The author expresses her thanks to all those who assisted in this article.

1 U.S. CONST. art. VI, cl. 2.

2 21 U.S.C. § 301 (2005).

3 U.S. DEPT. OF HEALTH & HUMAN SERVICES, REPORT ON PRESCRIPTION DRUG IMPORTATION 4 (2004), http://www.hhs.gov/importtaskforce/Report1220.pdf.

4 Id. at 10.

5 See id. at 25 (noting “most of the prescription drugs imported into the U.S. now by individual citizens, via mail and courier service, fail to comply with some or all” of the FDCA).

6 See generally Section III, infra at 9-20 (reviewing new state initiatives to facilitate personal importation of prescription drugs from Canada).

7 See Subcomm. on Oversight and Investigations of the H. Comm. on Energy and Commerce (2003) (statement of William Hubbard, FDA Associate Commissioner for Policy, Planning and Legislation), available at http://www.fda.gov/ola/2003/importedrx0624.html (testifying that state BOPs “have primary responsibility for licensing of pharmacies and regulating the dispensing of drugs.”). See also 21 U.S.C. § 353(b)(1) (2004) (describing how prescription drugs will be dispensed by licensed pharmacy).

8 See National Association of Boards of Pharmacy Newsletter, April 2005, Vol. 34, No. 4 at 72 (quoting the primary sponsor of the Rhode Island bill to license Canadian pharmacies who said the bill was introduced because “some have to make the choice between buying food or medications … the pharmaceuticals are exorbitantly priced.” (internal quotes omitted)).

9 See 21 U.S.C. § 381(d)(1) (2005).

10 See 21 U.S.C. § 355 (2003); See also 21 C.F.R. § 314.50 (2005) ( FDA approvals are manufacturer and product specific, with many requirements).

11 See 21 U.S.C. §§ 352(a), 353(b)(2) (2005). See also In re: Canadian Import Antitrust Litigation, Civ. No. 04-2724 (D. Minn. 2005) (adopting magistrate's conclusion that “prescription drugs from Canada for personal use in the United States are misbranded.”).

12 See 21 U.S.C. § 353(b)(1) (2004).

13 Hearing Before the S. Special Comm. on Aging (statement of William K. Hubbard, Senior Associate Commissioner for Policy, Planning and Legislation, FDA) (2002). See also Letter from David Horowitz, Director, Office of Compliance, CDER, FDA to Harry Lee Jones, Store Manager, Rx. Depot (Mar. 21, 2003), available at http://www.fda.gov/foi/warning_letters/g3888d.htm.

14 See Marilyn Chase, Buying the Wrong Medicine Overseas, THE WALL STREET JOURNAL, August 16, 2005, at D1 (reporting that drugs from foreign countries may have the same brand name as an American drug, but may be for a different condition and have a different ingredient composition, posing a danger to patient safety); HHS Task Force Report at 14 (noting that a foreign FDA-approved plant that manufactures an FDA-approved drug may manufacture lines similar to that drug, but that does not make them all FDA-approved).

15 See 21 C.F.R. § 314.50 (2005) (listing several requirements related to approval including manufacturing location, packaging location and appearance).

16 Letter from William Hubbard, Associate Commissioner for Policy and Planning, to Gregory Gonot, Deputy Attorney General, California (Aug. 25, 2003) (discussing the misrepresentations about FDA's policy on personal importation) available at http://www.fda.gov/opacom/gonot.html.

17 See 21 U.S.C. § 352 (2004).

18 See 21 U.S.C. § 352 (c) (2004).

19 See 21 U.S.C. § 352 (o) (2004).

20 See U.S.C. § 352 (c) (2004) (requiring labeling to be readily readable by consumer).

21 United States v. 1500 90-Tablet Bottles, 384 F. Supp. 2d 1205 (N.D. Ill. 2005).

22 Id. at 1206-1207 (seeking also to enjoin defendants from future shipments).

23 Id. at 1207.

24 Id. at 1209.

25 Id. at 1207-1208.

26 Id. at 1207.

27 Id.

28 Id. at 1210, 1212.

29 Id. at 1211.

30 Id. at 1210-1211.

31 Id. at 1207.

32 Id. at 1210-1211.

33 Id. at 1214.

34 Id. at 1212.

35 Id. at 1210-1211.

36 Id. at 1213.

37 Id. at 1211.

38 Id. at 1215 (noting that it isn't enough that the drugs for foreign distribution have the same chemical composition as their American counterparts, rather “[t]o be introduced into interstate commerce under the cover of an FDA-approved [drug application] …, the drugs must comply with all requirements …” of the drug application) (emphasis added).

39 See generally Clifford Kraus, Canada Drafting Regulations to Curb Bulk Drug Exports to U.S., N.Y. TIMES, June 30, 2005, at A1 (quoting the Canadian Minister of Health saying that the Canadian government “has to make sure that we protect the safety and supply of the drugs for Canadians.”).

