Alaska 30th Legislature (2017-2018) Status: In Committee 1 R cosponsors

HB 9 — 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.

Last action — Referred to Finance

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  1. ✓
    Introduced
  2. 2
    In Committee
  3. 3
    Passed House
  4. 4
    Passed Senate
  5. 5
    To Executive
  6. 6
    Enacted

This bill died with 30th Legislature (2017-2018). It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

Bill Text

What changed in the latest version

8 added · 6 removed

Plain-language change summary

The amendments to HB 9 expand the powers of the Board of Pharmacy by adding new responsibilities related to the licensing and inspection of facilities outside of Alaska that engage in drug distribution. It also creates a new executive administrator position to manage these responsibilities and improve the board's operations. These changes are significant because they aim to strengthen drug supply chain security and ensure safer practices for medications coming into the state. Overall, this could enhance public health protections by ensuring that all drug distributors meet stringent regulatory standards, regardless of where they operate.

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Alaska State Legislature The Alaska State Legislature menu Home Senate Current Members Past Members By Session Alphabetical House Current Members Past Members By Session Alphabetical Bills & Laws Bills All Introduced Actions by Date Awaiting Actions Bills sent to Conf Committee Bills in Committee Governor's Vetoes Passed Legislation Prefile Bill Summary Requestor Summary Statistics Sponsor Summary Subject Summary Laws Constitution Constitutional Convention Files Statutes Executive Orders - Current Executive Orders - Historical Administrative Code Journals Session Laws & Resolves Session Laws & Resolves 2017 Session Laws & Resolves 2018 - Previous Year Session Law - Previous Year Legislative Resolves Tools Statute Information Retrieval System Bill Tracking Management Facility Past Legislatures (Archives) Committees Hearing Schedule Standing Committees Finance Committees Special Committees Joint Committees Conference Committees Other Committees Minutes Publications Get Started Information Offices Legislative Affairs Legislative Agencies Links Legislative Branch Executive Branch Judicial Branch Alaska Delegation Home Bill & Laws Bills CSHB 9(L&C) Detail FullText txt CSHB 9(L&C):
relating to the licensing and inspection of certain facilities located outside the state;
relating to the licensing of certain entities and inspection of certain facilities located outside the state;
and creating a position of executive administrator for the Board of Pharmacy." HOUSE BILL NO.
creating a position of executive administrator for the Board of Pharmacy;
9 01 "An Act relating to the Board of Pharmacy;
and providing for an effective date." CS FOR HOUSE BILL NO.
relating to the licensing and inspection of 02 certain facilities located outside the state;
9(L&C) 01 "An Act relating to the Board of Pharmacy;
relating to drug supply chain security;
relating to the licensing of certain entities 02 and inspection of certain facilities located outside the state;
and 03 creating a position of executive administrator for the Board of Pharmacy." 04 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA:
relating to drug supply chain 03 security;
05 * Section 1.
creating a position of executive administrator for the Board of Pharmacy;
and 04 providing for an effective date." 05 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA:
06 * Section 1.
06 (b) In order to fulfill its responsibilities, the board has the powers necessary 07 for implementation and enforcement of this chapter, including the power to 08 (1) elect a president and secretary from its membership and adopt rules 09 for the conduct of its business;
07 (b) In order to fulfill its responsibilities, the board has the powers necessary 08 for implementation and enforcement of this chapter, including the power to 09 (1) elect a president and secretary from its membership and adopt rules 10 for the conduct of its business;
10 (2) license by examination or by license transfer the applicants who are 11 qualified to engage in the practice of pharmacy;
11 (2) license by examination or by license transfer the applicants who are 12 qualified to engage in the practice of pharmacy;
12 (3) assist the department in inspections and investigations for 13 violations of this chapter, or of any other state or federal statute relating to the practice 14 of pharmacy;
13 (3) assist the department in inspections and investigations for 14 violations of this chapter, or of any other state or federal statute relating to the practice of pharmacy;
(4) adopt regulations to carry out the purposes of this chapter;
02 (4) adopt regulations to carry out the purposes of this chapter;
02 (5) establish and enforce compliance with professional standards and 03 rules of conduct for pharmacists engaged in the practice of pharmacy;
03 (5) establish and enforce compliance with professional standards and 04 rules of conduct for pharmacists engaged in the practice of pharmacy;
04 (6) determine standards for recognition and approval of degree 05 programs of schools and colleges of pharmacy whose graduates shall be eligible for 06 licensure in this state, including the specification and enforcement of requirements for 07 practical training, including internships;
05 (6) determine standards for recognition and approval of degree 06 programs of schools and colleges of pharmacy whose graduates shall be eligible for 07 licensure in this state, including the specification and enforcement of requirements for 08 practical training, including internships;
08 (7) establish for pharmacists and pharmacies minimum specifications 09 for the physical facilities, technical equipment, personnel, and procedures for the 10 storage, compounding, and dispensing of drugs or related devices, and for the 11 monitoring of drug therapy;
09 (7) establish for pharmacists and pharmacies minimum specifications 10 for the physical facilities, technical equipment, personnel, and procedures for the 11 storage, compounding, and dispensing of drugs or related devices, and for the 12 monitoring of drug therapy;
