[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.1001]
[Page 356]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 73_LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table
of Contents
Subpart B_Drugs
Sec. 73.1001 Diluents in color additive mixtures for drug use exempt
from certification.
The following diluents may be safely used in color additive mixtures
that are exempt from certification and which are to be used for coloring
drugs, subject to the condition that each straight color in the mixture
has been exempted from certification or, if not so exempted, is from a
batch that has previously been certified and has not changed in
composition since certification. Such listing of diluents is not to be
construed as superseding any of the other requirements of the Federal
Food, Drug, and Cosmetic Act with respect to drugs, including new drugs.
If a definition and specification for a particular diluent is not set
forth in this subpart, the material shall be of a purity consistent with
its intended use.
(a) Ingested drugs--(1) General use. Diluents listed in Sec.
73.1(a) and the following:
------------------------------------------------------------------------
Definitions and
Substances specifications Restrictions
------------------------------------------------------------------------
Alcohol, specially denatured.. As set forth in 26 As set forth in 26
CFR, pt. 212. CFR, pt. 211.
Cetyl alcohol................. As set forth in
N.F. XI.
Isopropyl alcohol............. ................... In color coatings
for pharmaceutical
forms, no residue.
Polyoxyethylene (20) sorbitan As set forth in
monostearate (Polysorbate 60). sec. 172.836 of
this chapter.
Polyoxyethylene (20) sorbitan As set forth in
tristearate (Polysorbate 65). sec. 172.838 of
this chapter.
Polysorbate 80................ As set forth in
sec. 172.840 of
this chapter.
Polyvinyl-pyrrolidone......... As set forth in
sec. 173.55 of
this chapter.
Sorbitan monooleate...........
Sorbitan monostearate......... As set forth in
sec. 172.842 of
this chapter.
Sorbitan trioleate............
------------------------------------------------------------------------
(2) Special use; inks for branding pharmaceutical forms. Items
listed in paragraph (a)(1) of this section, Sec. 73.1(b)(1)(i), and the
following:
Ethyl lactate
Polyoxyethylene sorbitan monolaurate (20)
(b) Externally applied drugs. Diluents listed in paragraph (a)(1) of
this section and the following:
------------------------------------------------------------------------
Definitions and
Substances specifications
------------------------------------------------------------------------
Benzyl alcohol........................... As set forth in N.F. XI.
Ethyl cellulose.......................... As set forth in Sec.
172.868 of this chapter.
Hydroxyethyl cellulose...................
Hydroxypropyl cellulose.................. As set forth in Sec.
172.870 of this chapter.
------------------------------------------------------------------------
Additives that reference this regulation: |
