{"id":3209,"date":"2026-08-08T20:04:03","date_gmt":"2026-08-08T20:04:03","guid":{"rendered":"https:\/\/guanmalabel.com\/?p=3209"},"modified":"2026-08-08T20:04:03","modified_gmt":"2026-08-08T20:04:03","slug":"fda-compliant-label-materials-food-packaging","status":"publish","type":"post","link":"https:\/\/guanmalabel.com\/vi\/blog\/fda-compliant-label-materials-food-packaging\/","title":{"rendered":"V\u1eadt li\u1ec7u nh\u00e3n tu\u00e2n th\u1ee7 FDA cho bao b\u00ec th\u1ef1c ph\u1ea9m"},"content":{"rendered":"
\n

C\u1eadp nh\u1eadt th\u00e1ng 8 n\u0103m 2026 \u00b7 Ph\u1ea1m vi li\u00ean h\u1ec7 th\u1ef1c ph\u1ea9m c\u1ee7a Hoa K\u1ef3 \u00b7 H\u01b0\u1edbng d\u1eabn x\u00e1c minh ph\u00eda ng\u01b0\u1eddi mua<\/p>\n

v\u1eadt li\u1ec7u nh\u00e3n tu\u00e2n th\u1ee7 FDA cho bao b\u00ec th\u1ef1c ph\u1ea9m<\/strong> kh\u00f4ng \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh b\u1edfi m\u1ed9t logo, t\u00ean nh\u1ef1a, ho\u1eb7c c\u00e2u nh\u00e0 cung c\u1ea5p. l\u1ef1a ch\u1ecdn c\u00f3 th\u1ec3 b\u1ea3o v\u1ec7 li\u00ean k\u1ebft m\u1ecdi ch\u1ea5t c\u00f3 li\u00ean quan trong nh\u00e3n th\u00e0nh ph\u1ea9m v\u1edbi c\u01a1 s\u1edf ph\u00e1p l\u00fd hi\u1ec7n h\u00e0nh c\u1ee7a Hoa K\u1ef3, \u0111\u01b0\u1eddng d\u1eabn li\u00ean l\u1ea1c d\u1ef1 \u0111\u1ecbnh, \u0111i\u1ec1u ki\u1ec7n s\u1eed d\u1ee5ng v\u00e0 s\u1eeda \u0111\u1ed5i x\u00e2y d\u1ef1ng c\u00f3 ki\u1ec3m so\u00e1t. hi\u1ec7u su\u1ea5t v\u1eadt l\u00fd tr\u00ean g\u00f3i th\u1ef1c sau \u0111\u00f3 c\u1ea7n b\u1eb1ng ch\u1ee9ng ri\u00eang c\u1ee7a n\u00f3.<\/p>\n

H\u01b0\u1edbng d\u1eabn n\u00e0y d\u00e0nh cho ng\u01b0\u1eddi mua bao b\u00ec \u0111\u00e3 bi\u1ebft c\u00e1c t\u00f9y ch\u1ecdn v\u1eadt li\u1ec7u r\u1ed9ng v\u00e0 b\u00e2y gi\u1edd c\u1ea7n x\u00e1c minh vi\u1ec7c x\u00e2y d\u1ef1ng.\u0110\u1ec3 so s\u00e1nh chung v\u1ec1 l\u1ef1a ch\u1ecdn gi\u1ea5y v\u00e0 phim, h\u00e3y b\u1eaft \u0111\u1ea7u v\u1edbi Guanma L\u1eeba t\u1ed5ng quan v\u1ec1 \u0111\u1ecbnh d\u1ea1ng nh\u00e3n v\u00e0 tr\u01b0\u1eddng h\u1ee3p s\u1eed d\u1ee5ng<\/a>; quy tr\u00ecnh l\u00e0m vi\u1ec7c b\u00ean d\u01b0\u1edbi b\u1eaft \u0111\u1ea7u khi danh s\u00e1ch r\u00fat g\u1ecdn tr\u1edf th\u00e0nh t\u1ec7p tu\u00e2n th\u1ee7.<\/p>\n

