Washington Administrative Code (Last Updated: November 23, 2016) |
Title 246. Health, Department of |
Chapter 246-895. Pharmacy—Good manufacturing practice for finished pharmaceuticals. |
Section 246-895-170. Variance and procedure.
Latest version.
- Licensees may request that the board issue a variance from specific requirements of WAC 246-895-040 through 246-895-160. The request must be in writing and must explain why the criteria should not apply and how the public's safety would be protected. Issuance of a variance shall be based on the information supplied by the manufacturer requesting the variance, as well as any other information available as a result of any investigation by the board and/or any other relevant information available. After due consideration of all the information, the board may issue or deny the requested variance. Any variance granted shall be limited to the particular case described in the request and shall be posted at the manufacturing location during the time it is in effect. Variances will be reviewed at least every three years. Variances shall be subject to withdrawal or modification at any time if the board finds the variance has resulted in actual or potential harm to the public.[Statutory Authority: RCW 18.64.005. WSR 92-12-035 (Order 277B), § 246-895-170, filed 5/28/92, effective 6/28/92. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. WSR 91-18-057 (Order 191B), recodified as § 246-895-170, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005. WSR 88-21-025 (Order 220), § 360-46-160, filed 10/10/88.]
RCW 18.64.005. WSR 92-12-035 (Order 277B), § 246-895-170, filed 5/28/92, effective 6/28/92. Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW. WSR 91-18-057 (Order 191B), recodified as § 246-895-170, filed 8/30/91, effective 9/30/91. Statutory Authority: RCW 18.64.005. WSR 88-21-025 (Order 220), § 360-46-160, filed 10/10/88.
Rules
246-895-040,246-895-160,