Washington State

House of Representatives

Office of Program Research

BILL

ANALYSIS

Health Care & Wellness Committee

HB 1352

This analysis was prepared by non-partisan legislative staff for the use of legislative members in their deliberations. This analysis is not a part of the legislation nor does it constitute a statement of legislative intent.

Brief Description: Compounding drugs.

Sponsors: Representatives Thai, Harris, Slatter, Appleton, Jinkins and Ortiz-Self.

Brief Summary of Bill

  • Changes requirements regarding the compounding of drugs by a licensed pharmacist.

Hearing Date: 2/6/19

Staff: Jim Morishima (786-7191).

Background:

Compounding is the practice of combining two or more ingredients in the preparation of a prescription. A pharmacist may compound drug products for an individual patient based on the existence of a pharmacist-patient-prescriber relationship pursuant to a prescription or in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns. Both the patient and the prescriber must authorize the use of a compounded product before it can be substituted for a commercially available product. Medicinal products that are compounded for patient use or administration must meet the standards of the official United States Pharmacopeia as it applies to non-sterile and sterile administered products.

Summary of Bill:

Compounding is limited to combining two or more active ingredients, instead of two or more ingredients. Compounding does not include mixing, reconstitution, or other acts that are performed in accordance with directions contained in approved labelling provided by the product's manufacturer and other manufacturer directions consisting with the labeling.

The Pharmacy Quality Assurance Commission must adopt rules identifying which chapter or provisions of the United States Pharmacopeia are applicable to non-sterile and sterile products and preparations compounded for patient administration or distribution to a licensed practitioner for patient use or administration. Both medicinal products and preparations must meet the United States Pharmacopeia, instead of only medicinal products.

Appropriation: None.

Fiscal Note: Requested January 31, 2019.

Effective Date: The bill takes effect 90 days after adjournment of the session in which the bill is passed.