40 See Hubbard Letter, supra note 16.

41 But see 21 C.F.R. § 1301.26 (2005) (allowing persons coming from Mexico or Canada to cross into the U.S. with no more than 50 doses of a controlled substance for their personal medical use pursuant to the Controlled Substances Act).

42 It is beyond the scope of this article, but in some instances, those internet sites that claim to be Canadian pharmacies, or pharmacies operating in other countries, may not be what they claim. See Importation of Prescription Drugs in the U.S. and the Use of the Internet: Hearing Before the Comm. On the Judiciary, 108th Cong. 11 (2004) (statement of William K. Hubbard, Associate Commissioner for Policy and Planning, U.S. Food and Drug Admin. (illustrating the dangers to consumers who rely on websites that purport to be Canadian pharmacies), available at http://www.fda.gov/ola/2004/importeddrugs0714.html.

43 See Hubbard Letter, supra note 16, at 3-4.

44 FDA, Regulatory Procedures Manual, ch. 9, subch. Coverage of Personal Importations, available at http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9pers.html (last visited Jan. 31, 2006).

45 See Hubbard Letter, supra note 16.

46 Id. at 4.

47 Regulatory Procedures Manual, supra note 44, at 2.

48 FDA, Information on Importation of Drugs, available at http://www.fda.gov/ora/import/pipinfo.htm (last visited Jan. 31, 2006).

49 See Regulatory Procedures Manual, supra note 44, at 1 (noting that FDA is focusing its resources on illegal commercial importations).

50 See id. at 3.

51 See id.

52 See Canadarx, http://www.canadarx.com (“Most drugs available to Americans are also available in Canada and other countries around the world, often for considerably less money.”).

53 See Regulatory Procedures Manual, supra note 44

54 Id.

55 See U.S. v. Rx Depot, 290 F. Supp. 2d 1238, 1247, 1250 (N.D. Okla. 2003) (issuing injunction against local operation that facilitated importation of prescription drugs from Canada because federal government showed conclusively “that the relevant statutory provision explicitly prohibit what defendants continue to do.”).

56 Hyman, Paul M., Legal Overview of FDA Authority Over Imports, 49 FOOD & DRUG L.J. 525, 532 (1994)Google Scholar.

57 Rx Depot, 290 F. Supp. 2d at 1246 (internal citation omitted).

58 U.S. v. Dotterweich, 320 U.S. 277, 280 (1943). U.S. DEPT. OF HEALTH & HUMAN SERVICES, supra note 3, at vii (pointing out Congress’ purpose of creating “a strong oversight body” to ensure safety of drugs under FDCA).

59 U.S. DEPT. OF HEALTH & HUMAN SERVICES, supra note 3, at 4.

60 FDA Mission Statement, http://www.fda.gov/opacom/morechoices/mission.html.

61 U.S. DEPT. OF HEALTH & HUMAN SERVICES, supra note 3, at vii-viii.

62 Rx Depot, 290 F. Supp. 2d at 1248 (internal citations omitted).

63 See Press Release, FDA, Recent FDA/U.S. Customs Import Blitz Exams Continue to Reveal Potentially Dangerous Illegally Imported Drug Shipments,” (Jan. 27, 2004) http://www.fda.gov/bbs/topics/NEWS/2004/NEW01011.html.

64 See id. (describing the mislabeling to include “strictly foreign labeling, many contained duel labeling (in both English and a foreign language) and several contained no labeling whatsoever and were simply loose in plastic baggies or wrapped in tissue paper.”).

65 See FDA, Importing Prescription Drugs, http://www.fda.gov/importeddrugs (stating that a “growing number of Americans obtain their medications from foreign locations, often seeking out suppliers in Canada. But FDA cannot ensure the safety of drugs bought from these sources.”).

66 Krulwich, Andrew S., & Dame, Paul A., Drug Importation: From the ‘Quick Fix’ to ‘Quagmire’ Via Public Policy, Economics and the Law,” BRIEFLY … PERSPECTIVES ON LEGISLATION, REGULATION & LITIGATION, (National Legal Center for the Public Interest, Washington, D.C.), Vol. 9, No. 3, March 2003, at 16 (on file with author)Google Scholar.

67 Id. at 14.

68 See, e.g., ALA. CODE § 34-23-92 (2002) (listing all the duties imparted to the BOP); CAL. BUS.& PROF. CODE §§ 4005-008 (2004); TENN. CODE ANN. § 63-10-304 (2004).

69 See, e.g., ALA. CODE § 34-23-92(11) (2002); CAL. BUS.& PROF. CODE §§ 4001(a), 4008; TENN. CODE ANN. § 63-10-304 (2004).