12 (8) enforce the provisions of this chapter relating to the conduct or 13 competence of pharmacists practicing in the state, and the suspension, revocation, or 14 restriction of licenses to engage in the practice of pharmacy;
13 (8) enforce the provisions of this chapter relating to the conduct or 14 competence of pharmacists practicing in the state, and the suspension, revocation, or 15 restriction of licenses to engage in the practice of pharmacy;
15 (9) license and regulate the training, qualifications, and employment of 16 pharmacy interns and pharmacy technicians;
16 (9) license and regulate the training, qualifications, and employment of 17 pharmacy interns and pharmacy technicians;
17 (10) issue licenses to persons engaged in the manufacture and 18 distribution of drugs and related devices;
18 (10) issue licenses to persons engaged in the manufacture and 19 distribution of drugs and related devices;
19 (11) establish and maintain a controlled substance prescription 20 database as provided in AS 17.30.200;
20 (11) establish and maintain a controlled substance prescription 21 database as provided in AS 17.30.200;
21 (12) establish standards for the independent administration by a 22 pharmacist of vaccines and related emergency medications under AS 08.80.168, 23 including the completion of an immunization training program approved by the board;
22 (12) establish standards for the independent administration by a 23 pharmacist of vaccines and related emergency medications under AS 08.80.168, 24 including the completion of an immunization training program approved by the board;
24 (13) establish standards for the independent dispensing by a 25 pharmacist of an opioid overdose drug under AS 17.20.085, including the completion 26 of an opioid overdose training program approved by the board;
25 (13) establish standards for the independent dispensing by a 26 pharmacist of an opioid overdose drug under AS 17.20.085, including the completion 27 of an opioid overdose training program approved by the board;
27 (14) license and inspect the facilities of wholesale drug distributors 28 and outsourcing facilities located outside the state under AS 08.80.159;
28 (14) establish the qualifications and duties of the executive 29 administrator and delegate authority to the executive administrator that is 30 necessary to conduct board business.
29 (15) establish the qualifications and duties of the executive 30 administrator and delegate authority to the executive administrator that is 31 necessary to conduct board business.
31 * Sec.
* Sec.
AS 08.80.030 is amended by adding a new subsection to read:
AS 08.80.030(b), as amended by sec.
02 (c) The minimum specifications for facilities, equipment, personnel, and 03 procedures for the compounding, storage, and dispensing of drugs established under 04 (b)(7) of this section must be consistent with the requirements of 21 U.S.C.
1 of this Act, is amended to read:
201 - 208 05 (Drug Supply Chain Security Act).
(b) In order to fulfill its responsibilities, the board has the powers necessary 02 for implementation and enforcement of this chapter, including the power to 03 (1) elect a president and secretary from its membership and adopt rules 04 for the conduct of its business;
06 * Sec.
05 (2) license by examination or by license transfer the applicants who are 06 qualified to engage in the practice of pharmacy;
07 (3) assist the department in inspections and investigations for 08 violations of this chapter, or of any other state or federal statute relating to the practice 09 of pharmacy;
10 (4) adopt regulations to carry out the purposes of this chapter;
11 (5) establish and enforce compliance with professional standards and 12 rules of conduct for pharmacists engaged in the practice of pharmacy;
13 (6) determine standards for recognition and approval of degree 14 programs of schools and colleges of pharmacy whose graduates shall be eligible for 15 licensure in this state, including the specification and enforcement of requirements for 16 practical training, including internships;
17 (7) establish for pharmacists and pharmacies minimum specifications 18 for the physical facilities, technical equipment, personnel, and procedures for the 19 storage, compounding, and dispensing of drugs or related devices, and for the 20 monitoring of drug therapy;
21 (8) enforce the provisions of this chapter relating to the conduct or 22 competence of pharmacists practicing in the state, and the suspension, revocation, or 23 restriction of licenses to engage in the practice of pharmacy;
24 (9) license and regulate the training, qualifications, and employment of 25 pharmacy interns and pharmacy technicians;
26 (10) issue licenses to persons engaged in the manufacture and 27 distribution of drugs and related devices;
28 (11) establish and maintain a controlled substance prescription 29 database as provided in AS 17.30.200;
30 (12) establish standards for the independent administration by a 31 pharmacist of vaccines and related emergency medications under AS 08.80.168, including the completion of an immunization training program approved by the board;
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02 (13) establish standards for the independent dispensing by a 03 pharmacist of an opioid overdose drug under AS 17.20.085, including the completion 04 of an opioid overdose training program approved by the board;
05 (14) establish the qualifications and duties of the executive 06 administrator and delegate authority to the executive administrator that is necessary to 07 conduct board business;
08 (15) license and inspect the facilities of wholesale drug 09 distributors, third-party logistics providers, and outsourcing facilities located 10 outside the state under AS 08.80.159.
11 * Sec.
AS 08.80.157 is amended by adding a new subsection to read:
AS 08.80.030 is amended by adding a new subsection to read:
07 (k) This section applies to wholesale drug distributors and outsourcing 08 facilities located outside the state under AS 08.80.159.
12 (c) The minimum specifications for facilities, equipment, personnel, and 13 procedures for the compounding, storage, and dispensing of drugs established under 14 (b)(7) of this section must be consistent with the requirements of 21 U.S.C.
