No. 40902 (Amendment): Rule R156-17b. Pharmacy Practice Act Rule

(Amendment)

DAR File No.: 40902
Filed: 10/24/2016 09:41:45 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

H.B. 236, passed by the Legislature during the 2016 General Session, created a charitable prescription drug recycling program and required the Division to make rules to implement the program in consultation with the Utah State Board of Pharmacy. The Division is filing these proposed new sections to accomplish this mandate.

Summary of the rule or change:

In Section R156-17b-904, the authorizing statute prohibits a pharmacy from accepting or dispensing a drug under the program after either the drug label's beyond-use date, the expiration date recommended by the manufacturer, or any later date that has been established by division rule. This section makes clear that the division in collaboration with the Utah State Board of Pharmacy has not established any dates later than the beyond-use dates or the manufacturer's recommended expiration dates. Section R156-17b-905 establishes the handling fees an eligible pharmacy may charge for accepting or dispensing a drug under the program. Section R156-17b-907a establishes the registration requirements to become an eligible pharmacy allowed to participate in the program. Section R156-17b-907b establishes the formulary of eligible prescription drugs for the program. Section R156-17b-907c establishes the program standards and procedures that eligible pharmacies must create and maintain. Section R156-17b-907d establishes that the division will coordinate annual meetings between: 1) the Department of Health and eligible pharmacies to obtain input to establish program standards and procedures for assisted living and nursing care facilities; and 2) between the Division of Substance Abuse and Mental Health and eligible pharmacies to obtain input to establish program standards and procedures for mental health and substance abuse clients. Section R156-17b-907e requires an eligible pharmacy to create and maintain a training program for its pharmacists and pharmacy technicians to complete before they participate in the program, and requires the pharmacy to maintain a two-year record of such training.

Statutory or constitutional authorization for this rule:

• Subsection 58-17b-601(1)
• Section 58-17b-101
• Subsection 58-1-106(1)(a)
• Section 58-37-1
• Subsection 58-1-202(1)(a)

Anticipated cost or savings to:

the state budget:

The Division will incur minimal costs of approximately $75 to print and distribute the rule once the proposed amendments are made effective. Any printing and distribution costs incurred will be absorbed in the Division's current budget. Additional costs of registration and regulatory enforcement were included in the Legislature's consideration of H.B. 236 (2016).

local governments:

Local governments that choose to participate in the program in coordination with an eligible pharmacy may be impacted by the costs of program management and recordkeeping. However, costs of participation would likely be offset by the savings resulting from enhanced health services to medically indigent persons within the local government's jurisdiction, which could result in a cost savings to the local government and to its community as a whole. One or more citizens may have their lives saved or be able to work or be able to better take care of their own needs and activities of daily living due to the availability of prescriptions issued pursuant to this program. This may translate into a cost savings for those persons, as well as for their friends and families and the local government that provides them services. The Division is not able to determine any exact amount of costs or savings due to varying circumstances.

small businesses:

Small-business pharmacies that choose to participate in the program may be impacted by the costs of program management and recordkeeping, as well as lost revenue if they substitute time they could be billing for professional services to provide these services under the program. These costs may be slightly offset by the allowed handling fees, and the small-business pharmacies may also receive "goodwill" benefits in their community from their volunteer services, and benefit from increased traffic to their location. The amount of the cost or savings cannot be estimated as it will vary from business to business depending on the services provided.

persons other than small businesses, businesses, or local governmental entities:

Pharmacists are not required to participate in the program. This rule creates no fiscal impact for pharmacists beyond those identified in H.B. 236 (2016). Medically indigent persons who could not obtain medication but for an eligible pharmacy's participation in this program will receive the financial benefit of obtaining medication at little to no cost, and may receive a significant financial benefit due to improved health. One or more medically indigent persons may have their lives saved or be able to work or be able to take better care of their needs and activities of daily living due to the availability of prescriptions issued pursuant to this program. This may translate into a cost savings for those persons, as well as for their friends and families and the businesses who provide them goods and services. However, the Division is not able to determine any exact amount of savings due to varying circumstances.

Compliance costs for affected persons:

A pharmacy that chooses to participate in the program may be impacted by the costs of program management and recordkeeping, as well as lost revenue if the pharmacy substitutes time it could be billing for professional services to provide these services under the program. These costs may be slightly offset by the allowed handling fees, and the pharmacy may also receive "goodwill" benefits in its community from such volunteer services, and benefit from increased traffic to the pharmacy's location. The amount of the cost or savings cannot be estimated as it will vary from business to business depending on the services provided. A medically indigent individual who could not obtain medication but for an eligible pharmacy's participation in this program will receive the financial benefit of obtaining medication at little to no cost, and may receive a significant financial benefit due to improved health. An individual may have his or her life saved or be able to work or be able to take better care of his or her own needs and activities of daily living due to the availability of prescriptions issued to them pursuant to this program. This may translate into a cost savings for this individual, as well as for his or her friends and families and the businesses who provide the individual with goods and services. However, the Division is not able to determine any exact amount of savings due to varying circumstances.