70 See U.S. DEPT. OF HEALTH & HUMAN SERVICES, supra note 3, at 31.

71 Nat. Ass’n of Bds of Pharmacy, Position Paper on the Importation of Foreign Prescription Drugs, Mar. 2003, at 6 (on file with author), available at http://www.nabp.net/ftpfiles/NABP01/foreigndrug.pdf, (noting that, at the time, 43 out of 50 boards required non-resident pharmacies to get licensed to send drugs to patients in their respective states (citing Nat. Ass’n of Bds of Pharmacy, Survey of Pharmacy Law, 45-47 (2002-2003)) [hereinafter NABP Position Paper].

72 See ALA. CODE § 34-23-31.

73 See, e.g., CAL BUS. & PROF. § 4112 (d) (“nonresident pharmacy shall maintain, at all times, a valid unexpired license, permit, or registration to conduct the pharmacy in compliance with the laws of the state in which it is a resident.); IOWA CODE ANN. § 155A.13A (2005) (“Submit evidence of possession of a valid license, permit, or registration as a pharmacy in compliance with the laws of the state in which it is located,”); S.D. CODIFIED LAWS § 36-11-19.3 (1999) (“[b]e licensed and in good standing in the state in which its dispensing facilities are located”).

74 See Canadian Drug Imports to the United States, NAT. ASS’N OF BDS. OF PHARMACY NEWSLETTER (Nat. Ass’n of Bds. of Pharmacy, Mount Prospect, IL), Vol. 31, No. 8, Sept. 2002, at 108 (disclosing aggregate results of survey of BOPs regarding whether their state pharmacy practice acts allowed them to license Canadian pharmacies, and revealing that more than 70% said “no”) [hereinafter NABP Survey Report].

75 See id. (indicating that out of the 24% of BOPs that thought they could license Canadian pharmacies, only one third, or three states, said they were planning on it).

76 NABP Position Paper, supra note 71, at 6.

77 See id.

78 See generally Sections III.A-F., infra pp. 9-20 (reviewing state efforts to legitimize Canadian pharmacies).

79 See, e.g., MINN. DEP't OF HUMAN SERVS, HEALTH CARE ADMIN., REQUEST FOR RESPONSES CANADIAN PHARMACIES, at 10 [hereinafter REQUEST FOR RESPONSES] (on file with author)..

80 See MINN STAT. § 151.19, Subdiv. 2.

81 See generally MINN. STAT. §§ 151.01-.03.

82 See Goodno, Kevin & Janisch, Karen, Minnesota: Leading the Way on Canadian Prescription Medicine Importation, 31 WM. MITCHELL L. REV. 811, 813-14, 817 (2005)Google Scholar (concluding that federal law does not prohibit the state from sharing information about or promoting importation, therefore, it does not prohibit Minnesota's program).

83 Id. at 814.

84 Id. at 814.

85 Id.

86 Id. At the time of the writing of this article, the author has no information that this third option is being actively pursued by either the state or Minnesota retail pharmacies.

87 Id. See also Minnesota RxConnect, http://www.state.mn.us/portal/mn/jsp/home.do?agency=Rx (last visited Feb. 5, 2006).

88 See Goodno & Janish, supra note 82, at 817 (claiming that the state is merely providing consumers information).

89 See REQUEST FOR RESPONSES, supra note 79.

90 Id. at 2.

91 Id.

92 Id. at 3.

93 Id.

94 Id. at 3-6.

95 Id. at 5.

96 Id. at 7 (failing to mention if the BOP would review these applications).

97 Memorandum from Cody Wiberg, Manager, Pharmacy Program, to Kevin Goodno, Commissioner, Dep't of Human Servs., Report on the Survey of Canadian Pharmacies, at 1 (undated) (unpublished manuscript, on file with author) [hereinafter Wiberg Memo].

98 Id.

99 Id.

100 See David Hanners, Drug Reimportation: Grading System May be Used, PIONEER PRESS, March 3, 2004, at B1 (on file with author).

101 See Wiberg Memo, supra note 97, at 1.

102 Id. See also Memorandum from Michelle Mattila and Stuart Vandenberg, Surveyors, Pharmacy Board, to David Holstrom and the Minnesota BOP Members, at 1 (December 24, 2003) (on file with author) [hereinafter Surveyor's Memo].

103 Surveyor's Memo, supra note 102, at 1. This caveat implies that the BOP surveyors were not able to operate under the normal comprehensive BOP standards in assessing the Canadian pharmacies and may not have been comfortable with that limitation.

104 Id. at 5.

105 Id. at 6.

106 Id.

107 Id. at 1.

108 Id. at 2-5.

109 Id. at 6 (rejecting four others as unacceptable).

110 State of Minnesota Department of Human Services Agreement, DHS-Total Care Pharmacy, Jan. 15, 2004, at 1; State of Minnesota Department of Human Services Agreement, DHS-Granville Pharmacy Ltd., Jan. 15, 2004, at 1 [hereinafter jointly “MN Canadian Pharmacy Contracts] (on file with author).

