SENATE BILL NO. 201 "An Act relating to the Board of Pharmacy; relating to the licensing and inspection of certain facilities located outside the state; relating to drug supply chain security; and creating a position of executive administrator for the Board of Pharmacy." 9:29:03 AM Co-Chair MacKinnon referred to a document from Senator Cathy Giessel dated April 9, 2016, in response to questions from the committee (copy on file). JANE CONWAY, STAFF, SENATOR CATHY GIESSEL, addressed the document that answered the questions that had come up at the previous hearing of the bill: 1. Would SB 201 apply to regulation of international wholesalers? (sub question.....do our AK licensees do business with wholesalers in Mexico or Canada or similar?) But even so, we can't regulate a business in another country could we? Alaskan pharmacies do not do business with wholesalers in Mexico or Canada since they presumably don't sell US FDA approved drugs and as such the FDA does not allow import of said drugs. Ms. Conway specified that drugs must be licensed in the United States and be approved by the United States Federal Drug Administration (FDA). Co-Chair MacKinnon restated that her question had been if an international or foreign country could market directly to Alaskans, and somehow bypass the FDA. Co-Chair MacKinnon referred to the first question, and asked for professional feedback on the matter. DIRK WHITE, PHARMACIST, SITKA (via teleconference), relayed that he recently finished his term as president of the Board of Pharmacy. He stated there had been ongoing conversation regarding importation of drugs from foreign countries. He recounted that in the Clinton era, the importation of pharmaceuticals was going to be allowed but was later quashed by the U.S. Justice Department. He discussed the Drug Quality Security Act (DQSA), and informed that there was a practice called "track and trace," under which pharmacists were ensured as to the provenance and pedigree of the items that had been ordered. He noted that he received an electronic file every time he placed an order from a wholesaler, which would show the pedigree of each item that was ordered. He discussed prevention efforts by the Board of Pharmacy to ensure that wholesalers were following DQSA regulations. He pointed out that the board had no jurisdiction over international pharmacies or wholesalers, and added that there were loopholes. 9:34:01 AM Co-Chair MacKinnon was unclear as to Mr. White's response on the matter of directly accepting drugs from wholesalers. She wondered if the bill should endeavor to prevent the ability to purchase drugs from a wholesaler that marketed internationally. She wondered if the committee should amend the bill to ban the ability to purchase internationally. Mr. White clarified that the prohibition she described was essentially what pharmacists had been operating under. According to regulations, he should not be able to purchase from an international pharmacy or wholesaler, but he was sure there was a way around the rule, which is why he had mentioned a loophole. He referred to copious amounts of packages that were being sent from out of state, and thought the FDA was unable to inspect them all. He asserted that he would always order from a major national wholesaler. There were also small regional businesses which were licensed and certified and inspected, and were able to ship into other states. He did not see that the international concern was a priority. Ms. Conway spoke to the regulation of internet sales on the first page of the document: 2. Are internet sales regulated? Sub question - would AK licensees purchase off the internet? Are they even allowed to do that? Alaskan Pharmacies may purchase off the internet from Wholesalers licensed in the United States and purchase FDA approved drugs. Alaskan pharmacies may not purchase and then dispense drugs from wholesalers (presumably out of the country) that are NOT FDA approved. Ms. Conway stated that individuals could purchase medications over the internet. She noted that there had been discussion about an internet corporation forming to address the dot-com pharmacy industry; so that a person could look up an internet pharmacy to see if it was certified as handling FDA-approved drugs. Co-Chair MacKinnon related that the committee had addressed the fiscal note on April 9, 2016. She noted that public testimony had opened and closed on the same date. Vice-Chair Micciche MOVED to report SB 201 out of Committee with individual recommendations and the accompanying fiscal note. SB 201 was REPORTED out of committee with "no recommendation" and with one previously published fiscal note: FN1 (CED). 9:38:36 AM AT EASE 9:42:06 AM RECONVENED