country. Nothing in this
				subsection shall be construed to compel the manufacturer of a drug to
				distribute or sell the drug in a country.
								(B)Discounts to
				insurers, health plans, pharmacy benefit managers, and covered
				entitiesNothing in this subsection shall be construed to—
									(i)prevent or
				restrict a manufacturer of a prescription drug from providing discounts to an
				insurer, health plan, pharmacy benefit manager in the United States, or covered
				entity in the drug discount program under section 340B of the
				Public Health Service Act (42 U.S.C.
				256b) in return for inclusion of the drug on a formulary;
									(ii)require that
				such discounts be made available to other purchasers of the prescription drug;
				or
									(iii)prevent or
				restrict any other measures taken by an insurer, health plan, or pharmacy
				benefit manager to encourage consumption of such prescription drug.
									(C)Charitable
				contributionsNothing in this subsection shall be construed
				to—
									(i)prevent a
				manufacturer from donating a prescription drug, or supplying a prescription
				drug at nominal cost, to a charitable or humanitarian organization, including
				the United Nations and affiliates, or to a government of a foreign country;
				or
									(ii)apply to such
				donations or supplying of a prescription drug.
									(5)Enforcement
								(A)Unfair or
				deceptive Act or practiceA violation of this subsection shall be
				treated as a violation of a rule defining an unfair or deceptive act or
				practice prescribed under section 18(a)(1)(B) of the
				Federal Trade Commission Act (15
				U.S.C. 57a(a)(1)(B)).
								(B)Actions by the
				commissionThe Federal Trade Commission—
									(i)shall enforce
				this subsection in the same manner, by the same means, and with the same
				jurisdiction, powers, and duties as though all applicable terms and provisions
				of the Federal Trade Commission Act
				(15 U.S.C. 41 et seq.) were incorporated into and made a part of this section;
				and
									(ii)may seek
				monetary relief threefold the damages sustained, in addition to any other
				remedy available to the Federal Trade Commission under the
				Federal Trade Commission Act (15
				U.S.C. 41 et seq.).
									(6)Actions by
				States
								(A)In
				general
									(i)Civil
				actionsIn any case in which the attorney general of a State has
				reason to believe that an interest of the residents of that State have been
				adversely affected by any manufacturer that violates paragraph (1), the
				attorney general of a State may bring a civil action on behalf of the residents
				of the State, and persons doing business in the State, in a district court of
				the United States of appropriate jurisdiction to—
										(I)enjoin that
				practice;
										(II)enforce
				compliance with this subsection;
										(III)obtain damages,
				restitution, or other compensation on behalf of residents of the State and
				persons doing business in the State, including threefold the damages; or
										(IV)obtain such
				other relief as the court may consider to be appropriate.
										(ii)Notice
										(I)In
				generalBefore filing an action under clause (i), the attorney
				general of the State involved shall provide to the Federal Trade
				Commission—
											(aa)written notice
				of that action; and
											(bb)a
				copy of the complaint for that action.
											(II)ExemptionSubclause
				(I) shall not apply with respect to the filing of an action by an attorney
				general of a State under this paragraph, if the attorney general determines
				that it is not feasible to provide the notice described in that subclause
				before filing of the action. In such case, the attorney general of a State
				shall provide notice and a copy of the complaint to the Federal Trade
				Commission at the same time as the attorney general files the action.
										(B)Intervention
									(i)In
				generalOn receiving notice under subparagraph (A)(ii), the
				Federal Trade Commission shall have the right to intervene in the action that
				is the subject of the notice.
									(ii)Effect of
				interventionIf the Federal Trade Commission intervenes in an
				action under subparagraph (A), it shall have the right—
										(I)to be heard with
				respect to any matter that arises in that action; and
										(II)to file a
				petition for appeal.
										(C)ConstructionFor
				purposes of bringing any civil action under subparagraph (A), nothing in this
				subsection shall be construed to prevent an attorney general of a State from
				exercising the powers conferred on the attorney general by the laws of that
				State to—
									(i)conduct
				investigations;
									(ii)administer oaths
				or affirmations; or
									(iii)compel the
				attendance of witnesses or the production of documentary and other
				evidence.
									(D)Actions by the
				commissionIn any case in which an action is instituted by or on
				behalf of the Federal Trade Commission for a violation of paragraph (1), a
				State may not, during the pendency of that action, institute an action under
				subparagraph (A) for the same violation against any defendant named in the
				complaint in that action.
								(E)VenueAny
				action brought under subparagraph (A) may be brought in the district court of
				the United States that meets applicable requirements relating to venue under
				section 1391 of title 28, United States Code.
								(F)Service of
				processIn an action brought under subparagraph (A), process may
				be served in any district in which the defendant—
									(i)is an inhabitant;
				or
									(ii)may be
				found.
									(G)Measurement of
				damagesIn any action under this paragraph to enforce a cause of
				action under this subsection in which there has been a determination that a
				defendant has violated a provision of this subsection, damages may be proved
				and assessed in the aggregate by statistical or sampling methods, by the
				computation of illegal overcharges or by such other reasonable system of
				estimating aggregate damages as the court in its discretion may permit without
				the necessity of separately proving the individual claim of, or amount of
				damage to, persons on whose behalf the suit was brought.
								(H)Exclusion on
				duplicative reliefThe district court shall exclude from the
				amount of monetary relief awarded in an action under this paragraph brought by
				the attorney general of a State any amount of monetary relief which duplicates
				amounts which have been awarded for the same injury.
								(7)Effect on
				antitrust lawsNothing in this subsection shall be construed to
				modify, impair, or supersede the operation of the antitrust laws. For the
				purpose of this subsection, the term antitrust laws has the
				meaning given it in the first section of the Clayton Act, except that it includes section 5
				of the Federal Trade Commission Act
				to the extent that such section 5 applies to unfair methods of
				competition.
							(8)ManufacturerIn
				this subsection, the term manufacturer means any entity, including
				any affiliate or licensee of that entity, that is engaged in—
								(A)the production,
				preparation, propagation, compounding, conversion, or processing of a
				prescription drug, either directly or indirectly by extraction from substances
				of natural origin, or independently by means of chemical synthesis, or by a
				combination of extraction and chemical synthesis; or
								(B)the packaging,
				repackaging, labeling, relabeling, or distribution of a prescription
				drug.
								.
			(b)Prohibited
			 ActsThe Federal Food, Drug, and
			 Cosmetic Act is amended—
				(1)in section 301
			 (21 U.S.C. 331), by striking paragraph (aa) and inserting the following:

						(aa)(1)The sale or trade by a
				pharmacist, or by a business organization of which the pharmacist is a part, of
				a qualifying drug that under section 804(a)(2)(A) was imported by the
				pharmacist, other than—
								(A)a sale at retail made pursuant to
				dispensing the drug to a customer of the pharmacist or organization; or
								(B)a sale or trade of the drug to a
				pharmacy or a wholesaler registered to import drugs under section 804.