111 Id.

112 Id. Notably, the state of Minnesota does not delude itself that the Canadian pharmacies with whom it has contracted will provide its citizens FDA-approved drugs, but it still claims that this undertaking does not violate federal law. See, Goodno & Janisch, supra note 82 (discussing legality assertions made by state).

113 MN Canadian Pharmacy Contracts, supra note 110, at 1.

114 Letter from Kevin Goodno, Commissioner, DHS, to Tom Pawlenty, Governor, State of Minn., at 1 (Mar. 18, 2005) [hereinafter Goodno Letter] (on file with author), available at http://www.state.mn.us/mn/externalDocs/Rx/Importation_of_Prescription_Drugs_from_Europe_A_Report_to_Commissi_051305114048_03-05%20Importation%20Report.pdf.

115 Id. at 1-2.

116 Id. at 2.

117 Brian Osberg & Cody Wiberg IMPORTATION OF PRESCRIPTION DRUGS FROM EUROPE: A REPORT TO COMMISSIONER KEVIN GOODNO, at 1-2 (2005)(on file with author), available at http://www.state.mn.us/mn/externalDocs/Rx/Importation_of_Prescription_Drugs_from_Europe_A_Report_to_Commissi_051305114048_03-05%20Importation%20Report.pdf. Notably, it does not appear that pharmacy surveyors conducted on-site inspections of the pharmacies in the U.K. See id. at 9 (mentioning only the DHS employees).

118 Goodno & Janisch, supra note 82, at 817.

119 See Minnesota RxConnect: Legal information, http://www.state.mn.us/portal/mn/jsp/content.do?programid=536902438&agency=Rx (last visited September 9, 2005).

120 Id.

121 In 2004, the State of Illinois, jointly with the State of Wisconsin, launched a similar webbased program called I-SaveRx. Under this program, the State of Illinois contracted with a Canadian pharmacy clearing-house that has a network of forty-five wholesalers and pharmacies in Canada, Ireland and the United Kingdom to ship drugs to the citizens of Illinois and Wisconsin. See Courtney Flynn, State starts drug import plan, CHICAGO TRIBUNE, October 5, 2004, at 1, available at http://www.chicagotribune.com/features/health/chi-o410050252octo5,1,4173495.story?coll=chi-newshed. Supposedly, the foreign wholesalers and pharmacies are subject to “ongoing inspections by Illinois officials,” but it is not clear that those officials are from the BOP or have any regulatory authority over these entities. Id. (noting state officials claim that these foreign entities are subject to “standards”). Missouri, Kansas, and Vermont have joined I-SaveRx. Press Release, Office of the Governor, Governor Blagojevich and partners in I-SaveRx drug importation program announce major supply expansion (July 18, 2005) (on file with author), available at http://www.illinois.gov/PressReleases/ShowPressRelease.cfm?SubjectID=3&RecNum=4164 (discussing more broadly how I-SaveRx is expanded to import drugs from Australia and New Zealand).

122 2005 Me. Laws 165.

123 See id.

124 See id.

125 See id. (noting further that the “program must operate within the limits of federal law and regulation and state law and rule.”). The waiver referred to is one that the states are under the misimpression they can receive from the U.S. Department of Health and Human Services to allow them to operate an importation program without somehow violating federal law. In fact, the Secretary's waiver authority only allows him to “grant to individuals, by regulation or on a case-bycase basis, a waiver of the prohibition of importation of prescription drug …” and only after he/she has certified to Congress that importation does not pose a significant safety risk. 21 U.S.C. § 384(j) (2005). Congress has not given the Secretary any authority to issue waivers for state-run personal importation programs. See id.

126 Compare H.B. 369, 122nd Leg., 1st Reg. Sess. § 3(A) (Me. 2005) (referring to an in-state pharmacist as coordinating prescriptions), with id. at Sec. 3.C. (allowing the state to “approve” foreign pharmacies to dispense prescription drugs to Maine residents under the program).

127 See id. § 3(C).

128 H.B. 406, 122nd Leg., 1st Reg. Sess. § 1 (Me. 2005).

129 Id. § 2(B) (failing to clarify whether this is limited to foreign pharmacies and wholesalers).

130 Id. § 2(C).

131 Id. § 2(D).

132 See S.B. 5, 2005 Leg., 22nd Spec. Sess. (Nev. 2005).

133 Cf. NEV. REV. STAT. § 639.230 et. seq. (2004) .

134 See id. § 639.2328 (2)(a).

135 S.B. 5, 2005 Leg., 22nd Spec. Sess. § 2 (Nev. 2005) (revising NEV. REV. STAT. § 639.2328 (2)(a)(2003)). See also id. § 3 (revising NEV. REV. STAT § 639.23284 (2003) to allow pharmacies to provide drugs via mail if inspected by regulatory authority in state or country of residence).

