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2.125 Use of ozone-depleting substances in foods, drugs, devices, or cosmetics.

Home > Regulations > General administrative rulings and decisions > 2.125 Use of ozone-depleting substances in foods, drugs, devices, or cosmetics.






[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: 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 Note: At 70 FR 17192, Apr. 4, 2005, Sec.  2.125 was 

amended by removing paragraph (e)(2)(i), effective December 31, 2008.



[[Page 55]]










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 2, Section 125


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