								(2)The sale or trade by an individual of
				a qualifying drug that under section 804(a)(2)(B) was imported by the
				individual.
							(3)The making of a materially false,
				fictitious, or fraudulent statement or representation, or a material omission,
				in a notice under clause (i) of section 804(g)(2)(B) or in an application
				required under section 804(g)(2)(F), or the failure to submit such a notice or
				application.
							(4)The importation of a drug in
				violation of a registration condition or other requirement under section 804,
				the falsification of any record required to be maintained, or provided to the
				Secretary, under such section, or the violation of any registration condition
				or other requirement under such
				section.
							;
				and
				(2)in section 303(a)
			 (21 U.S.C. 333(a)), by striking paragraph (6) and inserting the
			 following:

						(6)Notwithstanding subsection (a), any
				person that knowingly violates section 301(i) (2) or (3) or section 301(aa)(4)
				shall be imprisoned not more than 10 years, or fined in accordance with title
				18, United States Code, or
				both.
						.
				(c)Amendment of
			 certain provisions
				(1)In
			 generalSection 801 of the Federal Food, Drug, and Cosmetic Act (21
			 U.S.C. 381) is amended by striking subsection (g) and inserting the
			 following:

						(g)With respect to a
				prescription drug that is imported or offered for import into the United States
				by an individual who is not in the business of such importation, that is not
				shipped by a registered exporter under section 804, and that is refused
				admission under subsection (a), the Secretary shall notify the individual
				that—
							(1)the drug has been
				refused admission because the drug was not a lawful import under section
				804;
							(2)the drug is not
				otherwise subject to a waiver of the requirements of subsection (a);
							(3)the individual
				may under section 804 lawfully import certain prescription drugs from exporters
				registered with the Secretary under section 804; and
							(4)the individual
				can find information about such importation, including a list of registered
				exporters, on the Internet website of the Food and Drug Administration or
				through a toll-free telephone number required under section
				804.
							.
				(2)Establishment
			 registrationSection 510(i) of the
			 Federal Food, Drug, and Cosmetic Act
			 (21 U.S.C. 360(i)) is amended in paragraph (1) by inserting after import
			 into the United States the following: , including a drug that
			 is, or may be, imported or offered for import into the United States under
			 section 804,.
				(3)Effective
			 dateThe amendments made by this subsection shall take effect on
			 the date that is 90 days after the date of enactment of this Act.
				(d)Exhaustion
				(1)In
			 generalSection 271 of title 35, United States Code, is
			 amended—
					(A)by redesignating
			 subsections (h) and (i) as (i) and (j), respectively; and
					(B)by inserting
			 after subsection (g) the following:

							(h)It shall not be
				an act of infringement to use, offer to sell, or sell within the United States
				or to import into the United States any patented invention under section 804 of
				the Federal Food, Drug, and Cosmetic
				Act that was first sold abroad by or under authority of the owner or
				licensee of such
				patent.
							.
					(2)Rule of
			 constructionNothing in the amendment made by paragraph (1) shall
			 be construed to affect the ability of a patent owner or licensee to enforce
			 their patent, subject to such amendment.
				(e)Effect of
			 Section 804
				(1)In
			 generalSection 804 of the Federal Food, Drug, and Cosmetic Act, as added
			 by subsection (a), shall permit the importation of qualifying drugs (as defined
			 in such section 804) into the United States without regard to the status of the
			 issuance of implementing regulations—
					(A)from exporters
			 registered under such section 804 on the date that is 90 days after the date of
			 enactment of this Act; and
					(B)from permitted
			 countries, as defined in such section 804, by importers registered under such
			 section 804 on the date that is 1 year after the date of enactment of this
			 Act.
					(2)Review of
			 registration by certain exporters
					(A)Review
			 priorityIn the review of registrations submitted under
			 subsection (b) of such section 804, registrations submitted by entities in
			 Canada that are significant exporters of prescription drugs to individuals in
			 the United States as of the date of enactment of this Act will have priority
			 during the 90 day period that begins on such date of enactment.
					(B)Period for
			 reviewDuring such 90-day period, the reference in subsection
			 (b)(2)(A) of such section 804 to 90 days (relating to approval or disapproval
			 of registrations) is, as applied to such entities, deemed to be 30 days.
					(C)LimitationThat
			 an exporter in Canada exports, or has exported, prescription drugs to
			 individuals in the United States on or before the date that is 90 days after
			 the date of enactment of this Act shall not serve as a basis, in whole or in
			 part, for disapproving a registration under such section 804 from the
			 exporter.
					(D)First year
			 limit on number of exportersDuring the 1-year period beginning
			 on the date of enactment of this Act, the Secretary of Health and Human
			 Services (referred to in this section as the Secretary) may
			 limit the number of registered exporters under such section 804 to not less
			 than 50, so long as the Secretary gives priority to those exporters with
			 demonstrated ability to process a high volume of shipments of drugs to
			 individuals in the United States.
					(E)Second year
			 limit on number of exportersDuring the 1-year period beginning
			 on the date that is 1 year after the date of enactment of this Act, the
			 Secretary may limit the number of registered exporters under such section 804
			 to not less than 100, so long as the Secretary gives priority to those
			 exporters with demonstrated ability to process a high volume of shipments of
			 drugs to individuals in the United States.
					(F)Further limit
			 on number of exportersDuring any 1-year period beginning on a
			 date that is 2 or more years after the date of enactment of this Act, the
			 Secretary may limit the number of registered exporters under such section 804
			 to not less than 25 more than the number of such exporters during the previous
			 1-year period, so long as the Secretary gives priority to those exporters with
			 demonstrated ability to process a high volume of shipments of drugs to
			 individuals in the United States.
					(3)Limits on
			 number of importers
					(A)First year
			 limit on number of importersDuring the 1-year period beginning
			 on the date that is 1 year after the date of enactment of this Act, the
			 Secretary may limit the number of registered importers under such section 804
			 to not less than 100 (of which at least a significant number shall be groups of
			 pharmacies, to the extent feasible given the applications submitted by such
			 groups), so long as the Secretary gives priority to those importers with
			 demonstrated ability to process a high volume of shipments of drugs imported
			 into the United States.
					(B)Second year
			 limit on number of importersDuring the 1-year period beginning
			 on the date that is 2 years after the date of enactment of this Act, the
			 Secretary may limit the number of registered importers under such section 804
			 to not less than 200 (of which at least a significant number shall be groups of
			 pharmacies, to the extent feasible given the applications submitted by such
			 groups), so long as the Secretary gives priority to those importers with
			 demonstrated ability to process a high volume of shipments of drugs into the
			 United States.
					(C)Further limit
			 on number of importersDuring any 1-year period beginning on a
			 date that is 3 or more years after the date of enactment of this Act, the
			 Secretary may limit the number of registered importers under such section 804
			 to not less than 50 more (of which at least a significant number shall be
			 groups of pharmacies, to the extent feasible given the applications submitted
			 by such groups) than the number of such importers during the previous 1-year
			 period, so long as the Secretary gives priority to those importers with
			 demonstrated ability to process a high volume of shipments of drugs to the
			 United States.
