HB 96-LICENSING:DRUGS/DEVICES FOR HOME DIALYSIS  5:05:23 PM CHAIR PRAX passed the gavel to Vice Chair Ruffridge. VICE CHAIR RUFFRIDGE announced that the final order of business would be HOUSE BILL NO. 96, "An Act relating to licensing and registration requirements for certain wholesale drug distributors; and providing for an effective date." CHAIR PRAX moved to adopt Amendment 1 to HB 96, labeled 33- LS0426\A.1, Bergerud, 4/05/23, which read: Page 2, line 8: Delete ", drug," Insert "drug composed solely of fluids,  electrolytes, and sugars" Page 2, line 13: Delete the second occurrence of "and" Page 2, lines 14 - 16: Delete all material and insert: "(B) the wholesale drug distributor (i) delivers the dialysate drug or device  directly to a patient with end-stage renal disease, or  to the patient's designee, for the patient's self- administration of dialysis therapy;  (ii) uses a bar code scanning and  verification system confirming that the dialysate drug  or device selected to fill the patient-specific order  matches the information on the patient-specific label;  and  (iii) has additional secondary accuracy and  delivery checks in place; and  (C) a licensed pharmacist serves as a  consultant to the wholesale drug distributor to  (i) conduct a retrospective audit of 10  percent of the dialysate drug and device orders  provided directly to patients processed by the  wholesale drug distributor every month; and  (ii) perform assessments at least twice  monthly to ensure quality of product storage,  handling, and distribution by the wholesale drug  distributor;" 5:05:56 PM The committee took an at-ease from 5:05 p.m. to 5:06 p.m. 5:06:25 PM VICE CHAIR RUFFRIDGE announced there being no objection, Amendment 1 was adopted. 5:06:49 PM CHAIR PRAX spoke to the [adopted] Amendment 1. 5:08:13 PM The committee took an at-ease from 5:08 p.m. to 5:09 p.m. 5:09:04 PM CHAIR PRAX moved to report HB 96, as amended, out of committee with individual recommendations and the accompanying fiscal notes. REPRESENTATIVE SADDLER objected. He requested clarification on the language "delivered in its original sealed and labeled packaging". He questioned whether the package would be delivered to the patient from the wholesaler as a pallet, without being broken down into individual units. CHAIR PRAX deferred to a representative from Baxter Health Care. 5:10:49 PM ELIZABETH STOLL, Director, State Government Affairs, Baxter Health Care, stated that the word "pallet" would not be the correct terminology. She stated that the bags of solution are packed into boxes at the manufacturing facility, labeled, sealed, and sent to Anchorage. She continued that the boxes would remain unopened since packed initially. Once in Anchorage, they would be stored at the wholesale warehouse where they would be labeled, and then they would be delivered to the patient. She stated that there would never be any mixing of sizes or solutions. She maintained that once the solution is packed, the box would remain unopened until the patient unpacks it. 5:12:21 PM REPRESENTATIVE SADDLER questioned whether the language "patient's designee" refers to a third-party distributor which would deliver to the patient. MS. STOLL responded that this is the standard language accepted across the country. She stated that when the solution is shipped, the patient or their designee will receive the shipment. She stated that the designee would be the person at the home of the patient, such as a spouse. She stated that the wholesale distributor would deliver the package directly to the patient or patient's designee. REPRESENTATIVE SADDLER clarified that the package would go from the manufacturer directly to the patient or designee. He questioned whether there would be any other intermediary. MS. STOLL responded that there is no intermediary distributor. She stated that sometimes contractors are used for delivery, especially in Alaska, but Baxter Health Care is in complete ownership and control of the drug until it reaches the patient's home. 5:14:37 PM REPRESENTATIVE SADDLER removed his objection. There being no further objection, CSHB 96(HSS) was reported out of the House Health and Social Services Standing Committee.