09 * Sec.
201 - 208 15 (Drug Supply Chain Security Act).
16 * Sec.
AS 08.80.157 is amended by adding a new subsection to read:
17 (k) This section applies to wholesale drug distributors, third-party logistics 18 providers, and outsourcing facilities located outside the state under AS 08.80.159.
19 * Sec.
5.
10 Sec.
20 Sec.
(a) 11 Before shipping, mailing, or delivering prescription drugs to a licensee in the state or 12 advertising in the state, a wholesale drug distributor or outsourcing facility that is 13 located outside the state shall 14 (1) obtain a license under AS 08.80.157;
(a) 21 Before shipping, mailing, or delivering prescription drugs to a licensee in the state or 22 advertising in the state, a wholesale drug distributor, third-party logistics provider, or 23 an outsourcing facility that is located outside the state shall 24 (1) obtain a license under AS 08.80.157;
15 (2) appoint an agent on whom process can be served in the state;
25 (2) appoint an agent on whom process can be served in the state;
and 16 (3) authorize inspection of the facility by a designee of the board under 17 (b) of this section.
and 26 (3) authorize inspection of the facility by a designee of the board under 27 (c) of this section.
18 (b) In addition to the requirements of (a) of this section, an outsourcing facility 19 shall 20 (1) register as an outsourcing facility with the United States Food and 21 Drug Administration;
28 (b) In addition to the requirements of (a) of this section, an outsourcing facility 29 shall 30 (1) register as an outsourcing facility with the United States Food and 31 Drug Administration;
and 22 (2) comply with the requirements of 21 U.S.C.
and (2) comply with the requirements of 21 U.S.C.
503B (Drug Quality 23 and Security Act of 2013).
503B (Drug Quality 02 and Security Act of 2013).
24 (c) Upon application by a wholesale drug distributor or outsourcing facility for 25 a license under this section, the board may 26 (1) require an inspection of a facility located outside the state;
03 (c) Upon application by a wholesale drug distributor, third-party logistics 04 provider, or an outsourcing facility for a license under this section, the board may 05 (1) require an inspection of the applicant's facility located outside the 06 state;
and 27 (2) approve a designee to conduct the inspection.
and 07 (2) approve a designee to conduct the inspection.
28 (d) The board shall adopt regulations necessary to implement this section.
08 (d) The board shall adopt regulations necessary to implement this section.
29 * Sec.
09 * Sec.
5.
6.
30 Sec.
10 Sec.
(a) The board shall 31 employ an executive administrator to carry out the duties established under (b) of this section.
(a) The board shall 11 employ an executive administrator to carry out the duties established under (b) of this 12 section.
02 (b) The executive administrator shall 03 (1) perform duties associated with the licensing and regulation of 04 licensees under this chapter as prescribed by the board;
The executive administrator is the principal executive officer of the board.
and 05 (2) serve as a liaison to the legislative and executive branches of state 06 government, the media, and other state pharmacy boards.
13 The executive administrator is in the partially exempt service under AS 39.25.120 and 14 is entitled to receive a monthly salary equal to a step in Range 23 on the salary 15 schedule set out in AS 39.27.011(a).
07 * Sec.
16 (b) The executive administrator shall 17 (1) perform duties associated with the licensing and regulation of 18 licensees under this chapter as prescribed by the board;
6.
and 19 (2) serve as a liaison to the legislative and executive branches of state 20 government, the media, and other state pharmacy boards.
AS 08.80.480 is amended by adding a new paragraph to read:
21 * Sec.
08 (37) "outsourcing facility" means a facility at one geographic location 09 or address that is engaged in the compounding of sterile drugs for a facility at another 10 geographic location.
7.
AS 08.80.480 is amended by adding new paragraphs to read:
22 (37) "outsourcing facility" means a facility at one geographic location 23 or address that is engaged in the compounding of sterile drugs for a facility at another 24 geographic location;
25 (38) "third-party logistics provider" means an entity that provides or 26 coordinates warehousing or other logistics services for a product in interstate 27 commerce on behalf of a manufacturer, wholesale distributor, or dispenser of the 28 product, and that does not take ownership of the product or have responsibility to 29 direct the sale or disposition of the product.
30 * Sec.
8.
AS 39.25.120(c)(7) is amended to read:
31 (7) the principal executive officer of the following boards, councils, or commissions:
02 (A) Alaska Public Broadcasting Commission;
03 (B) Professional Teaching Practices Commission;
04 (C) Parole Board;
05 (D) Board of Nursing;
06 (E) Real Estate Commission;
07 (F) Alaska Royalty Oil and Gas Development Advisory Board;
08 (G) Alaska State Council on the Arts;
09 (H) Alaska Police Standards Council;
10 (I) Alaska Commission on Aging;
11 (J) Alaska Mental Health Board;
12 (K) State Medical Board;
13 (L) Governor's Council on Disabilities and Special Education;
14 (M) Advisory Board on Alcoholism and Drug Abuse;
15 (N) Statewide Suicide Prevention Council;
16 (O) State Board of Registration for Architects, Engineers, and 17 Land Surveyors;
18 (P) Alaska Health Care Commission;
19 (Q) Board of Pharmacy;
20 * Sec.
9.
The uncodified law of the State of Alaska is amended by adding a new section to 21 read:
22 TRANSITION:
REGULATIONS.
The Department of Commerce, Community, and 23 Economic Development and the Board of Pharmacy may adopt regulations necessary to 24 implement the changes made by this Act.
The regulations take effect under AS 44.62 25 (Administrative Procedure Act), but not before the effective date of the relevant provision of 26 this Act implemented by the regulation.
27 * Sec.
10.
Sections 1, 6, 8, and 9 of this Act take effect immediately under AS 01.10.070(c).
28 * Sec.
11.
Except as provided in sec.
10 of this Act, this Act takes effect July 1, 2018.
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How this bill changes current law