					(4)Notices for
			 drugs for import from CanadaThe notice with respect to a
			 qualifying drug introduced for commercial distribution in Canada as of the date
			 of enactment of this Act that is required under subsection (g)(2)(B)(i) of such
			 section 804 shall be submitted to the Secretary not later than 30 days after
			 the date of enactment of this Act if—
					(A)the U.S. label
			 drug (as defined in such section 804) for the qualifying drug is 1 of the 100
			 prescription drugs with the highest dollar volume of sales in the United States
			 based on the 12 calendar month period most recently completed before the date
			 of enactment of this Act; or
					(B)the notice is a
			 notice under subsection (g)(2)(B)(i)(II) of such section 804.
					(5)Notice for
			 drugs for import from other countriesThe notice with respect to
			 a qualifying drug introduced for commercial distribution in a permitted country
			 other than Canada as of the date of enactment of this Act that is required
			 under subsection (g)(2)(B)(i) of such section 804 shall be submitted to the
			 Secretary not later than 180 days after the date of enactment of this Act
			 if—
					(A)the U.S. label
			 drug for the qualifying drug is 1 of the 100 prescription drugs with the
			 highest dollar volume of sales in the United States based on the 12 calendar
			 month period that is first completed on the date that is 120 days after the
			 date of enactment of this Act; or
					(B)the notice is a
			 notice under subsection (g)(2)(B)(i)(II) of such section 804.
					(6)Notice for
			 other drugs for import
					(A)Guidance on
			 submission datesThe Secretary shall by guidance establish a
			 series of submission dates for the notices under subsection (g)(2)(B)(i) of
			 such section 804 with respect to qualifying drugs introduced for commercial
			 distribution as of the date of enactment of this Act and that are not required
			 to be submitted under paragraph (4) or (5).
					(B)Consistent and
			 efficient use of resourcesThe Secretary shall establish the
			 dates described under subparagraph (A) so that such notices described under
			 subparagraph (A) are submitted and reviewed at a rate that allows consistent
			 and efficient use of the resources and staff available to the Secretary for
			 such reviews. The Secretary may condition the requirement to submit such a
			 notice, and the review of such a notice, on the submission by a registered
			 exporter or a registered importer to the Secretary of a notice that such
			 exporter or importer intends to import such qualifying drug to the United
			 States under such section 804.
					(C)Priority for
			 drugs with higher salesThe Secretary shall establish the dates
			 described under subparagraph (A) so that the Secretary reviews the notices
			 described under such subparagraph with respect to qualifying drugs with higher
			 dollar volume of sales in the United States before the notices with respect to
			 drugs with lower sales in the United States.
					(7)Notices for
			 drugs approved after effective dateThe notice required under
			 subsection (g)(2)(B)(i) of such section 804 for a qualifying drug first
			 introduced for commercial distribution in a permitted country (as defined in
			 such section 804) after the date of enactment of this Act shall be submitted to
			 and reviewed by the Secretary as provided under subsection (g)(2)(B) of such
			 section 804, without regard to paragraph (4), (5), or (6).
				(8)ReportBeginning
			 with the first full fiscal year after the date of enactment of this Act, not
			 later than 90 days after the end of each fiscal year during which the Secretary
			 reviews a notice referred to in paragraph (4), (5), or (6), the Secretary shall
			 submit a report to Congress concerning the progress of the Food and Drug
			 Administration in reviewing the notices referred to in paragraphs (4), (5), and
			 (6).
				(9)User
			 fees
					(A)ExportersWhen
			 establishing an aggregate total of fees to be collected from exporters under
			 subsection (f)(2) of such section 804, the Secretary shall, under subsection
			 (f)(3)(C)(i) of such section 804, estimate the total price of drugs imported
			 under subsection (a) of such section 804 into the United States by registered
			 exporters during the first fiscal year in which this Act takes effect to be an
			 amount equal to the amount which bears the same ratio to $1,000,000,000 as the
			 number of days in such fiscal year during which this Act is effective bears to
			 365.
					(B)ImportersWhen
			 establishing an aggregate total of fees to be collected from importers under
			 subsection (e)(2) of such section 804, the Secretary shall, under subsection
			 (e)(3)(C)(i) of such section 804, estimate the total price of drugs imported
			 under subsection (a) of such section 804 into the United States by registered
			 importers during—
						(i)the
			 first fiscal year in which this Act takes effect to be an amount equal to the
			 amount which bears the same ratio to $1,000,000,000 as the number of days in
			 such fiscal year during which this Act is effective bears to 365; and
						(ii)the second
			 fiscal year in which this Act is in effect to be $3,000,000,000.
						(C)Second year
			 adjustment
						(i)ReportsNot
			 later than February 20 of the second fiscal year in which this Act is in
			 effect, registered importers shall report to the Secretary the total price and
			 the total volume of drugs imported to the United States by the importer during
			 the 4-month period from October 1 through January 31 of such fiscal
			 year.
						(ii)ReestimateNotwithstanding
			 subsection (e)(3)(C)(ii) of such section 804 or subparagraph (B), the Secretary
			 shall reestimate the total price of qualifying drugs imported under subsection
			 (a) of such section 804 into the United States by registered importers during
			 the second fiscal year in which this Act is in effect. Such reestimate shall be
			 equal to—
							(I)the total price
			 of qualifying drugs imported by each importer as reported under clause (i);
			 multiplied by
							(II)3.
							(iii)AdjustmentThe
			 Secretary shall adjust the fee due on April 1 of the second fiscal year in
			 which this Act is in effect, from each importer so that the aggregate total of
			 fees collected under subsection (e)(2) for such fiscal year does not exceed the
			 total price of qualifying drugs imported under subsection (a) of such section
			 804 into the United States by registered importers during such fiscal year as
			 reestimated under clause (ii).
						(D)Failure to pay
			 feesNotwithstanding any other provision of this section, the
			 Secretary may prohibit a registered importer or exporter that is required to
			 pay user fees under subsection (e) or (f) of such section 804 and that fails to
			 pay such fees within 30 days after the date on which it is due, from importing
			 or offering for importation a qualifying drug under such section 804 until such
			 fee is paid.
					(E)Annual
			 report
						(i)Food and Drug
			 AdministrationNot later than 180 days after the end of each
			 fiscal year during which fees are collected under subsection (e), (f), or
			 (g)(2)(B)(iv) of such section 804, the Secretary shall prepare and submit to
			 the House of Representatives and the Senate a report on the implementation of
			 the authority for such fees during such fiscal year and the use, by the Food
			 and Drug Administration, of the fees collected for the fiscal year for which
			 the report is made and credited to the Food and Drug Administration.
