Persius/hicric huggingface dataset:
CPG Sec. 450.100 CGMP Enforcement Policy - OTC vs Rx Drugs  
BACKGROUND: 
Because of increased visibility and promotion of certain OTC preparations, there are periodic inquiries 
from division offices within the Office of Pharmaceutical Quality Operations (OPQO) regarding whether 
or not the enforcement policy for CGMP regulations is the same for OTC drug products as it is for 
prescription (Rx) drug products. 
Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act requires drugs to be manufactured in 
conformance with current good manufacturing practice. This section does not differentiate between 
OTC and Rx products and it was not intended by Congress to do so. 
A prescription drug may be toxic or have other potential for harm, which requires that it be 
administered only under the supervision of a licensed practitioner (section 503(b)(1) of the Act). For this 
reason, problems associated with its manufacture are generally more likely to cause serious problems. 
POLICY: 
The CGMP regulations apply to all drug products, whether OTC or prescription. 
REGULATORY GUIDANCE: 
The selection of an enforcement action to be applied will be based on the seriousness of the deviation, 
including such factors as potential hazard to the consumer. 
Issued: 4/1/82
A- 
s m w a s  
D E P m m E N x w H  EAL-m & HUMAN 
Public Health Service 
Food and Orug Administratioi 
SEP 16: 1981  Rockville MD 20857 
TO:  Manufacturers  and Potential Manufacturers of  Sunlamp Products 
(Including Tanning Booths) 
. 
SU. BSECT:  Exmptian ran Reporting and Recordkeeping  ts for 
Certain Sunlamp Product Manufacturers 
BACKGROUND:  The regulations in 21 CFR 1002 pranulgated under the 
Radiation Control for Health and Safety Act of  1968 require, amng other 
things,  that a manufacturer  of an electronic product subject to a 
performance  standard sutxnit an initial report, annual reports,  and model 
change reports, as applicable,  to the Director,  Bureau of  Radiological 
. 
.lo, 
Health (21 CFR 1002  1002. ll and  1002-12)  Fmthermre, a manufacturer  , 
of  an electronic product subject to a perfomce standard is required 
to mint-  certain records including a description of  the quality 
control procedures with respect to the prcduct's radiation safety, results 
of  life testing and capies of  written camnications between the manufacturer, 
dealers, distributors and purchasers regarding radiation safety (21 CFR 
1002.30 (a) 1 and preserve such records for a period  of  5 years ran the date 
of  the record (21 CFR 1002.31(a)), 
The Bureau's experience in the e n f o r m t  of  the performance  standard 
for sunlamp prducts (21 CE'R  1040.20)  indicates that the above referenced 
reporting and recordkeeping requirertrtnts seem to be  an overburden for an 
individual or fhw ho  manufactures on a one time or infrequent basis a 
small nunher of  sunlamp products  (usually less than 10) for his awn use. 
FSrapthg this type of marmfacturer ran the referenced reporting and 
recordkeeping requirerrrents under certain conditions would not carrpranise 
the spirit or purpose of  the Act since FDA can determine cqliance 
through product inspections. 
EXEWTICkJ:  Any person who  manufactures less than 10 sunlamp products for 
use in their am carnercial suntanning facilities is hereby exempted 
under the authority of  21CFR 1002.50  ran the requirements of  21 CFR 
1002.10,  1002.11,  1002.12,  1002-30 and 1002.31 provided  that such person 
notifies the Director,  Division of  Capliance, that less than 10 sunlamp 
products are being manufactured for the use of  that person and provides 
the Director with the name and address of  the manufacturing location. 
4 
Persans who wish to manufacture mre than 10 sunlmp products for use in 
their own -cia1  sunLLanning facilities are not included in this 
