17 
interpreted this section extremely 
broadly and neither they, a Senate 
Subcommittee, nor an inter-agency 
committee organized by the Secretary of 
HEW found any legal difficulties in 
applying the section to recombinant 
DNA . 28/ 
(2) The Food and Drug Administration has 
promulgated standards for both personnel 
and physical establishments dealing with 
biologies. 2_9 / To ensure industrial 
compliance, there is a dual licensing 
system (requiring licensing both of each 
product and of the establishment itself). 
FDA may issue an establishment license 
only after an inspection of the estab- 
lishment and the subsequent determina- 
tion that the facility meets the stan- 
dards prescribed in the regulations. 30 / 
(3) The standards in (2) are reinforced by 
the Good Manufacturing Practices 
required for drugs . ,31/ The 
implementing regulations specify 
28 / See McGarity and Bayer, 36 Vand. L. Rev. at 532, citing 
Korwek, The NTH Guidelines for Recombinant DNA Research 
and the Authority of FDA to Require Compliance with the 
Guidelines , 36 Food Drug Cosm. L.J. 633, 647 (1980); and 
Subcommittee on Science, Technology and Space, Senate 
Committee on Commerce, Science and Transportation, 95th 
Cong. , 2d Sess. , Oversight Report: Recombinant DNA 
Research and its Applications 23-24 (1978). 
29/ 42 U.S.C. § 262; 21 C.F.R. § 600.10-.12. 
30 / 21 C.F.R. § 601.10. Moreover, a license will be revoked if 
at any time "the establishment or any location thereof, . . 
. fails to conform to the applicable standards established 
in the license and in this Chapter, designed to ensure the 
continued safety, purity, and potency of the manufactured 
product . . . ." See 21 C.F.R. § 601.5(b)(4). 
31/ 21 U.S.C. § 351 (a)(2)(B). 
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