§2.125. Use of ozone-depleting substances in foods, drugs, devices, or cosmetics. — Inbound Citations
21 C.F.R. § 2.125
Statutory Authority
Cited by 8 regulations in release Current.
Citations to 21 C.F.R. § 2.125 as a whole
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The use of chlorofluorocarbons in human food as propellants in self-pressurized containers is prohibited as provided by § 2.125 of this chapter.
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The use of chlorofluorocarbons in human drugs as propellants in self-pressurized containers is generally prohibited except as provided by § 2.125 of this chapter.
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The use of chlorofluorocarbons in cosmetics as propellants in self-pressurized containers is prohibited as provided in § 2.125 of this chapter.
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The use of chlorofluorocarbon in devices as propellants in self-pressurized containers is generally prohibited except as provided in § 2.125 of this chapter.
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(vi) Certification that the essential-use CFCs will be used in the production of essential MDIs. If the MDIs are to be sold in the United States, the certification must state that MDIs produced with the transferred essential-use CFCs are listed as essential at 21 CFR 2.125, and were approved by the Food and Drug Administration before December 31, 2000. If the MDIs produced with the essential-use CFCs are to be sold outside the United States, the transferee must certify that the metered dose inhalers produced with the essential-use CFCs are considered essential by the importing country.
Citations to §2.125(e)
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(3) Aerosol products, except medical aerosols;
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(i) Medical devices listed in 21 CFR 2.125(e);
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(i) Medical devices listed in 21 CFR 2.125(e);