						(ii)Customs and
			 Border ProtectionNot later than 180 days after the end of each
			 fiscal year during which fees are collected under subsection (e) or (f) of such
			 section 804, the Secretary of Homeland Security, in consultation with the
			 Secretary of the Treasury, shall prepare and submit to the House of
			 Representatives and the Senate a report on the use, by the Bureau of Customs
			 and Border Protection, of the fees, if any, transferred by the Secretary to the
			 Bureau of Customs and Border Protection for the fiscal year for which the
			 report is made.
						(10)Special rule
			 regarding importation by individuals
					(A)In
			 generalNotwithstanding any provision of this Act (or an
			 amendment made by this Act), the Secretary shall expedite the designation of
			 any additional permitted countries from which an individual may import a
			 qualifying drug into the United States under such section 804 if any action
			 implemented by the Government of Canada has the effect of limiting or
			 prohibiting the importation of qualifying drugs into the United States from
			 Canada.
					(B)Timing and
			 criteriaThe Secretary shall designate such additional permitted
			 countries under subparagraph (A)—
						(i)not
			 later than 6 months after the date of the action by the Government of Canada
			 described under such subparagraph; and
						(ii)using the
			 criteria described under subsection (a)(4)(D)(i)(II) of such section
			 804.
						(f)Implementation
			 of Section 804
				(1)Interim
			 ruleThe Secretary may promulgate an interim rule for
			 implementing section 804 of the Federal Food,
			 Drug, and Cosmetic Act, as added by subsection (a) of this
			 section.
				(2)No notice of
			 proposed rulemakingThe interim rule described under paragraph
			 (1) may be developed and promulgated by the Secretary without providing general
			 notice of proposed rulemaking.
				(3)Final
			 ruleNot later than 1 year after the date on which the Secretary
			 promulgates an interim rule under paragraph (1), the Secretary shall, in
			 accordance with procedures under section 553 of title 5, United States Code,
			 promulgate a final rule for implementing such section 804, which may
			 incorporate by reference provisions of the interim rule provided for under
			 paragraph (1), to the extent that such provisions are not modified.
				(g)Consumer
			 educationThe Secretary shall carry out activities that educate
			 consumers—
				(1)with regard to
			 the availability of qualifying drugs for import for personal use from an
			 exporter registered with and approved by the Food and Drug Administration under
			 section 804 of the Federal Food, Drug, and
			 Cosmetic Act, as added by this section, including information on how
			 to verify whether an exporter is registered and approved by use of the Internet
			 website of the Food and Drug Administration and the toll-free telephone number
			 required by this Act;
				(2)that drugs that
			 consumers attempt to import from an exporter that is not registered with and
			 approved by the Food and Drug Administration can be seized by the United States
			 Customs Service and destroyed, and that such drugs may be counterfeit,
			 unapproved, unsafe, or ineffective;
				(3)with regard to
			 the suspension and termination of any registration of a registered importer or
			 exporter under such section 804; and
				(4)with regard to
			 the availability at domestic retail pharmacies of qualifying drugs imported
			 under such section 804 by domestic wholesalers and pharmacies registered with
			 and approved by the Food and Drug Administration.
				(h)Effect on
			 administration practicesNotwithstanding any provision of this
			 Act (and the amendments made by this Act), the practices and policies of the
			 Food and Drug Administration and Bureau of Customs and Border Protection, in
			 effect on January 1, 2004, with respect to the importation of prescription
			 drugs into the United States by an individual, on the person of such
			 individual, for personal use, shall remain in effect.
			(i)Report to
			 CongressThe Federal Trade Commission shall, on an annual basis,
			 submit to Congress a report that describes any action taken during the period
			 for which the report is being prepared to enforce the provisions of section
			 804(n) of the Federal Food, Drug, and Cosmetic Act (as added by this Act),
			 including any pending investigations or civil actions under such
			 section.
			5.Disposition of
			 certain drugs denied admission into United States
			(a)In
			 generalChapter VIII of the Federal Food, Drug, and Cosmetic Act (21
			 U.S.C. 381 et seq.), as amended by section 4, is further amended by adding at
			 the end the following section:

					805.Disposition of
				certain drugs denied admission
						(a)In
				generalThe Secretary of Homeland Security shall deliver to the
				Secretary a shipment of drugs that is imported or offered for import into the
				United States if—
							(1)the shipment has
				a declared value of less than $10,000; and
							(2)(A)the shipping container
				for such drugs does not bear the markings required under section 804(d)(2);
				or
								(B)the Secretary has requested delivery
				of such shipment of drugs.
								(b)No bond or
				exportSection 801(b) does not authorize the delivery to the
				owner or consignee of drugs delivered to the Secretary under subsection (a)
				pursuant to the execution of a bond, and such drugs may not be exported.
						(c)Destruction of
				violative shipmentThe Secretary shall destroy a shipment of
				drugs delivered by the Secretary of Homeland Security to the Secretary under
				subsection (a) if—
							(1)in the case of
				drugs that are imported or offered for import from a registered exporter under
				section 804, the drugs are in violation of any standard described in section
				804(g)(5); or
							(2)in the case of
				drugs that are not imported or offered for import from a registered exporter
				under section 804, the drugs are in violation of a standard referred to in
				section 801(a) or 801(d)(1).
							(d)Certain
				procedures
							(1)In
				generalThe delivery and destruction of drugs under this section
				may be carried out without notice to the importer, owner, or consignee of the
				drugs except as required by section 801(g) or section 804(i)(2). The issuance
				of receipts for the drugs, and recordkeeping activities regarding the drugs,
				may be carried out on a summary basis.
							(2)Objective of
				proceduresProcedures promulgated under paragraph (1) shall be
				designed toward the objective of ensuring that, with respect to efficiently
				utilizing Federal resources available for carrying out this section, a
				substantial majority of shipments of drugs subject to described in subsection
				(c) are identified and destroyed.
							(e)Evidence
				exceptionDrugs may not be destroyed under subsection (c) to the
				extent that the Attorney General of the United States determines that the drugs
				should be preserved as evidence or potential evidence with respect to an
				offense against the United States.
						(f)Rule of
				constructionThis section may not be construed as having any
				legal effect on applicable law with respect to a shipment of drugs that is
				imported or offered for import into the United States and has a declared value
				equal to or greater than
				$10,000.
						.
			(b)ProceduresProcedures
			 for carrying out section 805 of the Federal
			 Food, Drug, and Cosmetic Act, as added by subsection (a), shall be
			 established not later than 90 days after the date of the enactment of this
			 Act.
			(c)Effective
			 dateThe amendments made by this section shall take effect on the
			 date that is 90 days after the date of enactment of this Act.
