October 20, 2005
PRESCRIPTION DRUG IMPORTATION LEGISLATION-OTHER STATES
By: John Kasprak, Senior Attorney
You asked for 2005 legislation passed in other states addressing prescription drug importation or reimportation.
In 2005, at least six states passed legislation addressing the importation or reimportation of prescription drugs: California, Maine, Nevada, Texas, Vermont, and Washington. (The states identified are based on a National Conference of State Legislatures' October 12, 2005 report on prescription drug legislation.)
California's legislation would establish a prescription drug Web site to provide information to residents about affordable prescription drugs, including links to pharmacies located in other countries such as Canada, the United Kingdom, and Ireland. This legislation was vetoed by California's governor.
Maine's legislation establishes a prescription drug program to provide access to prescription drugs from out of the state and the country, including Canada, to Maine residents 62 years of age and older and to those with disabilities. The law took effect last month.
Nevada's legislation authorizes its state pharmacy board to license pharmacies based in Canada if they meet all state standards, pass inspections, and provide detailed records. It also calls for the establishment of a Web site to assist residents in obtaining information about Canadian pharmacy sources and costs. Implementation of this law has been slowed by a request for an attorney general's opinion concerning certain aspects of it.
The Texas law authorizes creation of a state-run Web site to assists Texas consumers buy prescription drugs from Canada, including listing approved Canadian drug distributors. The law requires the state pharmacy board to inspect up to 10 Canadian pharmacies and designate them for participation in the Texas program.
Vermont's new law authorizes the state to join the “I-SaveRx” program, a multi-state initiative for prescription drug importation begun by Illinois.
Finally, Washington has passed a law authorizing its pharmacy board to regulate nonresident Canadian pharmacies.
PRESCRIPTION DRUG IMPORTATION-REIMPORTATION LEGISLATION
California legislation requires the state Department of Health Services (DHS) to establish a Web site to assist consumers in purchasing prescription drugs. Specifically, the “California Rx Prescription Drug Web Site” would provide information to residents about options for obtaining prescription drugs at affordable prices, including information about and electronic links to federal (Medicare) and state pharmaceutical programs and pharmacies located in Canada, the United Kingdom, and Ireland that meet state requirements, as well as other Web sites. DHS must establish the Web site by July 1, 2006.
International pharmacies must meet the following requirements to appear on the Web site:
1. be licensed by the province or country in which they are located;
2. comply with state requirements for a nonresident pharmacy, as specified;
3. require a prescription from a patient's personal physician who is licensed to practice in the U.S.;
4. require a signed patient agreement;
5. ship prescription drugs in tamperproof original manufacturer containers to individuals in the U.S., unless the consumer requests to receive the drug in a childproof container;
6. include a physical address and pharmacy license number on its company Web site;
7. not furnish any of the following: (a) a controlled substance, (b) a biological product, (c) an infused drug, (d) an intravenously injected drug, (e) a drug that is inhaled during surgery, (f) a drug that requires refrigeration or cannot be safely shipped by mail, (g) more than the prescribed drug amount or more than a three-month supply, (h) a drug that the consumer has not previously taken, and (i) a drug for which there is no equivalent approved for sale in the U.S. by the federal Food and Drug Administration (FDA);
8. sell only prescription drugs that have been approved for sale in the country in which the pharmacy is located by the agency responsible for ensuring the safety of prescription drugs in that country;
9. comply with state law regarding documentation of prescription drug pedigrees;
10. not require a consumer to sign a waiver of liability or a release of such for a negligent act of the pharmacy;
11. maintain a service department to respond to consumer inquiries and provide information about filing complaints with the appropriate licensing authority;
12. ensure that all physicians, pharmacists, and technicians it employs are properly licensed and in good standing;
13. comply with all personal health and medical information privacy law applicable to pharmacies located in California; and
14. any other requirements DHS establishes to ensure the safety, accessibility, and affordability of prescription drugs.
The legislation also requires the Web site to include price comparisons of at least 50 commonly prescribed brand name prescription drugs, including typical prices charged by licensed pharmacies in the state and by international pharmacies that provide mail order service to the U.S. and whose Web sites are linked to the department's.
Governor Schwarzenegger vetoed this legislation on September 29, 2005. A portion of his veto message states, “I am supportive of reducing the cost of prescription medications for California residents; however, this bill over-simplifies the complex safety, trade, supply, and pricing issues involved in this marketplace. I am concerned that this bill would establish a mechanism to facilitate an illegal practice, expose the state to potential tort liability, and potentially jeopardize patient safety. Finally, there would be increased fiscal impact on the General Fund for development and implementation of a state drug importation safety program.”
A copy of the legislation (AB 73) and the governor's veto message are attached.
A recently enacted Maine law (Chapter 165 of the 2005 Laws; H.P. 369-L.D. 494) requires the state Department of Human Services (DHS) to establish a prescription drug program to provide access to prescription drugs from out of the country to Maine residents who are 62 years of age or older or have disabilities. The legislation specifies that the program “must operate within the limits of federal law and regulation and state law and rule.”
Access to prescription drugs under this program is subject to the following requirements.
