HOUSE BILL REPORT

                 EHB 1415

                       As Passed House

                        March 9, 1993

Title:  An act relating to over-the-counter medication.

Brief Description:  Modifying the imprinting law for over‑the‑counter medications in solid dosage form.

Sponsors:  Representative G. Cole.

Brief History:

  Reported by House Committee on:

Health Care, February 25, 1993, DPA;

  Passed House, March 9, 1993, 98-0.

HOUSE COMMITTEE ON HEALTH CARE

Majority Report:  Do pass as amended.  Signed by 15 members:  Representatives Dellwo, Chair; L. Johnson, Vice Chair; Dyer, Ranking Minority Member; Ballasiotes, Assistant Ranking Minority Member; Appelwick; Campbell; Conway; Cooke; Flemming; R. Johnson; Lisk; Mastin; Mielke; Thibaudeau; and Veloria.

Staff:  John Welsh (786-7133).

Background:  For poison control purposes, the Legislature enacted a requirement that prohibits the manufacture or distribution of solid dosage over-the-counter (nonprescription) medications without clearly identifying the medication and the manufacturer or distributor by name or symbols.  No such drugs may be manufactured in or shipped into this state after January 1, 1993, without being identified.

The sale of over-the-counter medications in any container including vials, after January 1, 1994, is also prohibited without identifying the manufacturer.  There is no requirement however that the distributor or packer be identified on these drugs.  There is a question whether this requirement includes liquid dosages as well as solid dosages.

The Board of Pharmacy was required before January 1, 1993, to determine if the federal government has established a substantively equivalent system for imprinting and identifying drugs.  State requirements would cease to exist upon the implementation of the federal requirements.

To date, no federal system for imprinting and identifying over-the-counter drugs has been implemented, and the requirements of state law are now technically in effect.

Summary of Bill:  The implementation date for identifying over-the-counter medications manufactured and distributed in this state is deferred until January 1, 1994, and these medications may not be sold in this state after January 1, 1995.

The coverage of the law is clarified to include only over-the-counter medications in solid dosage forms, excluding liquids.

The packer and distributor as well as the manufacturer are required to be identified on the over-the-counter medications sold in this state after January 1, 1995.

Fiscal Note:  Not Requested.

Effective Date:  The bill contains an emergency clause and takes effect immediately.

Testimony For:  This bill allows an additional year for the implementation of federal requirements to take effect that replace identical state requirements.  It is important to have in place nationally a single uniform set of identification requirements for the distribution of drugs in interstate commerce, and state requirements should be deferred to allow for this.  Drug manufacturers would otherwise be required to meet a variety of disparate state requirements.

Testimony Against:  It is important for the state to concern itself with the public safety of its residents.  Deferring state requirements for another year leaves people vulnerable to the risks of drug poisoning.

Witnesses:  Don Williams, Board of Pharmacy (con); and Jerald Farley (pro).