House of Representatives
Office of Program Research
Health Care & Wellness Committee
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: Concerning the compounding of medications for physician offices or ambulatory surgical centers or facilities to be used by a physician for ophthalmic purposes for nonspecific patients.
Sponsors: Representatives Cody, Morrell and Schmick.
Hearing Date: 2/19/13
Staff: Chris Blake (786-7392).
Compounding is a practice in which a pharmacist prepares a prescription by combining two or more ingredients. Compounding is authorized in specific situations and in limited quantities. The compounding of an inordinate amount of drugs, relative to the practice site in anticipation of receiving prescriptions without any historical basis, is considered "manufacturing." Manufacturers must obtain a license and meet additional state and federal regulatory requirements.
The Board of Pharmacy allows pharmacists to conduct compounding in limited situations. Pharmacists may compound drugs for individual patients when there is a pharmacist/patient/prescriber relationship and the patient presents a prescription. Pharmacists may also compound drug products that are commercially available for individual patients when it is based upon anticipated orders based upon routine, regularly observed prescribing patterns. In addition, pharmacists may compound drugs in very limited quantities prior to receiving a prescription based upon a history of receiving prescriptions from a certain pharmacist/patient/prescriber relationship.
Pharmacists are prohibited from offering compounded drug products to others for resale, except to a practitioner to administer to an individual patient.
Summary of Bill:
The Board of Pharmacy must adopt rules to authorize the compounding of ophthalmic medications for use by a physician for nonspecific patients in physician offices, ambulatory surgical centers, and ambulatory surgical facilities. The rules must establish limits on the quantities that may be made available and requirements to record the dispensing of the compounded medication, including the identity of the patients and the amounts dispensed.
The term "manufacture," as it relates to legend drugs, excludes the compounding of ophthalmic medications for use by a physician for nonspecific patients in physician offices, ambulatory surgical centers, and ambulatory surgical facilities.
Fiscal Note: Available.
Effective Date: The bill contains an emergency clause and takes effect immediately.