			6.Wholesale
			 distribution of drugs; statements regarding prior sale, purchase, or
			 trade
			(a)Striking of
			 exemptions; applicability to registered exportersSection 503(e)
			 of the Federal Food, Drug, and Cosmetic
			 Act (21 U.S.C. 353(e)) is amended—
				(1)in paragraph
			 (1)—
					(A)by striking
			 and who is not the manufacturer or an authorized distributor of record
			 of such drug;
					(B)by striking
			 to an authorized distributor of record or; and
					(C)by striking
			 subparagraph (B) and inserting the following:

							(B)The fact that a drug subject to
				subsection (b) is exported from the United States does not with respect to such
				drug exempt any person that is engaged in the business of the wholesale
				distribution of the drug from providing the statement described in subparagraph
				(A) to the person that receives the drug pursuant to the export of the
				drug.
							(C)(i)The Secretary shall by
				regulation establish requirements that supersede subparagraph (A) (referred to
				in this subparagraph as alternative requirements) to identify
				the chain of custody of a drug subject to subsection (b) from the manufacturer
				of the drug throughout the wholesale distribution of the drug to a pharmacist
				who intends to sell the drug at retail if the Secretary determines that the
				alternative requirements, which may include standardized anti-counterfeiting or
				track-and-trace technologies, will identify such chain of custody or the
				identity of the discrete package of the drug from which the drug is dispensed
				with equal or greater certainty to the requirements of subparagraph (A), and
				that the alternative requirements are economically and technically
				feasible.
								(ii)When the Secretary promulgates a
				final rule to establish such alternative requirements, the final rule in
				addition shall, with respect to the registration condition established in
				clause (i) of section 804(c)(3)(B), establish a condition equivalent to the
				alternative requirements, and such equivalent condition may be met in lieu of
				the registration condition established in such clause
				(i).
								;
					(2)in paragraph
			 (2)(A), by adding at the end the following: The preceding sentence may
			 not be construed as having any applicability with respect to a registered
			 exporter under section 804.; and
				(3)in paragraph (3),
			 by striking and subsection (d)— in the matter preceding
			 subparagraph (A) and all that follows through the term wholesale
			 distribution means in subparagraph (B) and inserting the
			 following: and subsection (d), the term wholesale
			 distribution means.
				(b)Conforming
			 amendmentSection 503(d) of the Federal Food, Drug, and Cosmetic Act (21
			 U.S.C. 353(d)) is amended by adding at the end the following:

					(4)Each manufacturer of a drug subject
				to subsection (b) shall maintain at its corporate offices a current list of the
				authorized distributors of record of such drug.
					(5)For purposes of this subsection, the
				term authorized distributors of record means those distributors
				with whom a manufacturer has established an ongoing relationship to distribute
				such manufacturer’s
				products.
					.
			(c)Effective
			 date
				(1)In
			 generalThe amendments made by paragraphs (1) and (3) of
			 subsection (a) and by subsection (b) shall take effect on January 1,
			 2013.
				(2)Drugs imported
			 by registered importers under Section 804Notwithstanding
			 paragraph (1), the amendments made by paragraphs (1) and (3) of subsection (a)
			 and by subsection (b) shall take effect on the date that is 90 days after the
			 date of enactment of this Act with respect to qualifying drugs imported under
			 section 804 of the Federal Food, Drug, and
			 Cosmetic Act, as added by section 4.
				(3)Effect with
			 respect to registered exportersThe amendment made by subsection
			 (a)(2) shall take effect on the date that is 90 days after the date of
			 enactment of this Act.
				(4)Alternative
			 requirementsThe Secretary shall issue regulations to establish
			 the alternative requirements, referred to in the amendment made by subsection
			 (a)(1), that take effect not later than January 1, 2013.
				(5)Intermediate
			 requirementsThe Secretary shall by regulation require the use of
			 standardized anti-counterfeiting or track-and-trace technologies on
			 prescription drugs at the case and pallet level effective not later than 1 year
			 after the date of enactment of this Act.
				(6)Additional
			 requirements
					(A)In
			 generalNotwithstanding any other provision of this section, the
			 Secretary shall, not later than 18 months after the date of enactment of this
			 Act, require that the packaging of any prescription drug incorporates—
						(i)a
			 standardized numerical identifier unique to each package of such drug, applied
			 at the point of manufacturing and repackaging (in which case the numerical
			 identifier shall be linked to the numerical identifier applied at the point of
			 manufacturing); and
						(ii)(I)overt optically
			 variable counterfeit-resistant technologies that—
								(aa)are visible to the naked eye,
			 providing for visual identification of product authenticity without the need
			 for readers, microscopes, lighting devices, or scanners;
								(bb)are similar to that used by the
			 Bureau of Engraving and Printing to secure United States currency;
								(cc)are manufactured and distributed in a
			 highly secure, tightly controlled environment; and
								(dd)incorporate additional layers of
			 nonvisible convert security features up to and including forensic capability,
			 as described in subparagraph (B); or
								(II)technologies that have a function of
			 security comparable to that described in subclause (I), as determined by the
			 Secretary.
							(B)Standards for
			 packagingFor the purpose of making it more difficult to
			 counterfeit the packaging of drugs subject to this paragraph, the manufacturers
			 of such drugs shall incorporate the technologies described in subparagraph (A)
			 into at least 1 additional element of the physical packaging of the drugs,
			 including blister packs, shrink wrap, package labels, package seals, bottles,
			 and boxes.
					7.Internet sales
			 of prescription drugs
			(a)In
			 generalChapter V of the Federal
			 Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by
			 inserting after section 503B the following:

					503C.Internet
				sales of prescription drugs
						(a)Requirements
				regarding information on Internet site
							(1)In
				generalA person may not dispense a prescription drug pursuant to
				a sale of the drug by such person if—
								(A)the purchaser of
				the drug submitted the purchase order for the drug, or conducted any other part
				of the sales transaction for the drug, through an Internet site;
								(B)the person
				dispenses the drug to the purchaser by mailing or shipping the drug to the
				purchaser; and
								(C)such site, or any
				other Internet site used by such person for purposes of sales of a prescription
				drug, fails to meet each of the requirements specified in paragraph (2), other
				than a site or pages on a site that—
									(i)are not intended
				to be accessed by purchasers or prospective purchasers; or
									(ii)provide an
				Internet information location tool within the meaning of section 231(e)(5) of
				the Communications Act of 1934 (47
				U.S.C. 231(e)(5)).
									(2)RequirementsWith
				respect to an Internet site, the requirements referred to in subparagraph (C)
				of paragraph (1) for a person to whom such paragraph applies are as
				follows:
								(A)Each page of the
				site shall include either the following information or a link to a page that
				provides the following information:
									(i)The name of such
				person.
									(ii)Each State in
				which the person is authorized by law to dispense prescription drugs.
									(iii)The address and
				telephone number of each place of business of the person with respect to sales
				of prescription drugs through the Internet, other than a place of business that
				does not mail or ship prescription drugs to purchasers.
									(iv)The name of each
				individual who serves as a pharmacist for prescription drugs that are mailed or
				shipped pursuant to the site, and each State in which the individual is
				authorized by law to dispense prescription drugs.
