Chapter 16-42 WAC

Last Update: 6/18/08

BIOLOGICAL PRODUCTS

WAC Sections

16-42-005Definitions.
16-42-015License.
16-42-017Permits required.
16-42-023Sale of licensed products.
16-42-026Restricted products.
16-42-035Reports.
DISPOSITION OF SECTIONS FORMERLY CODIFIED IN THIS TITLE
16-42-001Promulgation. [Order 578, Promulgation, effective 5/15/50.] Repealed by Order 896, effective 11/24/62.
16-42-00101Promulgation. [Order 896, Promulgation, effective 11/24/62.] Repealed by WSR 85-15-024 (Order 1866), filed 7/10/85. Statutory Authority: Chapter 16.36 RCW.
16-42-002Promulgation. [Order 767, Promulgation, effective 12/30/57.] Repealed by Order 896, effective 11/24/62.
16-42-010License. [Order 767, Regulation 1, effective 12/30/57.] Repealed by Order 896, effective 11/24/62.
16-42-01001Definition. [Order 896, Regulation 1, effective 11/24/62.] Repealed by WSR 85-15-024 (Order 1866), filed 7/10/85. Statutory Authority: Chapter 16.36 RCW.
16-42-020Who administers. [Order 578, Regulation 2, effective 5/15/50.] Repealed by Order 896, effective 11/24/62.
16-42-02001Vaccine outlets restricted. [Order 896, Regulation 3, effective 11/24/62.] Repealed by WSR 85-15-024 (Order 1866), filed 7/10/85. Statutory Authority: Chapter 16.36 RCW.
16-42-022Biologics. [Statutory Authority: Chapter 16.36 RCW. WSR 85-15-024 (Order 1866), § 16-42-022, filed 7/10/85.] Repealed by WSR 00-17-072, filed 8/14/00, effective 9/14/00. Statutory Authority: RCW 16.36.040.
16-42-025Purchasing and administering biologics limited. [Statutory Authority: Chapter 16.36 RCW. WSR 85-15-024 (Order 1866), § 16-42-025, filed 7/10/85; Order 896, Regulation 4, effective 11/24/62.] Repealed by WSR 00-17-072, filed 8/14/00, effective 9/14/00. Statutory Authority: RCW 16.36.040.
16-42-030Permit. [Order 578, Regulation 3, effective 5/15/50.] Repealed by Order 896, effective 11/24/62.
16-42-03001Exempt vaccines. [Order 896, Regulation 5, filed 11/24/62.] Repealed by WSR 85-15-024 (Order 1866), filed 7/10/85. Statutory Authority: Chapter 16.36 RCW.
16-42-040Report. [Order 578, Regulation 4, effective 5/15/50.] Repealed by Order 896, effective 11/24/62.
16-42-04001Reports of disease outbreak by user. [Order 896, Regulation 7, effective 11/24/62.] Repealed by WSR 85-15-024 (Order 1866), filed 7/10/85. Statutory Authority: Chapter 16.36 RCW.
16-42-045Order is exclusive—Control of sales, etc. [Order 896, Regulation 8, effective 11/24/62.] Repealed by WSR 85-15-024 (Order 1866), filed 7/10/85. Statutory Authority: Chapter 16.36 RCW.
16-42-050Penalty. [Order 578, Penalty, effective 5/15/50.] Repealed by Order 896, effective 11/24/62.
16-42-05001Penalty. [Order 896, Regulation 9, effective 11/24/62.] Repealed by WSR 85-15-024 (Order 1866), filed 7/10/85. Statutory Authority: Chapter 16.36 RCW.
16-42-060Penalty. [Statutory Authority: Chapter 16.36 RCW. WSR 85-15-024 (Order 1866), § 16-42-060, filed 7/10/85.] Repealed by WSR 00-17-072, filed 8/14/00, effective 9/14/00. Statutory Authority: RCW 16.36.040.


16-42-005
Definitions.

"Department" means the Washington state department of agriculture (WSDA).
"Director" means the director of WSDA or the director's authorized representative.
"Veterinary biologic" means any virus, serum, toxin, and analogous product of natural or synthetic origin, or product prepared from any type of genetic engineering, such as diagnostics, antitoxins, vaccines, live microorganisms, killed microorganisms, and the antigenic or immunizing components intended for use in the diagnosis, treatment, or prevention of diseases in animals.
[Statutory Authority: RCW 16.36.040 and chapter 34.05 RCW. WSR 08-13-103, § 16-42-005, filed 6/18/08, effective 7/19/08. Statutory Authority: RCW 16.36.040. WSR 00-17-072, § 16-42-005, filed 8/14/00, effective 9/14/00. Statutory Authority: Chapter 16.36 RCW. WSR 85-15-024 (Order 1866), § 16-42-005, filed 7/10/85.]