136 Id § 2 (reciting the language of NEV. REV. STAT. § 639.2328(2)(b)(2003)).

137 Id. § 1 (6) (adding language to NEV. REV. STAT. § 639.230 (2004)).

138 See id. § 3 (adding such restrictions at NEV. REV. STAT. § 639.23284(2)(2003)).

139 Id. § 3 (adding such restrictions at NEV. REV. STAT. § 639.23284(2)(b)(2003)).

140 Id. § 6 (adding new NEV. REV. STAT. § 223.560(9)(2005)).

141 Id.

142 Letter from Randall W. Lutter, Ph.D., Assoc. Comm’r for Policy and Planning, to Kenny Guinn, Governor of Nev. (May 20, 2005) available at http://www.fda.gov/oc/opacom/hottopics/importdrugs/guinn052005.html.

143 Id. at 1.

144 Id.

145 Id.

146 Nevada State Board of Pharmacy, Canadian Pharmacy Application Information and Checklist Internet Services (on file with author).

147 See id. (asking for contact information, license information, ownership information, and criminal/disciplinary record).

148 Id. at 4.

149 Id. at 4-5.

150 Id. at 5.

151 Brendan Riley, Seven Canadian Pharmacies Endorsed for Nevada Licenses, LAS VEGAS SUN, September 7, 2005 (noting that the approvals should be final by the end of September 2005).

152 On the date of submission of this article, Nevada announced that it would not move forward with its plan to license Canadian pharmacies until the attorney general issues an opinion on what it means to be an FDA-approved drug. Cy Ryan, Plan for Imported Prescription Drugs Put on Hold, LAS VEGAS SUN, Sept. 29, 2005, available at http://www.lasvegassun.com/sunbin/stories/sun/2005/sep/29/519436669.html. On December 27, 2005, the Nevada Attorney General issued his opinion, concluding that an FDA-approved drug permissibly imported under Senate Bill No. 5 is one that is actually approved by the FDA for the American consumer. See Letter from George Chanos, Attorney Gen. of Nev., to Larry L. Pinson, Pharm.D., Executive Sec’y, Nev. State Bd of Pharmacy (December 27, 2005), available at http://ag.state.nv.us/agopinions/2005/sb5.pdf.

The practical impact of this decision is that Canadian pharmacies could not import prescription drugs to Nevadans because Canadian pharmacies do not sell such FDA-approved drugs. That was not an acceptable result to the Nevada State Board of Pharmacy – disregarding the attorney general's opinion, it voted in January 2006 to proceed with the importation program. Brendan Riley, Nevada's Canadian Drug Import Plan Moves Ahead, LAS VEGAS SUN, January 12, 2006, available at http://www.lasvegassun.com/sunbin/stories/nevada/2006/jan/12/011210226.html. Nevada's website listing licensed Canadian pharmacies became active in May 2006. See http://govcha.state.nv.us/CPindex.htm.

153 H. 7320, 2004 Leg., Gen.Assem., (R.I. 2004) (adding R.I. Gen. Laws § 5.19.1-11(b)).

154 Id.

155 H. 7320, 2004 Leg., Gen.Assem., (R.I. 2004) (adding R.I. Gen. Laws § 5.19.1-11 Rules).

156 See Felice J. Freyer, Canadian Drugs a Headache for Regulators, THE PROVIDENCE JOURNAL (Rhode Island), Sept. 16, 2004, at B-01. See also Rhode Island Moves Forward in Licensing Canadian Pharmacies, NATIONAL ASSOC. OF BOARDS OF PHARMACY NEWSLETTER (National Assoc. of Boards of Pharmacy, Mt. Prospect, IL), April, 2005 at 73Google Scholar (describing comments of BOP director).

157 Letter from William K. Hubbard, Associate Commissioner for Policy and Planning, FDA to Donald Carcieri, Governor, State of Rhode Island, (July 1, 2004), (http://www.fda.gov/oc/opacom/hottopics/importdrugs/carcieri.pdf) (raising several legal and safety concerns).

158 “AG Warns Law on Canadian Imports Could Violate Federal Laws, Regulations,” BNA Pharmaceutical Law & Industry, August 20, 2004, Vol. 2, No. 24, at 942Google Scholar (noting also the warning by the state attorney general that state law may violate federal law).

159 Freyer, supra note 156, at B6.

160 “Recommended Implementing Amendments” for Non-resident pharmacies, Rules and Regulations Pertaining to Pharmacist, Pharmacies, and Manufacturers, Wholesalers and Distributors, State of Rhode Island and Providence Plantations, Department of Health, Board of Pharmacy, October 25, 2004 (in author's file).

161 See Letter from R. Daniel Prentiss, Esquire, Holland & Knight, LLP (on behalf of Pharmaceutical Research and Manufacturers of America, PhRMA) to Susan DelMonico, Esq., R.Ph., Chair, Rhode Island BOP, (October 19, 2004) (challenging the validity of the proposed regulations and underlying law) (in author's file).