									(v)If the person
				provides for medical consultations through the site for purposes of providing
				prescriptions, the name of each individual who provides such consultations;
				each State in which the individual is licensed or otherwise authorized by law
				to provide such consultations or practice medicine; and the type or types of
				health professions for which the individual holds such licenses or other
				authorizations.
									(B)A link to which
				paragraph (1) applies shall be displayed in a clear and prominent place and
				manner, and shall include in the caption for the link the words
				licensing and contact information.
								(b)Internet sales
				without appropriate medical relationships
							(1)In
				generalExcept as provided in paragraph (2), a person may not
				dispense a prescription drug, or sell such a drug, if—
								(A)for purposes of
				such dispensing or sale, the purchaser communicated with the person through the
				Internet;
								(B)the patient for
				whom the drug was dispensed or purchased did not, when such communications
				began, have a prescription for the drug that is valid in the United
				States;
								(C)pursuant to such
				communications, the person provided for the involvement of a practitioner, or
				an individual represented by the person as a practitioner, and the practitioner
				or such individual issued a prescription for the drug that was
				purchased;
								(D)the person knew,
				or had reason to know, that the practitioner or the individual referred to in
				subparagraph (C) did not, when issuing the prescription, have a qualifying
				medical relationship with the patient; and
								(E)the person
				received payment for the dispensing or sale of the drug.
								For
				purposes of subparagraph (E), payment is received if money or other valuable
				consideration is received.(2)ExceptionsParagraph
				(1) does not apply to—
								(A)the dispensing or
				selling of a prescription drug pursuant to telemedicine practices sponsored
				by—
									(i)a
				hospital that has in effect a provider agreement under title XVIII of the
				Social Security Act (relating to the
				Medicare program); or
									(ii)a group practice
				that has not fewer than 100 physicians who have in effect provider agreements
				under such title; or
									(B)the dispensing or
				selling of a prescription drug pursuant to practices that promote the public
				health, as determined by the Secretary by regulation.
								(3)Qualifying
				medical relationship
								(A)In
				generalWith respect to issuing a prescription for a drug for a
				patient, a practitioner has a qualifying medical relationship with the patient
				for purposes of this section if—
									(i)at least one
				in-person medical evaluation of the patient has been conducted by the
				practitioner; or
									(ii)the practitioner
				conducts a medical evaluation of the patient as a covering practitioner.
									(B)In-person
				medical evaluationA medical evaluation by a practitioner is an
				in-person medical evaluation for purposes of this section if the practitioner
				is in the physical presence of the patient as part of conducting the
				evaluation, without regard to whether portions of the evaluation are conducted
				by other health professionals.
								(C)Covering
				practitionerWith respect to a patient, a practitioner is a
				covering practitioner for purposes of this section if the practitioner conducts
				a medical evaluation of the patient at the request of a practitioner who has
				conducted at least one in-person medical evaluation of the patient and is
				temporarily unavailable to conduct the evaluation of the patient. A
				practitioner is a covering practitioner without regard to whether the
				practitioner has conducted any in-person medical evaluation of the patient
				involved.
								(4)Rules of
				construction
								(A)Individuals
				represented as practitionersA person who is not a practitioner
				(as defined in subsection (e)(1)) lacks legal capacity under this section to
				have a qualifying medical relationship with any patient.
								(B)Standard
				practice of pharmacyParagraph (1) may not be construed as
				prohibiting any conduct that is a standard practice in the practice of
				pharmacy.
								(C)Applicability
				of requirementsParagraph (3) may not be construed as having any
				applicability beyond this section, and does not affect any State law, or
				interpretation of State law, concerning the practice of medicine.
								(c)Actions by
				States
							(1)In
				generalWhenever an attorney general of any State has reason to
				believe that the interests of the residents of that State have been or are
				being threatened or adversely affected because any person has engaged or is
				engaging in a pattern or practice that violates section 301(l), the State may
				bring a civil action on behalf of its residents in an appropriate district
				court of the United States to enjoin such practice, to enforce compliance with
				such section (including a nationwide injunction), to obtain damages,
				restitution, or other compensation on behalf of residents of such State, to
				obtain reasonable attorneys fees and costs if the State prevails in the civil
				action, or to obtain such further and other relief as the court may deem
				appropriate.
							(2)NoticeThe
				State shall serve prior written notice of any civil action under paragraph (1)
				or (5)(B) upon the Secretary and provide the Secretary with a copy of its
				complaint, except that if it is not feasible for the State to provide such
				prior notice, the State shall serve such notice immediately upon instituting
				such action. Upon receiving a notice respecting a civil action, the Secretary
				shall have the right—
								(A)to intervene in
				such action;
								(B)upon so
				intervening, to be heard on all matters arising therein; and
								(C)to file petitions
				for appeal.
								(3)ConstructionFor
				purposes of bringing any civil action under paragraph (1), nothing in this
				chapter shall prevent an attorney general of a State from exercising the powers
				conferred on the attorney general by the laws of such State to conduct
				investigations or to administer oaths or affirmations or to compel the
				attendance of witnesses or the production of documentary and other
				evidence.
							(4)Venue; service
				of processAny civil action brought under paragraph (1) in a
				district court of the United States may be brought in the district in which the
				defendant is found, is an inhabitant, or transacts business or wherever venue
				is proper under section 1391 of title 28, United States Code. Process in such
				an action may be served in any district in which the defendant is an inhabitant
				or in which the defendant may be found.
							(5)Actions by
				other State officials
								(A)Nothing contained
				in this section shall prohibit an authorized State official from proceeding in
				State court on the basis of an alleged violation of any civil or criminal
				statute of such State.
								(B)In addition to
				actions brought by an attorney general of a State under paragraph (1), such an
				action may be brought by officers of such State who are authorized by the State
				to bring actions in such State on behalf of its residents.
								(d)Effect of
				SectionThis section shall not apply to a person that is a
				registered exporter under section 804.
						(e)General
				definitionsFor purposes of this section:
							(1)The term
				practitioner means a practitioner referred to in section 503(b)(1)
				with respect to issuing a written or oral prescription.
							(2)The term
				prescription drug means a drug that is described in section
				503(b)(1).
							(3)The term
				qualifying medical relationship, with respect to a practitioner
				and a patient, has the meaning indicated for such term in subsection
				(b).
							(f)Internet-Related
				definitions
							(1)In
				generalFor purposes of this section:
								(A)The term
				Internet means collectively the myriad of computer and
				telecommunications facilities, including equipment and operating software,
				which comprise the interconnected world-wide network of networks that employ
				the transmission control protocol/internet protocol, or any predecessor or
				successor protocols to such protocol, to communicate information of all kinds
				by wire or radio.
								(B)The term
				link, with respect to the Internet, means one or more letters,
				words, numbers, symbols, or graphic items that appear on a page of an Internet
				site for the purpose of serving, when activated, as a method for executing an
				electronic command—
									(i)to move from
				viewing one portion of a page on such site to another portion of the
				page;
									(ii)to move from
				viewing one page on such site to another page on such site; or
									(iii)to move from
				viewing a page on one Internet site to a page on another Internet site.