Comments by the department head on the fiscal impact the rule may have on businesses:

These new rules establish procedures that permit a pharmacy to participate in a recycling program of prescription drugs in order to benefit indigents requiring medication. The rules are created to fulfill the mandate to the Division to adopt rules to implement H.B. 236 (2016), passed by the Legislature in the 2016 General Session. Although certain costs of record keeping and training of pharmacists and licensed pharmacy technicians are inherent in the rules, no costs to business are anticipated beyond those addressed in adoption of H.B. 236 (2016). Participation in the program is wholly voluntary by the pharmacy. Further, the pharmacy is permitted to charge a small handling fee, which will offset costs of the program to the participating pharmacies. Minimal fiscal impact to businesses is anticipated.

Francine A. Giani, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Commerce
Occupational and Professional Licensing
HEBER M WELLS BLDG
160 E 300 S
SALT LAKE CITY, UT 84111-2316

Direct questions regarding this rule to:

• Dane Ishihara at the above address, by phone at 801-530-7632, by FAX at 801-530-6511, or by Internet E-mail at [e-mail]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

12/15/2016

Interested persons may attend a public hearing regarding this rule:

• 11/15/2016 09:00 AM, Heber Wells Bldg, 160 E 300 S, Conference Room 474 (fourth floor), Salt Lake City, UT

This rule may become effective on:

12/22/2016

Authorized by:

Mark Steinagel, Director

RULE TEXT

R156. Commerce, Occupational and Professional Licensing.

R156-17b. Pharmacy Practice Act Rule.

R156-17b-904. Criteria for Eligible Prescription Drug - Beyond-use Date or Expiration Date.

The division in collaboration with the board has not established a date later than the beyond use date or the expiration date recommended by the manufacturer for a specific prescription drug.

 

R156-17b-905. Fees.

As authorized by Subsection 58-17b-905(2)(e), an eligible pharmacy may charge the following handling fees:

(1) Before accepting a prescription drug under the program: $0 - $10; and

(2) Before dispensing a prescription drug under the program: $0 - $5.

 

R156-17b-907a. Registration Requirements - Eligible Pharmacy.

(1) A pharmacy seeking registration with the division as an eligible pharmacy shall submit an application on a form provided by the division.

(2) The division's form shall at a minimum require the applicant pharmacy to establish that:

(a) the applicant is currently licensed and in good standing with the division;

(b) the applicant agrees to maintain, subject to inspection by the division, written standards and procedures in compliance with Section R156-17b-907c;

(c) the applicant agrees to create and maintain, subject to inspection by the division, a special training program in accordance with Section R156-17b-907e; and

(d) as required by Subsection 58-17b-902(8), the applicant is operated by a county, county health department, a pharmacy under contract with a county health department, the Department of Health, the Division of Substance Abuse and Mental Health, or a charitable clinic.

 

R156-17b-907b. Formulary.

The formulary established under Subsection 58-17b-907(2) shall include all prescription drugs approved by the federal Food and Drug Administration that meet Section 58-17b-904 criteria, except for:

(1) controlled substances;

(2) compounded drugs; and

(3) drugs that can only be dispensed to a patient registered with the drug's manufacturer per federal Food and Drug Administration requirements.

 

R156-17b-907c. Standards and Procedures - Eligible Pharmacies.

An eligible pharmacy shall maintain written standards and procedures available for inspection by the division that:

(1) satisfy the requirements of Section 58-17b-907; and

(2) satisfy labeling requirements of Subsections 58-17b-602(5) through (8), and ensure that labels clearly identify the eligible drug was dispensed under the program.

 

R156-17b-907d. Standards and Procedures - Facilities and Mental Health and Substance Abuse Clients.

(1) In accordance with Subsection 58-17b-907(4)(a), the division shall schedule and facilitate an annual meeting between the Department of Health and eligible pharmacies to establish program standards and procedures for assisted living facilities and nursing care facilities; and

(2) In accordance with Subsection 58-17b-907(4)(b), the division shall schedule and facilitate an annual meeting between the Division of Substance Abuse and Mental Health and eligible pharmacies to establish program standards and procedures for mental health and substance abuse clients.

 

R156-17b-907e. Special Training Program.

An eligible pharmacy shall:

(1) create and maintain a special training program that its pharmacists and licensed pharmacy technicians shall complete before participating in the program; and

(2) maintain a record for at least two years of all pharmacists and licensed pharmacy technicians that have completed the special training program.

 

KEY: pharmacists, licensing, pharmacies

Date of Enactment or Last Substantive Amendment: [ July 11, ]2016

Notice of Continuation: January 5, 2015

Authorizing, and Implemented or Interpreted Law: 58-17b-101; 58-17b-601(1); 58-37-1; 58-1-106(1)(a); 58-1-202(1)(a)

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