(i) (ii) 2014 6 1 OBM 2014 10 1 73
(1) (2) (3) 2014 2 12 2014 6 1 2014 12 29 2015 3 1 GMP GMP 74
2011 1 1 2014 7 30 2014 10 1 1996 1 6 2015 6 1 2015 9 1 75
2014 7 30 2014 10 1 2011 5 20 2011 7 1 (1) (2) 76
(3) (4) (5) 1993 2 22 2009 8 27 2009 12 26 2010 7 1 1993 10 31 2013 10 25 2014 3 15 77
1994 7 5 1995 1 1 2009 8 27 2007 6 29 2012 12 28 2013 7 1 2008 9 18 2010 10 28 2011 7 1 1999 1 22 1999 3 19 2003 4 27 2010 12 201999 1 22 1994 12 14 1995 1 1 78
1999 4 3 2002 3 24 2002 6 29 2014 8 31 2014 12 1 1987 1 22 2000 7 8 2013 6 29 2013 12 28 2013 12 28 1994 5 12 2004 4 6 2004 7 1 1984 3 12 2009 10 1 79
1982 8 23 1993 2 22 2001 10 27 2013 8 30 2014 5 1 2002 8 3 2014 4 29 2014 5 1 2007 3 16 2008 1 1 2007 12 6 2008 1 1 25% 25% 1993 12 13 2008 11 10 2009 1 1 1993 12 25 2011 10 28 2011 11 1 80
17% 2011 11 16 2012 1 1 17% 13% 11% 6% 11% 6% 2016 3 23 2016 5 1 2016 5 1 2005 3 16 2005 5 1 2009 12 10 6982015 2 3 7 47 7 (i) (a) 80% (b) 80% (c)80% (ii) 81
(iii) 1985 2 8 1985 1 1 2011 1 8 1994 3 12 7% 5% 1% 1986 4 28 1986 7 1 2011 1 8 2011 1 8 3% 1986 4 12 2000 10 31 2000 10 31 1990 12 12 2014 2 19 2014 3 1 2015 3 102015 4 10 2002 2 11 2002 4 1 (1) (2) (3) (4) 82
1996 1 29 2008 8 52008 8 5 1996 6 20 1996 7 1 2015 2 13 2015 6 1 2015 3 30 2015 6 1 2016 6 9 83
2014 7 4 37 37 2003 7 GHTF (i) (ii)(iii) 2004 11 26 MDACS MDACS (i) (ii) (iii) MDCO MDACS MDACS MDCO 26 ) 84
71 456 ) 100,000500,000 1,000 362) (i) (ii) 500,000 231 50,000100,000 85
A. B. FDA FDA (i) National Formulary (ii) (iii) 21U.S.C. 321(h) FDA 1. FDA 21U.S.C. 360c FDA 1,700 16 21 C.F.R. 868 892 86
FDA FDA 510(k) FDA 510(k) FDA (21CFR 807.92(a)(3)) FDA 2. FDA 3. CGMP CGMP 4. FDA 10 1 12 31 FDA FDA FDA 87
5. FDA C. (1) (2) (3) UCC UCC D. 198665 800 88
FDA 65 2,500 3PDEHP BBP DBP 1,000 1,000 0.1% 65 HTS HTS 2016 FDA HTS 89