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AI-generated reading aid from the bill's amendatory text — verify against the official bill.

The bill establishes new regulations for the licensing and inspection of out-of-state facilities related to pharmacy operations and creates a position for an executive administrator within the Board of Pharmacy.

  • AS 08.80.030(b)

    establish the qualifications and duties of the executive administrator and delegate authority to the executive administrator that is necessary to conduct board business.

    This adds a new responsibility for the Board of Pharmacy to establish qualifications for an executive administrator.

  • AS 08.80.030

    The minimum specifications for facilities, equipment, personnel, and procedures for the compounding, storage, and dispensing of drugs established under (b)(7) of this section must be consistent with the requirements of 21 U.S.C. 201 - 208 (Drug Supply Chain Security Act).

    This ensures that state standards for drug handling are aligned with federal regulations.

  • AS 08.80.157

    This section applies to wholesale drug distributors and outsourcing facilities located outside the state under AS 08.80.159.

    This expands the applicability of regulations to include out-of-state facilities in relation to drug distribution.

  • AS 08.80

    Sec. 08.80.159. Licensing and inspection of facilities outside of state. (a) Before shipping, mailing, or delivering prescription drugs to a licensee in the state or advertising in the state, a wholesale drug distributor or outsourcing facility that is located outside the state shall obtain a license under AS 08.80.157; appoint an agent on whom process can be served in the state; and authorize inspection of the facility by a designee of the board under (b) of this section.

    This establishes licensing and inspection requirements specifically for out-of-state drug distributors and outsourcing facilities.

  • AS 08.80

    Sec. 08.80.270. Executive administrator of the board. (a) The board shall employ an executive administrator to carry out the duties established under (b) of this section.

    This creates a formal position for an executive administrator to help manage Board of Pharmacy activities.

  • AS 08.80.480

    "outsourcing facility" means a facility at one geographic location or address that is engaged in the compounding of sterile drugs for a facility at another geographic location.

    This provides a specific definition for outsourcing facilities within pharmacy regulations.

Action History

  1. Referred to Finance

  2. Fiscal Note 1: (Commerce, Community & Economic Development)

  3. L&C No Recommendation: STUTES, WOOL, JOSEPHSON, KNOPP

  4. L&C Do Pass: SULLIVAN-LEONARD, BIRCH, KITO

  5. L&C RPT CS(L&C) NT 3DP 4NR

  6. L&C, FIN

  7. Read the first time - REFERRALS

  8. Prefile released

Sponsors

Sponsorship breakdown

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1 sponsors · 0 co-sponsors · 64 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (64)

64 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

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Subjects

public-safety healthcare
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Frequently asked questions

Who sponsors HB 9?
HB 9 is sponsored by Dan Saddler (R).
What is the current status of HB 9?
This bill died with 30th Legislature (2017-2018). It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HB 9?
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