[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.48]

[Page 143]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 211_CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
                   Subpart C_Buildings and Facilities
 
Sec.  211.48  Plumbing.

    (a) Potable water shall be supplied under continuous positive 
pressure in a plumbing system free of defects that could contribute 
contamination to any drug product. Potable water shall meet the 
standards prescribed in the Environmental Protection Agency's Primary 
Drinking Water Regulations set forth in 40 CFR part 141. Water not 
meeting such standards shall not be permitted in the potable water 
system.
    (b) Drains shall be of adequate size and, where connected directly 
to a sewer, shall be provided with an air break or other mechanical 
device to prevent back-siphonage.

[43 FR 45077, Sept. 29, 1978, as amended at 48 FR 11426, Mar. 18, 1983]

    Effective Date Note: At 72 FR 68068, Dec. 4, 2007, Sec.  211.48 was 
amended by revising paragraph (a), effective Apr. 17, 2008. For the 
convenience of the user, the revised text is set forth as follows:


 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 211_CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
                   Subpart C_Buildings and Facilities
 
Sec.  211.48  Plumbing.

    (a) Water supplied by the plumbing system of the facility must be 
safe for human consumption. This water shall be supplied under 
continuous positive pressure in a plumbing system free of defects that 
could contribute contamination to any drug product.

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