exerrrptian but my IMke a written application for exemption to the Director, 
Bureau of Radiological Health, in accordance with 21 CFR  1002.50  stating 
the ncanber of  products they intend to manufacture and over what period 
of  time manufacturing w i l l  occur. 
/  / 
Bureau of  Radiological Health 
i
CPG Sec. 555.450 Foods - Adulteration 
Involving Infestation and 1080 Rodenticide 
REGULATORY ACTION GUIDANCE: 
The following represents the criteria for direct citation by ORA Field Offices: 
1.  Infestation: Inspection shows substantial insect, rodent, or bird infestation of an 
establishment manufacturing or storing food for human use, with direct avenues of 
contamination, with or without filth findings in correlated samples. 
2.  1080 Rodenticide: Inspection shows careless use of 1080 in an establishment 
manufacturing or storing food for human or animal use. 
Issued: 10/1/80
CPG Sec. 555.500 All Food Sanitation 
(Including Bacteriological) Inspections - 
Classification of Establishment 
POLICY: 
Firm must have finished product or raw material in IS status. 
REGULATORY ACTION GUIDANCE: 
The following represents the criteria for the classification of an establishment as OAI. 
1.  If specific guides (i.e., smoked fish) exist in the foods sanitation area, call actionable if 
guide criteria met. Otherwise not actionable unless findings meet one or more criteria 
below. 
2.  Use of raw materials that are actionable as received under existing guide if EIR shows 
raw materials not cleaned or sorted before use to bring raw materials below guide figures. 
3.  Finished product examinations show it to be actionable under existing guides. 
4.  Live insects in establishment in such locations as to be a good possibility that raw 
materials, in process material, finished product, or stored food may have become 
contaminated by insects. (Probable avenues of contamination must be shown). 
5.  Fresh rodent or bird evidence in establishment in such locations as to be a good 
possibility that raw materials, in process materials, finished product or stored food may 
have become contaminated by rodent or birds. (Probable avenues of contamination must 
be shown). 
6.  EIR shows that food contact surfaces in use on day (or days) of inspection were not 
adequately cleaned before (or after) days operations and visible residues remain on such 
surfaces. 
7.  Glass breakage resulting in likely product contamination unless plant procedures are 
sufficient to insure removal of glass from food. 
8.  This guide obviously does not cover all actionable situations and if other situations occur 
that appear actionable the EIR should be forwarded to appropriate ORA Program 
Division Director with a specific recommendation for action.  
Issued: 10/1/80
CPG Sec. 578.400 Treated Grain Seed - 
Mercury Residue 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for direct reference seizure *requests to the Office of Human 
and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and 
Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office 
within the Human and Animal Food Program*: 
The wheat contains an average of 10 or more pink kernels per 500 grams, and the mercury 
residue on the pink kernels exceeds one part per million. 
SPECIMEN CHARGE: 
Article adulterated when introduced into and while in interstate commerce, within meaning of 21 
U.S.C. 342(a)(2)(B), in that it is a raw agricultural commodity and contains a pesticide chemical, 
namely, a mercurial compound, which is unsafe within meaning of 21 U.S.C. 346a(a), since no 
tolerance and no exemption from the requirement of a tolerance for such pesticide chemical on 
wheat has been prescribed by regulations promulgated pursuant to 21 U.S.C. 346a(b). 
Issued: 10/1/80
Compliance Policy Guide 
Sec. 390.100 Definition of "Commerce" - 21 CFR 1000.3(d) 
 
