SB 94-PROFESSION OF PHARMACY  1:54:01 PM CHAIR BJORKMAN reconvened the meeting and announced the consideration of SENATE BILL NO. 94 "An Act relating to the Board of Pharmacy; relating to the practice of pharmacy; relating to pharmacies; relating to prescription drug manufacturers; relating to prescriptions for epinephrine; relating to the administration of epinephrine; and providing for an effective date." He stated that this is the third hearing of the bill and there is one friendly amendment for the committee to consider. He invited Ms. Conway to provide a recap of SB 94. 1:54:59 PM JANE CONWAY, Staff, Senator Cathy Giessel, Alaska State Legislature, Juneau, Alaska, gave a recap of SB 94. She explained that SB 94 updates pharmacy statutes by bringing them into the modern era. She said that the Board of Pharmacy and the Alaska Pharmacist Association collaborated for months on the bill which covers out-of-state pharmacies, wholesalers, and distribution centers among other areas. SB 94 clarifies powers for the Board of Pharmacy and adds a national criminal background check for pharmacists. 1:56:21 PM CHAIR BJORKMAN found no questions and requested a motion to adopt the proposed amendment. 1:56:35 PM SENATOR GRAY-JACKSON moved to adopt Amendment 1, work order 33- LS0293\U.1, for SB 94. 33-LS0293\U.1 Bergerud 4/21/23 AMENDMENT 1 OFFERED IN THE SENATE TO: SB 94 Page 1, line 2, following "manufacturers;": Insert "relating to licensing and registration  requirements for certain wholesale drug distributors;" Page 4, following line 11: Insert a new bill section to read:  "*Sec. 4. AS 08.80.157(h) is amended to read: (h) The board may suspend, revoke, deny, or refuse to renew the license of a facility or pharmacy on the following grounds: (1) the finding by the board of violations of a federal, state, or local law relating to the practice of pharmacy, drug samples, wholesale or retail drug or device distribution, or distribution of controlled substances; (2) a felony conviction under federal, state, or local law of an owner of the facility or pharmacy or of an employee of the facility or pharmacy; (3) the furnishing of false or fraudulent material in an application made in connection with drug or device manufacturing or distribution; (4) suspension or revocation by federal, state, or local government of a license currently or previously held by the applicant for the manufacture or distribution of drugs or devices, including controlled substances; (5) obtaining remuneration by fraud, misrepresentation, or deception; (6) dealing with drugs or devices that are known or should have been known to be stolen drugs or devices; (7) dispensing or distributing drugs or devices directly to patients by a wholesale drug distributor other than a pharmacy unless (A) the drug or device is a  dialysate, drug composed solely of fluids,  electrolytes, and sugars, or device that is  (i) necessary to perform  home dialysis;  (ii) approved by the United  States Food and Drug Administration, as  required by federal law; and  (iii) delivered in its  original, sealed, and labeled packaging  only upon the receipt of a physician's  order; and  (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, and to ensure product  expiration dates are later than three  months after the date of assessment;  (8) violation of this chapter or a regulation adopted under this chapter." Renumber the following bill sections accordingly. Page 9, line 20: Delete "sec. 18" Insert "sec. 19" Page 9, line 21: Delete "sec. 18" Insert "sec. 19" Page 9, line 31: Delete "Section 20" Insert "Sections 4 and 21" Page 10, line 1: Delete "sec. 21" Insert "sec. 22" CHAIR BJORKMAN asked Ms. Conway to explain Amendment 1 to SB 94. 1:56:51 PM MS. CONWAY explained the following changes Amendment 1 would make to SB 94: [Original punctuation provided.] Senate Bill 94 Profession of Pharmacy   Explanation of Changes if Amendment LS0293\U.1 is  adopted:  Amendment U.1 adds language to the bill regarding the direct shipping of dialysate and other dialysis treatment devices and supplies to the patient. This language comes from CSHB 96 (Rep. Prax) and is being added to mirror changes made in the companion bill to SB 94. The amendment requires that the dialysate and dialysis devices and supplies • Must be approved by the FDA • Must arrive in a sealed and labeled package and ordered via a physician • Must be directly sent to the patient (with end-stage renal disease or acute kidney injury) or patient designee. Currently there are 154 home-dialysis patients (as of 2020 statistics) • Must be marked with a scannable bar code matched to the patient-specific label • A licensed pharmacist must serve as a consultant to ensure wholesale drug distributors test each month the dialysate and devices sent to patients AND they must perform quality assessments 2X a month to ensure proper storage, handling and distribution. The dialysate must have an expiration date that is good for 3 months following the assessment date. And because of the provisions set out in this SB 94, the facility would be licensed and under the jurisdiction of the AK Board of Pharmacy. Currently 24 states use this model, 8 other states have something similar. There have been no known cases of harm reported. 2 states have legislation pending to allow this program. A short deck of slides is attached for additional information for your review. 2:01:19 PM At ease. 2:02:43 PM CHAIR BJORKMAN reconvened the meeting and held SB 94 in committee with Amendment 1 pending.