16-42-015
License.

Only veterinary biologics that have been produced under a U.S. Veterinary Biological Product License may be imported into the state of Washington. The director may allow the importation of unlicensed veterinary biologics under special use permits.
[Statutory Authority: RCW 16.36.040 and chapter 34.05 RCW. WSR 08-13-103, § 16-42-015, filed 6/18/08, effective 7/19/08. Statutory Authority: Chapter 16.36 RCW. WSR 85-15-024 (Order 1866), § 16-42-015, filed 7/10/85; Order 896, Regulation 2, effective 11/24/62.]



16-42-017
Permits required.

(1) Any person manufacturing veterinary biologics within the state for distribution within the state must first obtain a permit from the director. This permit may be revoked or suspended under chapter 34.05 RCW for any violation of this chapter.
(2) Written approval of the director is required before any newly licensed veterinary biologic is imported into the state for sale, use or distribution. The director may also require a special permit for the importation or distribution of prelicensed veterinary biologics into Washington state.
[Statutory Authority: RCW 16.36.040 and chapter 34.05 RCW. WSR 08-13-103, § 16-42-017, filed 6/18/08, effective 7/19/08. Statutory Authority: RCW 16.36.040. WSR 00-17-072, § 16-42-017, filed 8/14/00, effective 9/14/00. Statutory Authority: Chapter 16.36 RCW. WSR 85-15-024 (Order 1866), § 16-42-017, filed 7/10/85.]



16-42-023
Sale of licensed products.

Veterinary biologics produced in accordance with WAC 16-42-015 or 16-42-017 may be sold over the counter as well as by persons or firms properly licensed under chapter 18.64 RCW and by any veterinarian licensed under chapter 18.92 RCW. Persons other than licensed veterinarians or state or federal veterinarians may purchase and administer veterinary biologics to their own animals, except for those veterinary biologics restricted in WAC 16-42-026.
[Statutory Authority: RCW 16.36.040 and chapter 34.05 RCW. WSR 08-13-103, § 16-42-023, filed 6/18/08, effective 7/19/08. Statutory Authority: RCW 16.36.040. WSR 00-17-072, § 16-42-023, filed 8/14/00, effective 9/14/00.]



16-42-026
Restricted products.

(1) All veterinary biologics now in existence or newly developed to diagnose, prevent, or combat the following diseases are declared by the director to be of such a nature that their control is necessary to protect animal health:
(a) Avian influenza.
(b) Anthrax.
(c) Bluetongue.
(d) Brucellosis.
(e) Equine infectious anemia.
(f) Equine viral arteritis.
(g) Paratuberculosis.
(h) Pseudorabies.
(i) Rabies.
(j) Tuberculosis.
(k) Foot and mouth.
(l) Vesicular stomatitis.
(m) All conditionally approved vaccines.
(2) All veterinary biologics used to control or diagnose any of the diseases listed in subsection (1) of this section are restricted, and may only be purchased, administered, or otherwise used by or under the direct supervision of veterinarians licensed under chapter 18.92 RCW, or by state or federal veterinarians. The director may authorize others by written permit to purchase the veterinary biologics listed in subsection (1) of this section for research agencies or laboratories authorized by the department, for emergency disease control programs, or for other limited and controlled purposes.
[Statutory Authority: RCW 16.36.040 and chapter 34.05 RCW. WSR 08-13-103, § 16-42-026, filed 6/18/08, effective 7/19/08. Statutory Authority: RCW 16.36.040. WSR 00-17-072, § 16-42-026, filed 8/14/00, effective 9/14/00.]



16-42-035
Reports.

In the interest of public health and good cooperative disease control it is recommended that any person using any veterinary biologics immediately report to the department any suspected or actual disease outbreak that occurs in connection with use of the veterinary biologic.
[Statutory Authority: RCW 16.36.040 and chapter 34.05 RCW. WSR 08-13-103, § 16-42-035, filed 6/18/08, effective 7/19/08. Statutory Authority: RCW 16.36.040. WSR 00-17-072, § 16-42-035, filed 8/14/00, effective 9/14/00. Statutory Authority: Chapter 16.36 RCW. WSR 85-15-024 (Order 1866), § 16-42-035, filed 7/10/85; Order 896, Regulation 6, effective 11/24/62.]