[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.176]

[Page 131]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
                     Subpart I--Laboratory Controls
 
Sec. 211.176  Penicillin contamination.

    If a reasonable possibility exists that a non-penicillin drug 
product has been exposed to cross-contamination with penicillin, the 
non-penicillin drug product shall be tested for the presence of 
penicillin. Such drug product shall not be marketed if detectable levels 
are found when tested according to procedures specified in `Procedures 
for Detecting and Measuring Penicillin Contamination in Drugs,' which is 
incorporated by reference. Copies are available from the Division of 
Research and Testing (HFD-470), Center for Drug Evaluation and Research, 
Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.

[43 FR 45077, Sept. 29, 1978, as amended at 47 FR 9396, Mar. 5, 1982; 50 
FR 8996, Mar. 6, 1985; 55 FR 11577, Mar. 29, 1990]