									(C)The term
				page, with respect to the Internet, means a document or other file
				accessed at an Internet site.
								(D)(i)The terms
				site and address, with respect to the Internet, mean
				a specific location on the Internet that is determined by Internet Protocol
				numbers. Such term includes the domain name, if any.
									(ii)The term domain name
				means a method of representing an Internet address without direct reference to
				the Internet Protocol numbers for the address, including methods that use
				designations such as .com, .edu,
				.gov, .net, or .org.
									(iii)The term Internet Protocol
				numbers includes any successor protocol for determining a specific
				location on the Internet.
									(2)Authority of
				SecretaryThe Secretary may by regulation modify any definition
				under paragraph (1) to take into account changes in technology.
							(g)Interactive
				computer service; advertisingNo provider of an interactive
				computer service, as defined in section 230(f)(2) of the
				Communications Act of 1934 (47 U.S.C.
				230(f)(2)), or of advertising services shall be liable under this section for
				dispensing or selling prescription drugs in violation of this section on
				account of another person’s selling or dispensing such drugs, provided that the
				provider of the interactive computer service or of advertising services does
				not own or exercise corporate control over such person.
						(h)No effect on
				other requirements; coordinationThe requirements of this section
				are in addition to, and do not supersede, any requirements under the Controlled
				Substances Act or the Controlled Substances Import and Export Act (or any
				regulation promulgated under either such Act) regarding Internet pharmacies and
				controlled substances. In promulgating regulations to carry out this section,
				the Secretary shall coordinate with the Attorney General to ensure that such
				regulations do not duplicate or conflict with the requirements described in the
				previous sentence, and that such regulations and requirements coordinate to the
				extent
				practicable.
						.
			(b)Inclusion as
			 prohibited ActSection 301 of the Federal Food, Drug, and Cosmetic Act (21
			 U.S.C. 331) is amended by inserting after paragraph (k) the following:

					(l)The dispensing or
				selling of a prescription drug in violation of section
				503C.
					.
			(c)Internet sales
			 of prescription drugs; consideration by Secretary of practices and procedures
			 for certification of legitimate businessesIn carrying out
			 section 503C of the Federal Food, Drug, and
			 Cosmetic Act (as added by subsection (a) of this section), the
			 Secretary of Health and Human Services shall take into consideration the
			 practices and procedures of public or private entities that certify that
			 businesses selling prescription drugs through Internet sites are legitimate
			 businesses, including practices and procedures regarding disclosure formats and
			 verification programs.
			(d)Reports
			 regarding Internet-Related violations of Federal and State laws on dispensing
			 of drugs
				(1)In
			 generalThe Secretary of Health and Human Services (referred to
			 in this subsection as the Secretary) shall, pursuant to the
			 submission of an application meeting the criteria of the Secretary, make an
			 award of a grant or contract to the National Clearinghouse on Internet
			 Prescribing (operated by the Federation of State Medical Boards) for the
			 purpose of—
					(A)identifying
			 Internet sites that appear to be in violation of Federal or State laws
			 concerning the dispensing of drugs;
					(B)reporting such
			 sites to State medical licensing boards and State pharmacy licensing boards,
			 and to the Attorney General and the Secretary, for further investigation;
			 and
					(C)submitting, for
			 each fiscal year for which the award under this subsection is made, a report to
			 the Secretary describing investigations undertaken with respect to violations
			 described in subparagraph (A).
					(2)Authorization
			 of appropriationsFor the purpose of carrying out paragraph (1),
			 there is authorized to be appropriated $100,000 for each of the first 3 fiscal
			 years in which this section is in effect.
				(e)Effective
			 dateThe amendments made by subsections (a) and (b) take effect
			 90 days after the date of enactment of this Act, without regard to whether a
			 final rule to implement such amendments has been promulgated by the Secretary
			 of Health and Human Services under section 701(a) of the
			 Federal Food, Drug, and Cosmetic
			 Act. The preceding sentence may not be construed as affecting the
			 authority of such Secretary to promulgate such a final rule.
			8.Prohibiting
			 payments to unregistered foreign pharmacies
			(a)In
			 generalSection 303 of the Federal Food, Drug, and Cosmetic Act
			 (21 U.S.C. 333) is amended by adding at the end the following:

					(h)Restricted
				transactions
						(1)In
				generalThe introduction of restricted transactions into a
				payment system or the completion of restricted transactions using a payment
				system is prohibited.
						(2)Payment
				system
							(A)In
				generalThe term payment system means a system
				used by a person described in subparagraph (B) to effect a credit transaction,
				electronic fund transfer, or money transmitting service that may be used in
				connection with, or to facilitate, a restricted transaction, and
				includes—
								(i)a
				credit card system;
								(ii)an
				international, national, regional, or local network used to effect a credit
				transaction, an electronic fund transfer, or a money transmitting service;
				and
								(iii)any other
				system that is centrally managed and is primarily engaged in the transmission
				and settlement of credit transactions, electronic fund transfers, or money
				transmitting services.
								(B)Persons
				describedA person referred to in subparagraph (A) is—
								(i)a
				creditor;
								(ii)a credit card
				issuer;
								(iii)a financial
				institution;
								(iv)an operator of a
				terminal at which an electronic fund transfer may be initiated;
								(v)a
				money transmitting business; or
								(vi)a participant in
				an international, national, regional, or local network used to effect a credit
				transaction, electronic fund transfer, or money transmitting service.
								(3)Restricted
				transactionThe term restricted transaction means
				a transaction or transmittal, on behalf of an individual who places an unlawful
				drug importation request to any person engaged in the operation of an
				unregistered foreign pharmacy, of—
							(A)credit, or the
				proceeds of credit, extended to or on behalf of the individual for the purpose
				of the unlawful drug importation request (including credit extended through the
				use of a credit card);
							(B)an electronic
				fund transfer or funds transmitted by or through a money transmitting business,
				or the proceeds of an electronic fund transfer or money transmitting service,
				from or on behalf of the individual for the purpose of the unlawful drug
				importation request;
							(C)a check, draft,
				or similar instrument which is drawn by or on behalf of the individual for the
				purpose of the unlawful drug importation request and is drawn on or payable at
				or through any financial institution; or
							(D)the proceeds of
				any other form of financial transaction (identified by the Board by regulation)
				that involves a financial institution as a payor or financial intermediary on
				behalf of or for the benefit of the individual for the purpose of the unlawful
				drug importation request.
							(4)Unlawful drug
				importation requestThe term unlawful drug importation
				request means the request, or transmittal of a request, made to an
				unregistered foreign pharmacy for a prescription drug by mail (including a
				private carrier), facsimile, phone, or electronic mail, or by a means that
				involves the use, in whole or in part, of the Internet.