1. The program member must show evidence of use of a pharmacist licensed in the state to coordinate all prescriptions and prevent harmful drug interactions.
2. The program may provide access to prescription drugs that a member has taken according to prescription for at least 15 days.
3. The program may provide access to prescription drugs from pharmacies located outside the country, provided that DHS has specifically approved the use of any such pharmacies.
4. The program may provide access to prescription drugs that are brand name drugs in their original sealed packaging.
5. The program may not provide access to antibiotics for acute illnesses or prescription drugs for alleviation of pain that are habit forming.
The legislation requires that the program include a procedure for random testing of drugs to ensure their purity and safety. DHS must adopt regulations to implement the law. It took effect September 17, 2005.
A copy of the law is attached.
Under a new law (SB 5), the Nevada State Board of Pharmacy is authorized to license and inspect Canadian pharmacies that will appear on a Web site established by the Governor's Office for Consumer Health Assistance to help state residents purchase medications. State residents can purchase a 90-day supply of FDA-approved medications through the Web site. The board's staff would inspect Canadian pharmacies after approval of their applications, and those pharmacies could begin to sell prescription drugs to state residents after they passed inspections.
As of the end of September 2005, the Nevada program is on hold because the attorney general's office has been asked to address the issue. The state pharmacy board has asked the attorney general for an opinion on language in the bill involving what constitutes “U.S. Federal Drug Administration-approved drugs.” The inspection process of Canadian pharmacies began during the week of September 19; the legal opinion requested by the board is needed to finalize the program (see “Canadian Drug Plan Placed on Hold in Nevada,” The Las Vegas Review Journal,” September 30, 2005).
A copy of the legislation is attached.
SB 410 of Texas' 2005 Legislative Session authorizes the creation of a state-run Web site to assist Texas residents to buy prescription drugs from Canada, including listing approved Canadian prescription drug distributors. The state's pharmacy board must inspect up to 10 Canadian pharmacies and assure that they meet U.S. FDA, state, and Canadian standards as well as safe-shipping codes.
Specifically, the pharmacy board is charged with designating between one and 10 Canadian pharmacies whose primary business is to dispense prescription drugs under prescription drug orders to Canadian residents, as having passed board inspection for shipping, mailing, or delivering a prescription dispensed under a prescription drug order to a Texas resident. The board must establish a Web site to provide information necessary to enable Texas residents to conveniently order prescription drugs from these designated Canadian pharmacies. Only designated pharmacies may ship, mail, or deliver to Texas prescription drugs ordered for Texas residents.
The law requires the board to randomly inspect, at least annually, designated Canadian pharmacies to ensure their compliance with safety standards. To pass the board's inspection, a Canadian pharmacy must meet Texas licensing standards. Additionally, to qualify for the board's designation, a pharmacy applicant must submit to the board:
1. satisfactory evidence that it holds a pharmacy license, registration, or permit in good standing issued in Canada and is not subject to any pending disciplinary or legal action by any regulatory authority;
2. the name and address of the pharmacy's owner and pharmacist-in-charge;
3. evidence of the applicant's ability to provide the board, within 72 after the board requests it, a record of a prescription drug order authorizing the pharmacy to dispense a drug to a Texas resident;
4. an affidavit by the pharmacist-in-charge that states the pharmacist has read and understands the Texas law concerning inspection and designation of Canadian pharmacies;
5. evidence satisfactory to the board that the applicant meets the board's standards concerning customer safety for orders filled; and
6. satisfactory evidence that the applicant's employees hold the appropriate Canadian licenses required to dispense drugs.
A copy of the law is attached.
Act 2 of Vermont's 2005 Laws (S. 49) authorizes the state to join “I-SaveRx,” the multi-state prescription drug program implemented by Illinois in 2004. (For more information on I-SaveRX” see OLR Report 2005-R-0285.) The legislation specifies “The state of Vermont hereby enters into an agreement with the state of Illinois regarding access for each state's residents to safe and affordable prescription drugs from Canada, Ireland, and the United Kingdom through the state of Illinois I-SaveRx program.”
Vermont will maintain a separate Web site that provides a link to Illinois' www.I-SaveRx.net. In its pharmacy benefits manager (PBM) agreement, Illinois will specify that citizens with Vermont zip codes will have access to services available through the I-SaveRx program and that Vermont residents are considered “program participants.”
To ensure adequate Vermont involvement concerning the safe and effective administration of the program, Vermont will be part of the Joint Work Group, composed of two representatives from each participating state. The Vermont representatives are the state health commissioner and the chair of the board of pharmacy.
A copy of the law is attached.
Chapter 275 of the Washington Laws of 2005 authorizes the State Board of Pharmacy to license Canadian pharmacies that provide services to Washington residents. The legislation directs the board, in consultation with the state Health Department and state Health Care Authority, to submit a waiver request to the FDA that authorizes the importation of prescription drugs from Canada. Upon approval of the federal waiver, the board, in consultation with the entities noted above, will license Canadian pharmacies that ship, mail, or deliver prescription drugs to Washington residents. If the Health Department is unable to develop a reciprocal licensing agreement with Health Canada or a Canadian province, it will license Canadian pharmacies through on-site inspection and certification.
A copy of the law is attached.