[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR207.20]

[Page 104-105]
 
                        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.

[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 
59157, Nov. 27, 2001]

    Effective Date Note: At 66 FR 5466, Jan. 19, 2001, Sec. 207.20 was 
amended by adding paragraph (f), effective Apr. 4, 2003. For the 
convenience of the user, the added text is set forth as follows:

[[Page 105]]

Sec. 207.20  Who must register and submit a drug list?

                                * * * * *

    (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 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.