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" A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and... "
Code of Federal Regulations: Containing a Codification of Documents of ... - 20. lappuse
2001
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Code of Federal Regulations: Containing a Codification of Documents of ...

1983 - 420 lapas
...contents shall not be unreasonably large. Subpart D — Exemptions From Adequate Directions for U>e § 801.109 Prescription devices. A device which, because...use" cannot be prepared, shall be exempt from section 502(f)(1) of the act if all the following conditions are met: (a) The device is: (1) (i) In the possession...
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Juvenile Dieting, Unsafe Over-the-counter Diet Products, and ..., 4. sējums

United States. Congress. House. Committee on Small Business. Subcommittee on Regulation, Business Opportunities, and Energy - 1990 - 340 lapas
...is a habit-forming drug listed in section 502(d) of the Act; (B) "because of its toxicity or other potentiality for harmful effect, or the method of...collateral measures necessary to Its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug"; or...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1994 - 640 lapas
...unreasonably large. Subpart D— Exemptions From Adequate Directions for Use $801.109 Prescription device«. A device which, because of any potentiality for harmful...use" cannot be prepared, shall be exempt from section 502(f)d) of the act if all the following conditions are met: (a) The device is: (1) (i) In the possession...
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Federal Food, Drug, and Cosmetic Act, As Amended

DIANE Publishing Company - 1994 - 226 lapas
...(A) is a habit-forming drug to which section 502(d) applies; or (B) because of its toxicity or other potentiality for harmful effect, or the method of...collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or...
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Validation Compliance Biannual 1996-1997

International Validation Forum - 1996 - 860 lapas
...which(A) is a habit-forming drug to which section 502(d) applies; or (B) because of its toxicity or other potentiality for harmful effect, or the method of...collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or...
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Recent Developments which May Impact Consumer Access To, and ..., 4. sējums

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health - 2001 - 248 lapas
...drugs. This section reads: A drug intended for use by man which — (A) because of its toxicity or other potentiality for harmful effect, or the method of...collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or...
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The Code of Federal Regulations of the United States of America

2004 - 756 lapas
...under 40 CFR part 82. [61 FR 20101, May 3. 1996] Subpart D— Exemptions From Adequate Directions tor Use § 801.109 Prescription devices. A device which,...use" cannot be prepared, shall be exempt from section 502(f)(1) of the act if all the following conditions are met: (a) The device is: (1)(i) In the possession...
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Pharmacy Practice and the Law

Richard R. Abood, David B. Brushwood - 2005 - 396 lapas
...provides in part (b)(l) A drug intended for use by man which — (A) because of its toxicity or other potentiality for harmful effect, or the method of...collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or...
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The Code of Federal Regulations of the United States of America

1987 - 488 lapas
...practice will be recognized. Variations from stated quantity of contents shall not be unreasonably large. Subpart D — Exemptions From Adequate Directions...use" cannot be prepared, shall be exempt from section 502(f)(1) of the act if all the following conditions are met: (a) The device is: (1) (i) In the possession...
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The Code of Federal Regulations of the United States of America

1968 - 416 lapas
...with paragraph (b) of this section and subparagraphs (4) and (5) of this paragraph. (d) Exemption for prescription devices. A device which, because of any...use" cannot be prepared, shall be exempt from section 502 (f) (1) of the act if all the following conditions are met: (1) The device is: (i) (a) In the possession...
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