[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR111.70]

[Page 237-238]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 111_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS--Table of Contents
 
  Subpart E_Requirement to Establish a Production and Process Control 
                                 System
 
Sec.  111.70  What specifications must you establish?

    (a) You must establish a specification for any point, step, or stage 
in the manufacturing process where control is necessary to ensure the 
quality of the dietary supplement and that the dietary supplement is 
packaged and labeled as specified in the master manufacturing record.
    (b) For each component that you use in the manufacture of a dietary 
supplement, you must establish component specifications as follows:
    (1) You must establish an identity specification;
    (2) You must establish component specifications that are necessary 
to ensure that specifications for the purity, strength and composition 
of dietary supplements manufactured using the components are met; and
    (3) You must establish limits on those types of contamination that 
may adulterate or may lead to adulteration of the finished batch of the 
dietary supplement to ensure the quality of the dietary supplement.
    (c) For the in-process production:
    (1) You must establish in-process specifications for any point, 
step, or stage in the master manufacturing record where control is 
necessary to help ensure that specifications are met for the identity, 
purity, strength, and composition of the dietary supplements and, as 
necessary, for limits on those types of contamination that may 
adulterate or may lead to adulteration of the finished batch of the 
dietary supplement;
    (2) You must provide adequate documentation of your basis for why 
meeting the in-process specifications, in combination with meeting 
component specifications, will help ensure that the specifications are 
met for the identity,

[[Page 238]]

purity, strength, and composition of the dietary supplements and for 
limits on those types of contamination that may adulterate or may lead 
to adulteration of the finished batch of the dietary supplement; and
    (3) Quality control personnel must review and approve the 
documentation that you provide under paragraph (c)(2) of this section.
    (d) You must establish specifications for dietary supplement labels 
(label specifications) and for packaging that may come in contact with 
dietary supplements (packaging specifications). Packaging that may come 
into contact with dietary supplements must be safe and suitable for its 
intended use and must not be reactive or absorptive or otherwise affect 
the safety or quality of the dietary supplement.
    (e) For each dietary supplement that you manufacture you must 
establish product specifications for the identity, purity, strength, and 
composition of the finished batch of the dietary supplement, and for 
limits on those types of contamination that may adulterate, or that may 
lead to adulteration of, the finished batch of the dietary supplement to 
ensure the quality of the dietary supplement.
    (f) If you receive a product from a supplier for packaging or 
labeling as a dietary supplement (and for distribution rather than for 
return to the supplier), you must establish specifications to provide 
sufficient assurance that the product you receive is adequately 
identified and is consistent with your purchase order.
    (g) You must establish specifications for the packaging and labeling 
of the finished packaged and labeled dietary supplements, including 
specifications that ensure that you used the specified packaging and 
that you applied the specified label.