[Title 21 CFR C]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED]
[Subchapter B - FOOD FOR HUMAN CONSUMPTION]
[Part 107 - INFANT FORMULA]
[Subpart C - Exempt Infant Formulas]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  2
  1996-04-01
  1996-04-01
  false
  
  C
  Subpart C
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED
    FOOD FOR HUMAN CONSUMPTION
    INFANT FORMULA
  


                    Subpart C--Exempt Infant Formulas



Sec. 107.50  Terms and conditions.

    (a) Terms and conditions. Section 412(f)(1) of the act exempts from 
the requirements of section 412(a), (b), and (c)(1)(A) of the act infant 
formulas that are represented and labeled for use by an infant who has 
an inborn error of metabolism or low brith weight or who otherwise has 
an unusual medical or dietary problem, if such formulas comply with 
regulations prescribed by the Secretary. The regulations in this subpart 
establish the terms and conditions that a manufacturer must meet with 
respect to such infant formulas.
    (b) Infant formulas generally available at the retail level. (1) 
These exempt infant formulas can generally be purchased from retail 
store shelves that are readily available to the public. Such formulas 
are also typically represented and labeled for use to provide dietary 
management for diseases or conditions that are not clinically serious or 
life-threatening, even though such formulas may also be represented and 
labeled for use in clinically serious or life-threatening disorders.
    (2) Except as provided in paragraphs (b)(4) and (5) of this section, 
an infant formula manufacturer shall, with respect to each formula 
covered by this paragraph, comply with the nutrient requirements of 
section 412(g) of the act or of regulations promulgated under section 
412(a)(2) of the act, the quality control procedure requirements of part 
106, and the labeling requirements of subpart B of this part.
    (3) To retain the exempt status of an infant formula covered by this 
paragraph, the manufacturer shall submit to the Food and Drug 
Administration (FDA), at the address specified in paragraph (e)(1) of 
this section, on or before May 21, 1986, or on or before the 90th day 
before the first processing of the infant formula for commercial or 
charitable distribution, whichever occurs later, the label and other 
labeling of the infant formula, a complete quantitative formulation for 
the infant formula, and a detailed description of the medical conditions 
for which the infant formula is represented. FDA will review the 
information under paragraph (d) of this section.
    (4) To retain the exempt status of an infant formula covered by this 
paragraph, when any change in ingredients or processes that may result 
in an adverse impact on levels of nutrients or availability of nutrients 
is instituted, the manufacturer shall submit to FDA at the address 
specified in paragraph (e)(1) of this section, before the first 
processing of the infant formula, the label and other labeling of the 
infant formula, a complete quantitative formulation for the infant 
formula, a detailed description of the reformulation and the rationale 
for the reformulation, a complete description of the change in 
processing, and a detailed description of the medical conditions for 
which the infant formula is represented. FDA will review that 
information under paragraph (d) of this section.
    (5) A manufacturer may deviate from the requirements of paragraph 
(b)(2) of this section only with respect to those specific requirements 
for which it submits to FDA, at the address specified in paragraph 
(e)(1) of this section, the medical, nutritional, scientific, or 
technological rationale (including any appropriate animal or human 
clinical studies). FDA will review that information under paragraph (d) 
of this section.
    (c) Infant formulas not generally available at the retail level. (1) 
These exempt infant formulas are not generally found on retail shelves 
for general consumer purchase. Such formulas typically are prescribed by 
a physician, and must be requested from a pharmacist or are distributed 
directly to institutions such as hospitals, clinics, and State or 
Federal agencies. Such formulas are also generally represented and 
labeled solely to provide dietary management for specific diseases or 
conditions that are

[[Page 185]]

