WSR 97-02-015

PERMANENT RULES

DEPARTMENT OF HEALTH

(Board of Pharmacy)

[Filed December 20, 1996, 4:22 p.m.]

Date of Adoption: September 24, 1996.

Purpose: Implement legislation passed by the 1995 legislature to license health care entities. The rule establishes a licensing category for health care entities. This will allow free standing ambulatory centers and kidney dialysis centers to order, purchase, administer and dispense medications to their patients under the supervision of a pharmacist.

Statutory Authority for Adoption: RCW 18.64.450.

Adopted under notice filed as WSR 96-17-066 on August 20, 1996.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, amended 0, repealed 0; Federal Rules or Standards: New 0, amended 0, repealed 0; or Recently Enacted State Statutes: New 0, amended 0, repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, amended 0, repealed 0.

Number of Sections Adopted on the Agency's own Initiative: New 10, amended 0, repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, amended 0, repealed 0.

Number of Sections Adopted using Negotiated Rule Making: New 0, amended 0, repealed 0; Pilot Rule Making: New 0, amended 0, repealed 0; or Other Alternative Rule Making: New 10, amended 0, repealed 0.

Effective Date of Rule: Thirty-one days after filing.

December 5, 1996

G. Kirby White

Vice-Chair

Chapter 246-904 WAC


HEALTH CARE ENTITIES

NEW SECTION

WAC 246-904-010 Definition. Health care entity - an organization that provides health care services in a setting that is not otherwise licensed by the state. Health care entity includes any of the following which are not part of another licensed facility, including: Outpatient surgery centers, cardiac care centers, or kidney dialysis centers. It does not include an individual practitioners office or a multipractitioner clinic.

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NEW SECTION

WAC 246-904-020 New health care entity licensing. No health care entity shall be issued a license until the facility has submitted an application along with the applicable fees set forth in WAC 246-907-020 through 246-907-030 and has passed an inspection by a Washington state board of pharmacy investigator. The investigator shall determine if the purchase, ordering, storing, compounding, delivering, dispensing and administration of controlled substances and/or legend drugs complies with all applicable state and federal statutes and regulations. Physical requirements for the areas of a health care entity where drugs are stored, compounded, delivered or dispensed shall comply with WAC 246-873-070.

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NEW SECTION

WAC 246-904-030 Pharmacist in charge. Every health care entity licensed under this chapter shall designate a pharmacist in charge. The pharmacist in charge may be employed in a full-time capacity or as a pharmacist consultant. The pharmacist in charge must be licensed to practice pharmacy in the state of Washington. The pharmacist in charge designated by a health care entity shall have the authority and responsibility to assure that the area(s) within the health care entity where drugs are stored, compounded, delivered or dispensed are operated in compliance with all applicable state and federal statutes and regulations.

It shall be the responsibility of the pharmacist in charge:

(1) To create and implement policy and procedures relating to:

(a) Purchasing, ordering, storing, compounding, delivering, dispensing or administering of controlled substances or legend drugs.

(b) Accuracy of inventory records, patient medical records as related to the administration of controlled substances and legend drugs, and any other records required to be kept by state and federal regulations.

(c) Adequate security of legend drugs and controlled substances.

(d) Controlling access to controlled substances and legend drugs.

(2) To assure that the Washington state board of pharmacy is in possession of all current policies and procedures identified in subsection (1) of this section.

(3) To execute all forms for the purchase and order of legend drugs and controlled substances.

(4) To verify receipt of all legend drugs and controlled substances purchased and ordered by the health care facility.

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NEW SECTION

WAC 246-904-040 Drug procurement, distribution and control. The procurement, distribution and control of drugs shall be in accordance with WAC 246-873-080.

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NEW SECTION

WAC 246-904-050 Dispensing of prescription medications from health care entities. Drugs dispensed to patients of a health care entity must be dispensed in a manner consistent with the requirements of RCW 18.64.246 through 18.64.247, chapters 69.41 and 69.50 RCW, and WAC 246-869-220 through 246-869-240.

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NEW SECTION

WAC 246-904-060 Labeling. Drugs dispensed to patients of a health care entity must comply with the labeling requirements of WAC 246-869-210.

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NEW SECTION

WAC 246-904-070 Records. To the extent applicable, all prescription records shall be maintained in accordance with WAC 246-869-100 and chapter 246-875 WAC et seq.

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NEW SECTION

WAC 246-904-080 Absence of a pharmacist. Pharmaceutical services shall be available at all times patients are present in the facility. At times when no pharmacist is in the facility, the entity must comply with the requirements of WAC 246-873-050 and 246-873-060.

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NEW SECTION

WAC 246-904-090 Administration. Administration of drugs to patients of a health care entity shall be in accordance with WAC 246-873-090.

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NEW SECTION

WAC 246-904-100 Closing. When a health care entity ceases to do business or to provide pharmaceutical services to patients, the entity shall follow the provisions of WAC 246-869-250.

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