HOUSE DOCKET, NO. 2611        FILED ON: 1/14/2009

HOUSE  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  No. 1098

The Commonwealth of Massachusetts

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In the Year Two Thousand Nine

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An Act Relative to prescription drugs..

Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority of the same, as follows:
 

SECTION 1. The governor or his designee is hereby directed to request the United States Department of Health and Human Services to provide a waiver to the office of pharmaceutical information to act as an agent for residents of the commonwealth in providing information regarding the purchase of prescription drugs from the commonwealth and Canadian sources, as provided in Sections 2 and 3.  Once said waiver is provided, said Sections 2 and 3 shall apply.

SECTION 2. Subject to appropriation, there shall be in the department of public health the office of pharmaceutical information for the purpose of providing information to residents of the commonwealth regarding the purchase of prescription drugs including from Canadian sources, if licensed as provided in Section 1.  Notwithstanding any general or special law to the contrary, the office of pharmaceutical information shall act as a central agency through which residents of the commonwealth may obtain information on procuring prescription drugs at reduced prices. 

SECTION 3.  (a) The office, in providing advice on purchasing prescription drugs from Canada, shall establish relationships only with Canadian suppliers that are licensed by appropriate Canadian agencies. The office shall maintain a registry providing the name, place of business, phone number, fax number, or email address of: the establishment, the manufacturers of the drugs the establishments distribute and of any of the establishment’s agents in the United States. The office shall periodically update this information on the establishments. 

(b) The office shall provide advice only on prescription drugs that have been approved by appropriate federal agencies in Canada as to the drugs’ formulation, source and specification of active ingredients, processing methods, manufacturing controls, container/closure/packaging system, appearance, storage, shipping and handling practices; and the office shall advise only on prescription drugs that are packaged and shipped using tamper-proof containers and are certified by the importer as meeting all the requirements of the bill. 

(c) In order to ensure the safety of prescription drugs procured from licensed Canadian pharmacies, the office will only work with consumers in the commonwealth who are purchasing prescriptions that:

         i.      are for personal use onlyii.      will not be used for resaleiii.      are for a quantity limited to 90 days or lessiv.      accompanied by a copy of a valid prescription

(d) The office may conduct, or contract with an entity to conduct, a study of prescription drug imports permitted pursuant to this bill. The study shall include, but not be limited to, evaluation of the importers’ compliance with state and federal laws, including Canadian laws.

(e)  The office  shall serve as a central agent to which any safety concerns or adverse events occur regarding the process of procuring medications from Canada may be reported by Massachusetts consumers and health care professionals.  If any safety concerns or adverse events occur with respect to the process of importing prescriptions from Canada,  such as if a particular distributor is found to no longer meet the required safety standards, a safety report of the problem shall be filed and a record kept in the office.  Consumers and health care providers in the database will be notified of any such safety reports by the office.

(f) The office of pharmaceutical information may promulgate a consent agreement explaining the potential risks and injuries associated with obtaining services, materials, or information from the office and disclaiming liability for those risks and injuries.  The office may require any resident of the commonwealth to sign the consent agreement before receiving services, information or materials from the office.  The office shall keep any signed consent agreement on file.

(g) The office of pharmaceutical information may develop an indemnification agreement designed to indemnify the office for any injury or damage that results from a resident’s use of a supplier’s product, and hold harmless any pharmacists who rely upon the information contained in the website to advise consumers.  The office may require any supplier listed with the office to sign the indemnity agreement before its products are listed with the office.  The office shall keep any signed indemnification agreement on file.  The provisions of chapter 258 of the General Laws shall apply to this Act.

(h) the department of public health is authorized to promulgate regulations to implement this Act, including but not limited to, the process by which the office of pharmaceutical information may determine which pharmacies would be included on the informational website; the certification process, if any, that Massachusetts pharmacists would participate in prior to advising patients seeking assistance; and any other rules and regulations necessary for implementation of this Act.