162 Felice J. Freyer, State Pharmacy Board Rejects Rules for Canadian Drug Imports, THE PROVIDENCE JOURNAL (Rhode Island), Oct. 21, 2004, at A-01, available at http://www.projo.com/news/content/projo_20042021.25a7fe.html (noting the BOPs unanimous vote against the proposed regulations).

163 Id.

164 See Rhode Island Board of Pharmacy, Instructions and Application for Pharmacy Non- Resident License (Canada), January 20, 2005 available at http://www.health.ri.gov/hsr/professions/apps/PharmacyNonResCanada.pdf (listing the requirements to include a $125 fee, a valid provincial license, compliance with Rhode Island regulations for mailorder pharmacies, and a completed application) (in author's file).

165 See Canadian Pharmacy Applications now Online, PROVIDENCE BUSINESS NEWS, PBN.COM, Jan. 20, 2005, Issue 19-40, available at [Rule 18.2.2] http://www.pbn.com/stories/printdetails.php?id=112333. See also, Felice J. Fryer, R.I Edges Closer to Allowing Sales of Canadian Drugs, THE PROVIDENCE JOURNAL (Rhode Island), June 13, 2005, at A-01 (reporting that four Canadian pharmacies applied for licensure but their applications were delayed by the evolving regulations).

166 Memorandum from Charles Alexandre, MS, RN, Chief, Office of Health Professional Regulation to Members of the Community Interested in the: Rules and Regulations Pertaining to Pharmacists, Pharmacies, and Manufacturers, Wholesalers and Distributors (R5-19.1-PHAR) (March 23, 2005), (with attached proposed rule amendment) (in author's file).

167 Id.

168 Id. at 49 (adding a new Section 18.9, Canadian Pharmacies, to the regulations).

169 Rules and Regulations Pertaining to Pharmacists, Pharmacies, and Manufacturers, Wholesalers and Distributors, State of Rhode Island and Providence Plantations, Dep't of Health, Board of Pharmacy, March 1985, as amended May 2005 (Proposed) (in author's file).

170 See RI Pharmacy Reg. R5-19.1-PHAR – Sec. 18.0 et seq., as amended.

171 RHODE ISLAND BOARD OF PHARMACY, INSTRUCTIONS AND APPLICATION FOR PHARMACY NON-RESIDENT LICENSE (Canada), January 20, 2005, revised July 14, 2005 (July Final Regulations), available at http://www.health.ri.gov/hsr/professions/apps/PharmacyNonResCanada.pdf (in author's file).

172 S. 410, 79th Leg., Legis. Sess. (Tex. 2005), available at http://www.capitol.state.tx.us/cgibin/tlo/textframe.cmd?LEG=79&SESS=R&CHAMBER=S&BILLTYPE=B&BILLSUFFIX=00410&VERSION=5&TYPE=B.

173 Id. at Sec. 37 (adding Sec. 554.016 to Subchapter A, Chapter 554, Occupations Code).

174 Id. (adding Sec. 554.016(a)).

175 Id. (adding Sec. 554.016(c)).

176 Id.

177 Id. at Sec. 38 (adding Sec. 556.055(a-b) to Subchapter B, Chapter 556, Occupations Code) (noting that BOP has the authority to create standards and process for inspections).

178 Id. (adding Sec. 556.055(c) to Subchapter B, Chapter 556, Occupations Code).

179 Id. at Sec. 39 (amending Sec. 560.001(c), Occupations Code).

180 Id. at Sec. 40 (adding Sec. 560.0525(a), Occupations Code).

181 Id. at Sec. 40 (adding Sec. 560.0525(b), Occupations Code).

182 Id. at Secs. 41-44.

183 Id. at Sec. 42 (adding Sec. 562.111, Subchapter C, Occupations Code).

184 Letter from Randall W. Lutter, Ph.D., Acting Assoc. Comm’r for Policy and Planning, Food and Drug Admin., to Rick Perry, Governor of Tex. (June 17, 2005), available at http://www.fda.gov/oc/opacom/hottopics/importdrugs/perry061705.html.

185 See id. at 1-2.

186 Clay Robison, Canada Drug Provision on Hold: A Law Designed to Help Texans Buy Imports Hits a Snag as Lawyers Address a Federal Complaint, HOUSTON CHRON., Aug. 31, 2005, at B4, available at http://www.chron.com/CDA/archives/archive.mpl?id=2005_3899431.