clinically serious or life-threatening and generally are required for 
prolonged periods of time. Exempt infant formulas distributed directly 
to institutions such as hospitals, clinics, and State or Federal 
agencies that are of the same formulation as those generally available 
at the retail level are subject to the requirements of paragraph (b) of 
this section rather than to the requirements of this paragraph.
    (2) Except as provided for in paragraph (c)(5) of this section, an 
infant formula manufacturer shall, with respect to each formula covered 
by this paragraph, comply with the nutrient requirements of section 
412(g) of the act or of regulations promulgated under section 412(a)(2) 
of the act, and the labeling requirements of subpart B of this part.
    (3) Each manufacturer of an infant formula covered by this paragraph 
shall establish quality control procedures designed to ensure that the 
infant formula meets applicable nutrient requirements of this section, 
including any special nutritional characteristics for the specific 
disorders or conditions for which the formula is represented for use. 
Each manufacturer shall maintain records of such quality control 
procedures sufficient to permit a public health evaluation of each 
manufactured batch of infant formula and shall permit any authorized FDA 
employee at all reasonable times to have access to and to copy and 
verify the records referred to in this paragraph.
    (4) To retain the exempt status of an infant formula covered by this 
paragraph, the manufacturer shall submit the information required by 
paragraphs (b)(3) and (4) of this section.
    (5) A manufacturer may deviate from the requirements of paragraph 
(c)(2) of this section only with respect to those specific requirements 
for which it submits to FDA, at the address specified in paragraph 
(e)(1) of this section, the medical, nutritional, scientific, or 
technological rationale (including any appropriate animal or human 
clinical studies). FDA will review that information under paragaraph (d) 
of this section.
    (6) The requirements of this section do not apply to an infant 
formula specially and individually prepared for one or more specific 
infants on a physician's request.
    (d) FDA review of exempt status. (1) FDA's Center for Food Safety 
and Applied Nutrition will review information submitted by infant 
formula manufacturers under paragraph (b) (3), (b) (4), or (c) (4) of 
this section. On the basis of such review and other information 
available to the agency, the Center for Food Safety and Applied 
Nutrition may impose additional conditions on, or modify requirements 
for, the quality control procedures, nutrient specifications, or 
labeling of an infant formula, or withdraw a product's exempt status. 
Such determinations will be made by the Director of the Center for Food 
Safety and Applied Nutrition.
    (2)(i) If after completing its review of all information submitted, 
the Center for Food Safety and Applied Nutrition concludes that 
additional or modified quality control, nutrient, or labeling 
requirements are needed, or that a product's exempt status is withdrawn, 
the Center for Food Safety and Applied Nutrition will so notify the 
manufacturer and this notification will specify the reasons therefor. 
Upon receipt of this notification, the manufacturer has 10 working days 
to have the decision reviewed under Sec. 10.75 by the office of the 
Commissioner of Food and Drugs. A determination by the Director of the 
Center for Food Safety and Applied Nutrition that is not appealed 
becomes a final agency decision.
    (ii) After a final decision by the Director or by the office of the 
Commissioner that a product's exempt status is withdrawn, the 
manufacturer shall comply with the nutrient requirements of section 
412(g) of the act or of regulations promulgated under section 412(a)(2) 
of the act, the quality control requirements of part 106, and the 
labeling requirements of subpart B of this part.
    (iii) The compliance date for the withdrawal of a product's exempt 
status or the imposition of additional or modified quality control, 
nutrient, or labeling requirements is 60 calendar days after issuance of 
the final decision except as otherwise provided for reasons stated in 
the decision. If the agency determines that a health hazard may exist 
and so notifies the

[[Page 186]]

manufacturer, withdrawal of a product's exempt status shall be effective 
on the date of receipt of notification from the Director of the Center 
for Food Safety and Applied Nutrition. Additional or modified 
requirements, or the withdrawal of an exemption, apply only to those 
formulas that are manufactured after the compliance date. A postponement 
of the compliance date may be granted for good cause.
    (3) FDA may decide that withdrawal of an exemption is necessary 
when, on the basis of its review under paragraph (d)(1) of this section, 
it concludes that quality control procedures are not adequate to ensure 
that the formula contains all required nutrients, that deviations in 
nutrient levels are not supported by generally accepted scientific, 
nutritional, or medical rationale, or that deviations from subpart B of 
this part are not necessary to provide appropriate directions for 
preparation and use of the infant formula, or that additional labeling 
information is necessary.
    (4) FDA will use the following criteria in determining whether 
deviations from the requirements of this subpart are necessary and will 
adequately protect the public health:
    (i) A deviation from the nutrient requirements of section 412(g) of 
the act or of regulations promulgated under section 412(a)(2) of the act 
is necessary to provide an infant formula that is appropriate for the 
dietary management of a specific disease, disorder, or medical 
condition;
    (ii) For exempt infant formulas subject to paragraph (b) of this 
section, a deviation from the quality control procedures requirements of 
part 106 is necessary because of unusal or difficult technological 
problems in manufacturing the infant formula; and
    (iii) A deviation from the labeling requirements of subpart B of 
this part is necessary because label information, including pictograms 
and symbols required by those regulations, could lead to inappropriate 
use of the product.
    (e) Notification requirements. (1) Information required by 
paragraphs (b) and (c) of this section shall be submitted to Center for 
Food Safety and Applied Nutrition (HFS-450), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204.
    (2) The manufacturer shall promptly notify FDA when the manufacturer 
has knowledge (as defined in section 412(c)(2) of the act) that 
reasonably supports the conclusion that an exempt infant formula that 
has been processed by the manufacturer and that has left an 
establishment subject to the control of the manufacturer may not provide 
the nutrients required by paragraph (b) or (c) of this section, or when 
there is an exempt infant formula that may be otherwise adulterated or 
misbranded and if so adulterated or misbranded presents a risk of human 
health. This notification shall be made, by telephone, to the Director 
of the appropriate FDA district office specified in Sec. 5.115. After 
normal business hours (8 a.m. to 4:30 p.m.), the FDA emergency number, 
202-737-0448, shall be used. The manufacturer shall send a followup 
written confirmation to the Center for Food Safety and Applied Nutrition 
(HFS-605), Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, and to the appropriate FDA district office specified in 
Sec. 5.115.

(Information Collection requirements were approved by the Office of 
Management and Budget under control number 0910-0158)

[50 FR 48187, Nov. 22, 1985, as amended at 61 FR 14479, Apr. 2, 1996]