Guidance for FDA Staff 
 
This document supersedes Sec. 390.100 Definition of Commerce  21 CFR  
1000.3(d) previously revised on 03/2005. 
  
 
  
Issued by: 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
10/1980 
 
This guidance represents the Food and Drug Administration's (FDA's)  current 
thinking on  this topic. It does not create or confer any rights for or on  any person  
and does not operate to bind FDA or the public. You can use an alternative 
approach if the approach satisfies the requirements of the applicable statutes and 
regulations. If you want to discuss an alternative approach, contact the FDA staff 
responsible for implementing  this guidance. If  you cannot  identify the appropriate 
FDA staff, call the telephone number listed on the title page of this guidance. 
 
 
I. Introduction: 
 
This document is intended for FDA staff, regulated manufacturers, and the general 
public. This document clarifies the legal status  of an individual who manufactures an  
electronic product solely for his own use in  his own commercial activities.  
  
FDA's guidance documents, including this guidance, do not establish legally  
enforceable responsibilities. Instead, guidances describe the Agency's current 
thinking on  a topic and should be viewed only as recommendations, unless specific  
regulatory or statutory requirements are cited. The use of the word should in Agency 
guidances means that something is suggested or recommended, but not required.  
 
II. Background: 
 
Section 538(a)(1) of the Federal Food, Drug, and Cosmetic Act, Subchapter C-
Electronic Product Radiation Control prohibits the introduction into commerce of any  
electronic product which does not conform to  an applicable standard.  
 
Questions have been raised as to whether a person who manufactures an electronic 
product, for which a standard has been prescribed, for use solely in his own 
commercial activities or manufacturing process, has introduced the product into 
commerce. 
  III Policy: 
 
Such a person would not have introduced the product into  commerce within the 

meaning of Section 538(a)(1). However, Section 538(a)(5) of the Act makes it a 

prohibited act for any person to  fail to issue a certification as required by Section 
 
534(h), regardless of whether the electronic product in question has itself been 

physically introduced into commerce. The assembly and use of an electronic product 

by a person engaged in the business of assembling that product (as defined in 

Section 531(2) for commercial purposes in his own facility affects interstate 

commerce; thus Section 534(h) would require that the manufacturer certify that the 

product conforms to the relevant standard. However, if that person in no way 

receives compensation for the assembly and use of the product, he would not be  

engaged in the business and therefore would not be a manufacturer subject to 

Section 534(h) and 538(a)(5). 

 
Issued: 10/1/80 

Revised: 3/95, 3/2005, 11/2012 (format only)
CDER Bioequivalence Recommendations 
Withdrawn Listing 2014 
 
Title  Type  Route of  Dosage Form  RLD  Date  Date 
Administration  Posted  Withdrawn 
Levonorgestrel   Draft  Intrauterine  Device,  203159  4/2014  10/20/2014 
Intrauterine 
13.5 mg. 
Levonorgestrel  Draft  Intrauterine  Device,  21225  4/2014  10/20/2014 
Intrauterine 
52 mg. 
Nisoldipine  Draft  Oral  Tablet,  20356  10/2011  9/3/2014 
Extended 
Release 
Phenytoin  Draft  Oral  Capsule,  84349    8/22/2014 
sodium   Extended 
Release 
Phenytoin  Draft  Oral  Capsule,  402298    8/22/2014 
sodium  Extended 
Release 
Hydrocodone  Draft  Oral  Tablet  20716  12/2009  8/11/2014 
Bitartrate, 
Ibuprofen 
Eltrombopag  Draft  Oral  Tablet  22291  6/2013  4/16/2014
CPG Sec. 590.300 Direct Reference Authority 
for Pseudomonas Contamination of Cosmetics 
Used in the Eye Area 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for deciding when direct reference seizure *requests to the 
Office of Human and Animal Food Operations (OHAFO) in consultation with the Office of 
Enforcement and Import Operations (OEIO) and CFSAN) is appropriate: 
Any cosmetic product intended for use in the eye area which contains Pseudomonas aeruginosa. 
REMARKS: 
Direct reference seizure recommendations should be accompanied by complete labeling and 
worksheets. Positive identification using the method found in Chapter 25 of the Bacteriological 
Analytical Manual (BAM) is necessary to support the charge. Speciate Pseudomonas isolates 
using biochemical tests (BAM, Chapter 25) or appropriate commercial identification kits. 
SPECIMEN CHARGE: 
The article (was adulterated when introduced into and while in interstate commerce) (is 
adulterated while held for sale after shipment in interstate commerce) within the meaning of the 
Act, 21 U.S.C. 361(a), in that it contains a poisonous or deleterious substance, Pseudomonas 
aeruginosa, which may render it injurious to users under such conditions of use as are customary 
or usual. 
*Material between asterisks is new or revised.* 
Issued: 4/10/91 
Revised: 8/96, 5/2005 
Updated: 11/29/05