[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: 21CFR206.7]

[Page 100]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 206--IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE--Table of Contents
 
Sec. 206.7  Exemptions.

    (a) The following classes of drug products are exempt from 
requirements of this part:
    (1) Drug products intended for use in a clinical investigation under 
section 505(i) of the act, but not including drugs distributed under a 
treatment IND under part 312 of this chapter or distributed as part of a 
nonconcurrently controlled study. Placebos intended for use in a 
clinical investigation are exempt from the requirements of this part if 
they are designed to copy the active drug products used in that 
investigation.
    (2) Drugs, other than reference listed drugs, intended for use in 
bioequivalence studies.
    (3) Drugs that are extemporaneously compounded by a licensed 
pharmacist, upon receipt of a valid prescription for an individual 
patient from a practitioner licensed by law to prescribe or administer 
drugs, to be used solely by the patient for whom they are prescribed.
    (4) Radiopharmaceutical drug products.
    (b) Exemption of drugs because of size or unique physical 
characteristics:
    (1) For a drug subject to premarket approval, FDA may provide an 
exemption from the requirements of Sec. 206.10 upon a showing that the 
product's size, shape, texture, or other physical characteristics make 
imprinting technologically infeasible or impossible.
    (i) Exemption requests for products with approved applications shall 
be made in writing to the appropriate review division in the Center for 
Drug Evaluation and Research (CDER) or the Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857. If FDA denies the request, the holder 
of the approved application will have 1 year after the date of an agency 
denial to imprint the drug product.
    (ii) Exemption requests for products that have not yet received 
approval shall be made in writing to the appropriate review division in 
CDER or CBER.
    (2) Any product not subject to premarket approval is exempt from the 
requirement of Sec. 206.10 if, based on the product's size, shape, 
texture, or other physical characteristics, the manufacturer or 
distributor of the product is prepared to demonstrate that imprinting 
the dosage form is technologically infeasible or impossible.
    (c) For drugs that are administered solely in controlled health care 
settings and not provided to patients for self-administration, sponsors 
may submit requests for exemptions from the requirements of this rule. 
Controlled settings include physicians' offices and other health care 
facilities. Exemption requests should be submitted in writing to the 
appropriate review division in CDER or CBER.