187 See id.

188 See id.

189 On December 21, 2005, after this article was submitted, the Texas Attorney General issued his opinion on whether federal law preempts Texas law to authorize Canadian pharmacies to import prescription drugs. See Letter from Greg Abbott, Att’y Gen. of Tex., to Gay Dodson, R.Ph., Executive Dir./Sec’y, Tex. State Bd. of Pharmacy (Dec. 21, 2005), available at http://www.oag.state.tx.us/opinions/op50abbott/ga-0384.htm. The Attorney General concluded that state law directly conflicted with and was preempted by federal law restricting importation of prescription drugs. See id. He also concluded that “[b]y ‘designating certain Canadian pharmacies, promoting them on its website, and expressly permitting Texas consumers to import prescription drugs that cannot be imported under federal law, the Texas State Board of Pharmacy would violate the [Federal Food Drug and Cosmetic Act] …” Id. As of May 2006, how the Board of Pharmacy or the State Legislature intended to proceed in light of this opinion was unknown.

190 H.R. 1168, 59th Leg., Reg. Sess. (Wash. 2005), available at http://www.leg.wa.gov (search for “1168” under “Bill Search”; then follow “Bill as Passed Legislature” hyperlink under “Available Documents”) (amending RCW 18.64.350 and 18.64.360, and adding a new section to Ch. 18.64 RCW).

191 See id. at Sec. 4 (adding new section to chapter 18.64RCW) (instructing the BOP to submit a waiver request to FDA and, subsequent to approval, directing the BOP to license Canadian pharmacy in accordance with the newly revised non-resident pharmacy law).

192 Id. at Sec. 3 (amending RCW 18.64.360(1)).

193 Id. at Sec. 3 (amending RCW 18.64.360(9)).

194 Id.

195 See S. 5470, 59th Leg., Reg. Sess. (Wash. 2005) available at http://www.leg.wa.gov (search for “5470” under “Bill Search”; then follow “Bill as Passed Legislature” hyperlink under “Available Documents”) (adding a section to Ch. 18.64 RCW).

196 See id. Sec. 2 (adding a section to Ch. 18.64 RCW).

197 See id.

198 See id.

199 See id.

200 See 21 U.S.C. § 384(j), supra note 125 (discussing how waiver does not apply to states).

201 U.S. CONST. art. VI, cl. 2.

202 See id. (noting the supremacy of federal law “notwithstanding” anything to the contrary in state law).

203 See, e.g., 21 U.S.C. § 379r(a)(2) (2000) (ensuring national uniformity of nonprescription drugs, Congress expressly prohibits states from imposing any requirement that “is different from or in addition to, or that is otherwise not identical with” the requirements under certain federal labeling laws). See Mich. Canners and Freezers Ass’n v. Agricultural Marketing and Bargaining Board, 467 U.S. 461, 469 (1984) (internal citation omitted).

204 Jones v. Rath Packing Co., 430 U.S. 519 (1977).

205 See id. at 525.

206 Id. at 530 n.17.

207 See id. at 530-32.

208 See Sprietsma v. Mercury Marine, 537 U.S. 51, 64-65 (2002) (internal citations omitted); Hines v. Davidowitz, 312 U.S. 52, 67 (1941) (referring to Congressional statute as “occupying the field”).

209 See Sprietsma, 537 U.S. at 64.

210 Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947) (internal citations omitted).

211 Hines, 312 U.S. at 66-67.

212 Id. at 74.

213 See id. at 56, 74.

214 Mich. Canners and Freezers Ass’n, 467 U.S. at 469.

215 Hines, 312 U.S. at 67 & n.20 (pointing out that “[i]f the purpose of the act cannot otherwise be accomplished – if its operation within its chosen field else [sic] must be frustrated and its provisions be refused their natural effect – the state law must yield to the regulation of Congress within the sphere of its delegated power”). See also Neill v. State Farm Fire. & Cas. Co., 159 F. Supp. 2d 770, 778 (E.D. Pa. 2000) (discussing how field preemption and conflict preemption “are not very distinct” such that analysis may overlap).

216 Mich. Canners and Freezers Ass’n, 467 U.S. 461 (1984).

217 Id. at 469-70 (internal citations omitted).

218 See id. at 496.

219 Id. at 470.

220 See id.

221 See id. at 470-71 (noting the “theme of voluntariness is carried through to the provisions of the Act … “).

222 Id. at 471 (pointing out that “producer's free choice” was of particular congressional concern).

223 Id. at 477-78.

224 See id. at 478.

225 See Capital Cities Cable, Inc. v. Crisp, 467 U.S. 691, 708 (1984).

226 See id. at 696 (making other constitutional arguments including violation of First Amendment free speech and the Commerce Clause).

227 Id. at 697.

228 Id. at 698 & n.5 (citing to the Twenty-first Amendment's provision granting states broad power to regulate transportation and importation of intoxicating liquors).

229 Id. at 708 (citing 47 U.S.C. § 151 (2000)).

230 Id.

231 See id. at 716.

232 Gade v. Nat’l Solid Wastes Mgmt. Ass’n, 505 U.S. 88 (1992).

233 Id. at 91-93.

234 See id. at 92-93 (citing 29 C.F.R. § 1910.120 (1991)).

235 Id. at 93.

236 Id.

237 Id. at 96.

238 Id.

239 See id. at 103- 04.

240 Id. at 105-06.

241 Id. at 103 (internal quoting Int’l Paper Co. v. Ouellette, 479 U.S. 481, 494 (1987) citations omitted).

242 See id. at 103, 107 (noting that a law that regulates occupational safety and health may be preempted by federal OSHA law even if it also has a nonoccupational goal).