\nC\u00e2u tr\u1ea3 l\u1eddi ng\u1eafn g\u1ecdn<\/strong><\/p>\n

Ch\u1ec9 \u0111\u1ecbnh nh\u00e3n in ho\u00e0n ch\u1ec9nh, ph\u00e2n lo\u1ea1i c\u00e1ch b\u1ea5t k\u1ef3 ch\u1ea5t n\u00e0o c\u00f3 th\u1ec3 ti\u1ebfp c\u1eadn th\u1ef1c ph\u1ea9m, x\u00e1c minh l\u1ed9 tr\u00ecnh \u1ee7y quy\u1ec1n hi\u1ec7n h\u00e0nh v\u00e0 gi\u1edbi h\u1ea1n s\u1eed d\u1ee5ng, sau \u0111\u00f3 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n b\u00e1m d\u00ednh, m\u00e0i m\u00f2n, ng\u01b0ng t\u1ee5, \u0111\u1ed9 b\u1ec1n in v\u00e0 x\u1eed l\u00fd tr\u00ean g\u00f3i th\u1ef1c t\u1ebf. tuy\u00ean b\u1ed1 th\u00e0nh ph\u1ea7n \u0111\u00f3 c\u00f3 th\u1ec3 h\u1ed7 tr\u1ee3 t\u1ec7p; n\u00f3 c\u00f3 th\u1ec3 t\u1ef1 \u0111\u1ed9ng bao g\u1ed3m vi\u1ec7c x\u00e2y d\u1ef1ng \u0111\u00e3 ho\u00e0n th\u00e0nh.<\/p>\n<\/div>\n

\"Tu\u00e2n<\/figure>\n

Tu\u00e2n th\u1ee7 FDA c\u00f3 ngh\u0129a l\u00e0 g\u00ec \u0111\u1ed1i v\u1edbi vi\u1ec7c x\u00e2y d\u1ef1ng nh\u00e3n th\u00e0nh ph\u1ea9m<\/h2>\n

\u0110\u1ed1i v\u1edbi nh\u00e3n bao b\u00ec th\u1ef1c ph\u1ea9m, \u201ctu\u00e2n th\u1ee7 FDA\u201d c\u00f3 ngh\u0129a l\u00e0 c\u00e1c ch\u1ea5t \u0111\u01b0\u1ee3c d\u1ef1 ki\u1ebfn di chuy\u1ec3n h\u1ee3p l\u00fd l\u00e0 h\u1ee3p ph\u00e1p cho m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng \u0111\u00e3 x\u00e1c \u0111\u1ecbnh v\u00e0 vi\u1ec7c x\u00e2y d\u1ef1ng \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n theo c\u00e1c quy \u0111\u1ecbnh chung hi\u1ec7n h\u00e0nh. N\u00f3 kh\u00f4ng ng\u1ee5 \u00fd r\u1eb1ng C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 \u0111\u00e3 c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn ph\u00ea duy\u1ec7t chung cho m\u1ecdi k\u1ebft h\u1ee3p v\u1eadt li\u1ec7u, ch\u1ea5t k\u1ebft d\u00ednh, m\u1ef1c, l\u1edbp ph\u1ee7 v\u00e0 g\u00f3i.<\/p>\n

21 CFR 174,5<\/a> cung c\u1ea5p khung chung cho ph\u1ee5 gia th\u1ef1c ph\u1ea9m gi\u00e1n ti\u1ebfp. s\u1eed d\u1ee5ng \u0111\u01b0\u1ee3c ph\u00e9p v\u1eabn c\u00f2n ph\u1ea3i th\u1ef1c h\u00e0nh s\u1ea3n xu\u1ea5t t\u1ed1t, \u0111\u1ed9 tinh khi\u1ebft ph\u00f9 h\u1ee3p, c\u00e1c quy \u0111\u1ecbnh \u00e1p d\u1ee5ng kh\u00e1c c\u1ee7a \u0110\u1ea1o lu\u1eadt Th\u1ef1c ph\u1ea9m, D\u01b0\u1ee3c ph\u1ea9m v\u00e0 M\u1ef9 ph\u1ea9m Li\u00ean bang, v\u00e0 y\u00eau c\u1ea7u kh\u00f4ng l\u00e0m cho th\u1ef1c ph\u1ea9m kh\u00f4ng ph\u00f9 h\u1ee3p th\u00f4ng qua m\u00f9i ho\u1eb7c v\u1ecb. \u1ee7y quy\u1ec1n cho s\u1eed d\u1ee5ng gi\u00e1n ti\u1ebfp c\u0169ng kh\u00f4ng ng\u1ee5 \u00fd cho ph\u00e9p s\u1eed d\u1ee5ng c\u00f9ng m\u1ed9t ch\u1ea5t nh\u01b0 ph\u1ee5 gia th\u1ef1c ph\u1ea9m tr\u1ef1c ti\u1ebfp.<\/p>\n

