[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR207.20]

[Page 121-122]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 207_REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN 
COMMERCIAL DISTRIBUTION--Table of Contents
 
          Subpart C_Procedures for Domestic Drug Establishments
 
Sec.  207.20  Who must register and submit a drug list.


    (a) Owners or operators of all drug establishments, not exempt under 
section 510(g) of the act or subpart B of this part 207, that engage in 
the manufacture, preparation, propagation, compounding, or processing of 
a drug or drugs shall register and submit a list of every drug in 
commercial distribution (except that registration and listing 
information may be submitted by the parent, subsidiary, and/or affiliate 
company for all establishments when operations are conducted at more 
than one establishment and there exists joint ownership and control 
among all the establishments). Drug listing is not required for the 
manufacturing, preparation, propagation, compounding, or processing of 
an animal feed bearing or containing an animal drug (i.e., a Type B or 
Type C medicated feed), nor is drug listing required for establishments 
engaged in drug product salvaging. Drug products manufactured, prepared, 
propagated, compounded, or processed in any State as defined in section 
201(a)(1) of the act must be listed whether or not the output of such 
establishments or any particular drug so listed enters interstate 
commerce. No owner or operator may register an establishment if any part 
of the establishment is registered by any other owner or operator.
    (b) Owners or operators of establishments not otherwise required to 
register under section 510 of the act that distribute under their own 
label or trade name a drug manufactured or processed by a registered 
establishment may elect to submit listing information directly to FDA 
and to obtain a Labeler Code. A distributor who submits drug listing 
information shall include the registration number of the drug 
establishment that manufactured, prepared, propagated, compounded, or 
processed each drug listed. All distributors who submit drug listing 
information to FDA assume full responsibility for compliance with all of 
the requirements of this part. Each such distributor at the time of 
submitting or updating drug listing information as required under Sec.  
207.30 shall certify to the registered establishment that the submission 
has been made by providing a signed copy of Form FDA-2656 (Registration 
of Drug Establishment) to the registered establishment that manufactures 
or processes the drug. Each such distributor shall submit the original 
of Form FDA-2656 showing this certification to FDA, and shall accompany 
the certification with a list showing the National Drug Code number that 
the distributor has assigned to each drug product. If a distributor does 
not elect to submit drug listing information directly to FDA and to 
obtain a Labeler Code, the registered establishment shall submit the 
drug listing information. Distributors or registered establishments 
shall use Form FDA-2658 (Registered Establishments' Report of Private 
Label Distributors) to submit drug listing information or to request a 
Labeler Code, or both.
    (c) Before beginning manufacture or processing of a drug subject to 
one of the following applications, an owner or operator of an 
establishment is required to register before the agency approves it: A 
new drug application, an abbreviated new drug application, a new animal 
drug application, an abbreviated new animal drug application, a 
medicated feed mill license application, or a biologics license 
application.
    (d) No registration fee is required.
    (e) Registration and listing do not constitute an admission, or 
agreement, or determination that a product is a drug as defined in 
section 201(g) of the act.
    (f) Owners and operators of establishments or persons engaged in the 
recovery, screening, testing, processing, storage, or distribution of 
human cells, tissues, and cellular and tissue-based products, as defined 
in Sec.  1271.3(d) of this chapter, that are regulated under section 351 
of the Public Health Service Act and/or the Federal Food, Drug, and 
Cosmetic Act must register and list those human cells, tissues, and 
cellular

[[Page 122]]

and tissue-based products with the Center for Biologics Evaluation and 
Research on Form FDA 3356 following the procedures set out in subpart B 
of part 1271 of this chapter, instead of the procedures for registration 
and listing contained in this part, except that the additional listing 
information requirements in Sec.  207.31 remain applicable.

[45 FR 38043, June 6, 1980, as amended at 45 FR 32293, May 16, 1980; 52 
FR 2682, Jan. 26, 1987; 55 FR 11576, Mar. 29, 1990; 64 FR 400, Jan. 5, 
1999; 64 FR 56448, Oct. 20, 1999; 64 FR 63203, Nov. 19, 1999; 66 FR 
5466, Jan. 19, 2001; 66 FR 59157, Nov. 27, 2001; 66 FR 5447, Jan. 19, 
2001]