243 Id. at 107.

244 Id. at 108 (quoting Goldfarb v. Va. State Bar, 421 U.S. 733, 792 (1975)).

245 Id. (quoting Felder v. Casey, 487 U.S. 131, 138 (1988)).

246 Id. at 108.

247 See, e.g., 21 U.S.C. §§ 352, 353, 381(d)(1). See also discussion, supra pp. 221-22 (reviewing relevant FDCA provisions).

248 See discussion, supra pp. 224-25 (discussing policy reasons for FDCA).

249 See Letter from Lutter to Guinn, supra note 142.

250 See discussion, supra pp. 225-27 (discussing the FDA Guidance).

251 21 U.S.C. § 379r(a)(2).

252 E.g., Testimony of William Hubbard, supra note 7, at 4. See also Gade v. Nat’l Solid Waste Mgmt. Ass’n, 505 U.S. 88, 108 (1992).

253 See, e.g., Goodno supra note 82, at 813-814 (discussing Minnesota's goal of saving citizens money). See also S.B. 410, 79th Leg., Reg. Sess. (Tx. 2005) (talking about dispensing drugs approved by Canadian officials).

254 Compare Letter from Lutter to Guinn, supra note 142 (discussing Congressional comprehensive regulation of drug importation) with Hines v. Davidowitz, 312 U.S. 52, 66-67, 74 (1941) (discussing Congressional comprehensive regulation of aliens).

255 Letter from Lutter to Guinn, supra note 142. See also, letter from Lutter to Perry, supra note 184 (making the same arguments to the Governor of Texas in connection with their licensure legislation).

256 See discussion, supra p.243 (reviewing the terms of Minn. Canadian pharmacies contracts).

257 See discussion, supra p. 233 (explaining how the Nevada BOP application falls short of statutory requirements).

258 RHODE ISLAND BOARD OF PHARMACY, supra note 171, at 3 (Rhode Island BOP Canadian pharmacy application, revised July 2005).

259 S. 410, supra note 172, at § 43 (discussing this Texas provision of the law).

260 Cf. discussion, infra p. 245 (explaining that Maine and Washington are not subject to a preemption challenge because they will not proceed until importation is approved or the restrictions are waived by the federal government).

261 Gade, 505 U.S. at 103, 107 (assessing the obstacle by evaluating whether its effect is direct and substantial) (internal cites omitted).

262 See id. at 106-107 (relying on effect of state law more than purpose to assess preemption).

263 See, e.g., Goodno & Janisch, supra note 82, at 813-14 (explaining Minnesota's purpose as consumer savings).

264 See discussion, supra pp. 224-25 (reviewing FDCA's purpose). See also Gade, 505 U.S. at 103, 106-107 (noting that state laws may be preempted if they interfere with a federal law's method of meeting its purpose).

265 Capital Cities Cable, Inc. v. Crisp, 467 U.S. 691 (1984).

266 See id. at 694-95.

267 See id. at 698 (citing the state's power “to regulate … intoxicating liquor” as its authority to enact this law). See also id. at 715-16 (holding that when a limited state interest is measured against a federal objective that will be frustrated, the State's interest is outweighed by the federal goals).

268 Id. at 705-11.

269 See Mich. Canners and Freezers Ass’n, 467 U.S. 461 (1984).

270 Id. at 477-78.

271 See Goodno & Janisch, supra note 82. Cf. Mich. Canners and Freezers Ass’n, 467 U.S. at 477-78 (preempting a Michigan law that conflicted directly with federal law).

272 Letter from Randall W. Lutter to Kenny Guinn, supra note 142; letter from Randall W. Lutter to Rick Perry, supra note 184.

273 See letter from R. Daniel Prentiss to Susan DelMonico, supra note 161.

274 See discussions supra p. 231 (Maine initiative) and pp. 19-20 (Washington State initiative).

275 See discussion, supra at 231 (Maine initiative).

276 See discussion, supra at 237-38 (Washington State initiative).

277 See U.S. DEPT. OF HEALTH & HUMAN SERVICES, supra note 3, at 60-61 n.1. (citing Letter from Diane Gorman, Ass't Dep. Minister, Health Canada, to Richard Carmona, Surgeon General, U.S. Public Health Service, June 1, 2004).

278 Hubbard testimony, supra note 13, at 1.

279 See Letter from Mark McClellan, Comm’r. of FDA, to Diane Gorman, Ass't Dep’t. Minister, Health Canada (Nov. 17, 2003) (expressing concern to Canadian Health official about notifying Americans of Canadian drug recall) (in author's file).