[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.176]

[Page 150]
 
                        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--
 
                      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, 5100 Paint Branch Pkwy., College Park, MD 
20740, or available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.

[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; 66 FR 56035, Nov. 6, 
2001; 69 FR 18803, Apr. 9, 2004]