Document Citation: 17 CCR 10377.6

Header:
CALIFORNIA CODE OF REGULATIONS
TITLE 17. PUBLIC HEALTH
DIVISION 1. STATE DEPARTMENT OF HEALTH SERVICES
CHAPTER 5. SANITATION (ENVIRONMENTAL)
SUBCHAPTER 2. FOODS AND DRUGS
GROUP 1. RULES AND REGULATIONS
ARTICLE 2. DRUGS AND DEVICES RE

Date:
08/31/2009

Document:
§ 10377.6. Written Policies and Procedures for the Handling of Human Prescription Drugs

(a) Human prescription drug manufacturers shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the security and disposition of human prescription drugs including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories.

(b) Human prescription drug manufacturers shall include in their written policies and procedures the following:

(1) A procedure to be followed for handling recalls and withdrawals of human prescription drugs. This procedure shall be adequate to deal with recalls and withdrawals due to:

(A) Any action initiated at the request of the Department, the federal Food and Drug Administration or other federal, state, or local law enforcement or other government agency;

(B) Any voluntary action by the manufacturer to remove defective or potentially defective human prescription drugs from the market; or

(C) Any action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design;

(2) A procedure to ensure that the manufacturer is prepared for, protected against, and is ready to handle any crisis that affects security or operation of any facility in the event of fire, flood, or other natural disaster, or strike or other situations of local, state or national emergency; and

(3) A procedure to ensure that any outdated human prescription drugs shall be segregated from other drugs and destroyed. This procedure shall provide for written documentation of the disposition of outdated human prescription drugs. This documentation shall be maintained for at least three years after disposition of the outdated human prescription drugs.