[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR111.10]

[Page 230-231]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 111_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS--Table of Contents
 
                           Subpart B_Personnel
 
Sec.  111.10  What requirements apply for preventing microbial contamination from sick or infected personnel and for hygienic practices?

    (a) Preventing microbial contamination. You must take measures to 
exclude from any operations any person who might be a source of 
microbial contamination, due to a health condition, where such 
contamination may occur, of any material, including components, dietary 
supplements, and contact surfaces used in the manufacture, packaging, 
labeling, or holding of a dietary supplement. Such measures include the 
following:
    (1) Excluding from working in any operations that may result in 
contamination any person who, by medical examination, the person's 
acknowledgement, or supervisory observation, is shown to have, or 
appears to have, an illness, infection, open lesion, or any other 
abnormal source of microbial contamination, that could result in 
microbial contamination of components, dietary supplements, or contact 
surfaces, until the health condition no longer exists; and
    (2) Instructing your employees to notify their supervisor(s) if they 
have or if there is a reasonable possibility that they have a health 
condition described in paragraph (a)(1) of this section that could 
result in microbial contamination of any components, dietary 
supplements, or any contact surface.
    (b) Hygienic practices. If you work in an operation during which 
adulteration of the component, dietary supplement, or contact surface 
could occur, you must use hygienic practices to the extent necessary to 
protect against such contamination of components, dietary supplements, 
or contact surfaces. These hygienic practices include the following:
    (1) Wearing outer garments in a manner that protects against the 
contamination of components, dietary supplements, or any contact 
surface;
    (2) Maintaining adequate personal cleanliness;
    (3) Washing hands thoroughly (and sanitizing if necessary to protect 
against contamination with microorganisms) in an adequate hand-washing 
facility:
    (i) Before starting work; and
    (ii) At any time when the hands may have become soiled or 
contaminated;
    (4) Removing all unsecured jewelry and other objects that might fall 
into components, dietary supplements, equipment, or packaging, and 
removing hand jewelry that cannot be adequately sanitized during periods 
in which components or dietary supplements are manipulated by hand. If 
hand jewelry cannot be removed, it must be covered by material that is 
maintained in an intact, clean, and sanitary condition and that 
effectively protects against contamination of components, dietary 
supplements, or contact surfaces;
    (5) Maintaining gloves used in handling components or dietary 
supplements in an intact, clean, and sanitary condition. The gloves must 
be of an impermeable material;
    (6) Wearing, where appropriate, in an effective manner, hair nets, 
caps, beard covers, or other effective hair restraints;
    (7) Not storing clothing or other personal belongings in areas where 
components, dietary supplements, or any contact surfaces are exposed or 
where contact surfaces are washed;
    (8) Not eating food, chewing gum, drinking beverages, or using 
tobacco products in areas where components,

[[Page 231]]

dietary supplements, or any contact surfaces are exposed, or where 
contact surfaces are washed; and
    (9) Taking any other precautions necessary to protect against the 
contamination of components, dietary supplements, or contact surfaces 
with microorganisms, filth, or any other extraneous materials, including 
perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied 
to the skin.