FINAL BILL REPORT

SHB 931

                                  C 411 L 87

BYHouse Committee on Health Care (originally sponsored by Representatives Leonard, Padden, Braddock, Day, Hine, Lewis, Appelwick and Sprenkle)

Regulating the possession and distribution of legend drug samples.

House Committe on Health Care

Senate Committee on Human Services & Corrections

SYNOPSIS AS ENACTED

BACKGROUND:

For marketing purposes, pharmaceutical manufacturers give complimentary sample prescription drugs to physicians and other prescribers.  Distribution of these samples is not regulated.  Manufacturers' representatives who distribute sample controlled substances are not required to register with the Board of Pharmacy.  There have been instances in which sample prescription drugs have been diverted to uses other than the intended use.

SUMMARY:

Pharmaceutical manufacturers that intend to distribute complimentary prescription drug samples must register annually with the Board of Pharmacy.  The manufacturer must provide a 24-hour telephone number and the name of a person who can respond to reasonable board inquiries concerning possible violations of the law, based on reasonable cause.  A manufacturer must respond to a board request for the location of drug storage sites as soon as possible, but no later than the board's close of business on the day following the request.  Records and an inventory of drug samples, available for inspection upon reasonable cause, must be maintained by the manufacturer.  Any loss or theft of drug samples must be reported to the board as soon as possible.  Manufacturers are required to identify the practitioners to whom the sample drugs are distributed and the drugs distributed.  Requirements for storage, transportation and disposal of drug samples are specified.

A civil penalty of up to $5,000 for violations of the act is established.  Sample drugs may be seized after notice is given by the board.  Manufacturers are liable for the acts of their representatives.

All records and reports of the manufacturer obtained by the board are exempt from public disclosure except the identity of persons violating federal and state laws.

The board may charge a reasonable fee for registration, not exceeding a pharmacy location license fee.

VOTES ON FINAL PASSAGE:

      House 96   0

      Senate    47     1(Senate amended)

      House       (House refused to concur)

Conference Committee

      Senate    45     0

      House 96   0

EFFECTIVE:July 26, 1987