[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR2.125]
[Page 53-54]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 2 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS--Table of Contents
Subpart G Provisions Applicable to Specific Products Subject to the
Federal Food, Drug, and Cosmetic Act
Sec. 2.125 Use of ozone-depleting substances in foods, drugs, devices, or
cosmetics.
(a) As used in this section, ozone-depleting substance (ODS) means
any class I substance as defined in 40 CFR part 82, appendix A to
subpart A, or class II substance as defined in 40 CFR part 82, appendix
B to subpart A.
(b) Except as provided in paragraph (c) of this section, any food,
drug, device, or cosmetic that is, consists in part of, or is contained
in an aerosol product or other pressurized dispenser that releases an
ODS is not an essential use of the ODS under the Clean Air Act.
(c) A food, drug, device, or cosmetic that is, consists in part of,
or is contained in an aerosol product or other pressurized dispenser
that releases an ODS is an essential use of the ODS under the Clean Air
Act if paragraph (e) of this section specifies the use of that product
as essential. For drugs, including biologics and animal drugs, and for
devices, an investigational application or an approved marketing
application must be in effect, as applicable.
(d) [Reserved]
(e) The use of ODSs in the following products is essential:
(1) Metered-dose corticosteroid human drugs for oral inhalation.
Oral pressurized metered-dose inhalers containing the following active
moieties:
(i) Beclomethasone.
(ii) Dexamethasone.
(iii) Flunisolide.
(iv) Fluticasone.
(v) Triamcinolone.
(2) Metered-dose short-acting adrenergic bronchodilator human drugs
for oral inhalation. Oral pressurized metered-dose inhalers containing
the following active moieties:
(i) Albuterol.
(ii) Bitolterol.
(iii) Metaproterenol.
(iv) Pirbuterol.
(v) Epinephrine.
(3) [Reserved]
(4) Other essential uses. (i) Metered-dose salmeterol drug products
administered by oral inhalation for use in humans.
(ii) Metered-dose ergotamine tartrate drug products administered by
oral inhalation for use in humans.
(iii) Anesthetic drugs for topical use on accessible mucous
membranes of humans where a cannula is used for application.
(iv) Metered-dose cromolyn sodium human drugs administered by oral
inhalation.
(v) Metered-dose ipratropium bromide for oral inhalation.
(vi) Metered-dose atropine sulfate aerosol human drugs administered
by oral inhalation.
(vii) Metered-dose nedocromil sodium human drugs administered by
oral inhalation.
[[Page 54]]
(viii) Metered-dose ipratropium bromide and albuterol sulfate, in
combination, administered by oral inhalation for human use.
(ix) Sterile aerosol talc administered intrapleurally by
thoracoscopy for human use.
(f) Any person may file a petition under part 10 of this chapter to
request that FDA initiate rulemaking to amend paragraph (e) of this
section to add an essential use. FDA may initiate notice-and-comment
rulemaking to add an essential use on its own initiative or in response
to a petition, if granted.
(1) If the petition is to add use of a noninvestigational product,
the petitioner must submit compelling evidence that:
(i) Substantial technical barriers exist to formulating the product
without ODSs;
(ii) The product will provide an unavailable important public health
benefit; and
(iii) Use of the product does not release cumulatively significant
amounts of ODSs into the atmosphere or the release is warranted in view
of the unavailable important public health benefit.
(2) If the petition is to add use of an investigational product, the
petitioner must submit compelling evidence that:
(i) Substantial technical barriers exist to formulating the
investigational product without ODSs;
(ii) A high probability exists that the investigational product will
provide an unavailable important public health benefit; and
(iii) Use of the investigational product does not release
cumulatively significant amounts of ODSs into the atmosphere or the
release is warranted in view of the high probability of an unavailable
important public health benefit.
(g) Any person may file a petition under part 10 of this chapter to
request that FDA initiate rulemaking to amend paragraph (e) of this
section to remove an essential use. FDA may initiate notice-and-comment
rulemaking to remove an essential use on its own initiative or in
response to a petition, if granted. If the petition is to remove an
essential use from paragraph (e) of this section, the petitioner must
submit compelling evidence of any one of the following criteria:
(1) The product using an ODS is no longer being marketed; or
(2) After January 1, 2005, FDA determines that the product using an
ODS no longer meets the criteria in paragraph (f) of this section after
consultation with a relevant advisory committee(s) and after an open
public meeting; or
(3) For individual active moieties marketed as ODS products and
represented by one new drug application (NDA):
(i) At least one non-ODS product with the same active moiety is
marketed with the same route of administration, for the same indication,
and with approximately the same level of convenience of use as the ODS
product containing that active moiety;
(ii) Supplies and production capacity for the non-ODS product(s)
exist or will exist at levels sufficient to meet patient need;
(iii) Adequate U.S. postmarketing use data is available for the non-
ODS product(s); and
(iv) Patients who medically required the ODS product are adequately
served by the non-ODS product(s) containing that active moiety and other
available products; or
(4) For individual active moieties marketed as ODS products and
represented by two or more NDAs:
(i) At least two non-ODS products that contain the same active
moiety are being marketed with the same route of delivery, for the same
indication, and with approximately the same level of convenience of use
as the ODS products; and
(ii) The requirements of paragraphs (g)(3)(ii), (g)(3)(iii), and
(g)(3)(iv) of this section are met.
[67 FR 48384, July 24, 2002]
Effective Date Notes: 1. At 70 FR 17192, Apr. 4, 2005, Sec. 2.125
was amended by removing paragraph (e)(2)(i), effective December 31,
2008.
2. At 71 FR 70873, Dec. 7, 2006, Sec. 2.125 was amended by removing
and reserving paragraphs (e)(1)(i), (e)(1)(ii), (e)(1)(iv), (e)(2)(ii),
(e)(4)(i), (e)(4)(ii), and (e)(4)(v), effective Apr. 23, 2007, except
for Sec. 2.125(e)(4)(v) which is effective Aug. 1, 2007.
[[Page 55]]
Back to Top
© 2007 Betterchem Corp.
|