						(5)Unregistered
				foreign pharmacyThe term unregistered foreign
				pharmacy means a person in a country other than the United States that
				is not a registered exporter under section 804.
						(6)Other
				definitions
							(A)Credit;
				creditor; credit cardThe terms credit,
				‘creditor’, and credit card have the meanings given the terms in
				section 103 of the Truth in Lending Act (15 U.S.C. 1602).
							(B)Access device;
				electronic fund transferThe terms access device
				and electronic fund transfer—
								(i)have the meaning
				given the term in section 903 of the Electronic Fund Transfer Act (15 U.S.C.
				1693a); and
								(ii)the term
				electronic fund transfer also includes any fund transfer covered
				under Article 4A of the Uniform Commercial Code, as in effect in any
				State.
								(C)Financial
				institutionThe term financial institution—
								(i)has the meaning
				given the term in section 903 of the Electronic Transfer Fund Act (15 U.S.C.
				1693a); and
								(ii)includes a
				financial institution (as defined in section 509 of the Gramm-Leach-Bliley Act
				(15 U.S.C. 6809)).
								(D)Money
				transmitting business; money transmitting serviceThe terms
				money transmitting business and money transmitting
				service have the meaning given the terms in section 5330(d) of title
				31, United States Code.
							(E)BoardThe
				term Board means the Board of Governors of the Federal Reserve
				System.
							(7)Policies and
				procedures required to prevent restricted transactions
							(A)RegulationsThe
				Board shall promulgate regulations requiring—
								(i)an operator of a
				credit card system;
								(ii)an operator of
				an international, national, regional, or local network used to effect a credit
				transaction, an electronic fund transfer, or a money transmitting
				service;
								(iii)an operator of
				any other payment system that is centrally managed and is primarily engaged in
				the transmission and settlement of credit transactions, electronic transfers or
				money transmitting services where at least one party to the transaction or
				transfer is an individual; and
								(iv)any other person
				described in paragraph (2)(B) and specified by the Board in such
				regulations,
								to
				establish policies and procedures that are reasonably designed to prevent the
				introduction of a restricted transaction into a payment system or the
				completion of a restricted transaction using a payment system.(B)Requirements
				for policies and proceduresIn promulgating regulations under
				subparagraph (A), the Board shall—
								(i)identify types of
				policies and procedures, including nonexclusive examples, that shall be
				considered to be reasonably designed to prevent the introduction of restricted
				transactions into a payment system or the completion of restricted transactions
				using a payment system; and
								(ii)to the extent
				practicable, permit any payment system, or person described in paragraph
				(2)(B), as applicable, to choose among alternative means of preventing the
				introduction or completion of restricted transactions.
								(C)No liability
				for blocking or refusing to honor restricted transaction
								(i)In
				generalA payment system, or a person described in paragraph
				(2)(B) that is subject to a regulation issued under this subsection, and any
				participant in such payment system that prevents or otherwise refuses to honor
				transactions in an effort to implement the policies and procedures required
				under this subsection or to otherwise comply with this subsection shall not be
				liable to any party for such action.
								(ii)ComplianceA
				person described in paragraph (2)(B) meets the requirements of this subsection
				if the person relies on and complies with the policies and procedures of a
				payment system of which the person is a member or in which the person is a
				participant, and such policies and procedures of the payment system comply with
				the requirements of the regulations promulgated under subparagraph (A).
								(D)Enforcement
								(i)In
				generalThis subsection, and the regulations promulgated under
				this subsection, shall be enforced exclusively by the Federal functional
				regulators and the Federal Trade Commission under applicable law in the manner
				provided in section 505(a) of the Gramm-Leach-Bliley Act (15 U.S.C.
				6805(a)).
								(ii)Factors to be
				consideredIn considering any enforcement action under this
				subsection against a payment system or person described in paragraph (2)(B),
				the Federal functional regulators and the Federal Trade Commission shall
				consider the following factors:
									(I)The extent to
				which the payment system or person knowingly permits restricted
				transactions.
									(II)The history of
				the payment system or person in connection with permitting restricted
				transactions.
									(III)The extent to
				which the payment system or person has established and is maintaining policies
				and procedures in compliance with regulations prescribed under this
				subsection.
									(8)Transactions
				permittedA payment system, or a person described in paragraph
				(2)(B) that is subject to a regulation issued under this subsection, is
				authorized to engage in transactions with foreign pharmacies in connection with
				investigating violations or potential violations of any rule or requirement
				adopted by the payment system or person in connection with complying with
				paragraph (7). A payment system, or such a person, and its agents and employees
				shall not be found to be in violation of, or liable under, any Federal, State
				or other law by virtue of engaging in any such transaction.
						(9)Relation to
				State lawsNo requirement, prohibition, or liability may be
				imposed on a payment system, or a person described in paragraph (2)(B) that is
				subject to a regulation issued under this subsection, under the laws of any
				state with respect to any payment transaction by an individual because the
				payment transaction involves a payment to a foreign pharmacy.
						(10)Timing of
				requirementsA payment system, or a person described in paragraph
				(2)(B) that is subject to a regulation issued under this subsection, must adopt
				policies and procedures reasonably designed to comply with any regulations
				required under paragraph (7) within 60 days after such regulations are issued
				in final form.
						(11)ComplianceA
				payment system, and any person described in paragraph (2)(B), shall not be
				deemed to be in violation of paragraph (1)—
							(A)(i)if an alleged violation
				of paragraph (1) occurs prior to the mandatory compliance date of the
				regulations issued under paragraph (7); and
								(ii)such entity has adopted or relied
				on policies and procedures that are reasonably designed to prevent the
				introduction of restricted transactions into a payment system or the completion
				of restricted transactions using a payment system; or
								(B)(i)if an alleged violation
				of paragraph (1) occurs after the mandatory compliance date of such
				regulations; and
								(ii)such entity is in compliance with
				such
				regulations.
								.
			(b)Effective
			 dateThe amendment made by this section shall take effect on the
			 day that is 90 days after the date of enactment of this Act.
			(c)ImplementationThe
			 Board of Governors of the Federal Reserve System shall promulgate regulations
			 as required by subsection (h)(7) of section 303 of the Federal Food, Drug, and
			 Cosmetic Act (21 U.S.C. 333), as added by subsection (a), not later than 90
			 days after the date of enactment of this Act.
			9.Importation exemption
			 under Controlled Substances Import and Export ActSection 1006(a)(2) of the Controlled
			 Substances Import and Export Act (21 U.S.C. 956(a)(2)) is amended by striking
			 not import the controlled substance into the United States in an amount
			 that exceeds 50 dosage units of the controlled substance. and inserting
			 import into the United States not more than 10 dosage units combined of
			 all such controlled substances..
		10.SeverabilityIf any provision of this Act, an amendment
			 by this Act, or the application of such provision or amendment to any person or
			 circumstance is held to be unconstitutional, the remainder of this Act, the
			 amendments made by this Act, and the application of the provisions of such to
			 any person or circumstance shall not affected thereby.