S\u1eed d\u1ee5ng Thang b\u1eb1ng ch\u1ee9ng \u0111\u01b0\u1eddng d\u1eabn ti\u1ebfp x\u00fac 4 b\u01b0\u1edbc<\/h3>\n

C\u00e2u h\u1ecfi mua h\u00e0ng \u0111\u1ea7u ti\u00ean l\u00e0't \u201cV\u1eadt li\u1ec7u nh\u00e3n n\u00e0o \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t?\u201d It's \u201cB\u1eb1ng con \u0111\u01b0\u1eddng th\u1ef1c t\u1ebf n\u00e0o m\u00e0 m\u1ed9t ch\u1ea5t trong c\u00f4ng tr\u00ecnh n\u00e0y c\u00f3 th\u1ec3 ti\u1ebfp c\u1eadn th\u1ef1c ph\u1ea9m?\u201d C\u00e2u tr\u1ea3 l\u1eddi \u0111\u00f3 x\u00e1c \u0111\u1ecbnh b\u1eb1ng ch\u1ee9ng n\u00e0o \u0111\u00e1ng \u0111\u01b0\u1ee3c ch\u00fa \u00fd v\u00e0 ng\u0103n kh\u00f4ng cho nh\u00e3n b\u00ean ngo\u00e0i b\u1ecb coi l\u00e0 t\u1ef1 \u0111\u1ed9ng kh\u00f4ng li\u00ean quan.<\/p>\n

\n\n\n\n\n\n\n\n\n
Thang b\u1eb1ng ch\u1ee9ng li\u00ean h\u1ec7-\u0111\u01b0\u1eddng d\u1eabn<\/caption>\n
Con \u0111\u01b0\u1eddng<\/th>\nC\u00e2u h\u1ecfi v\u00ed d\u1ee5<\/th>\nT\u1eadp trung b\u1eb1ng ch\u1ee9ng<\/th>\nRanh gi\u1edbi quy\u1ebft \u0111\u1ecbnh<\/th>\n<\/tr>\n<\/thead>\n
1. d\u1ef1 \u0111\u1ecbnh li\u00ean h\u1ec7 tr\u1ef1c ti\u1ebfp<\/th>\nB\u1ec1 m\u1eb7t d\u00e1n nh\u00e3n ho\u1eb7c ch\u1ea5t k\u1ebft d\u00ednh c\u00f3 th\u1ec3 c\u1ed1 \u00fd ch\u1ea1m v\u00e0o th\u1ef1c ph\u1ea9m kh\u00f4ng?<\/td>\nC\u01a1 s\u1edf ph\u00e1p l\u00fd c\u1ee5 th\u1ec3 v\u00e0 \u0111i\u1ec1u ki\u1ec7n cho vi\u1ec7c li\u00ean h\u1ec7 tr\u1ef1c ti\u1ebfp \u0111\u00f3<\/td>\nKh\u00f4ng suy ra s\u1ef1 cho ph\u00e9p t\u1eeb tr\u00edch d\u1eabn s\u1eed d\u1ee5ng gi\u00e1n ti\u1ebfp<\/td>\n<\/tr>\n
2. ti\u1ebfp x\u00fac d\u1ea5u v\u1ebft t\u1ea1i \u0111\u01b0\u1eddng n\u1ed1i ho\u1eb7c c\u1ea1nh<\/th>\nCh\u1ea5t k\u1ebft d\u00ednh c\u00f3 th\u1ec3 b\u1ecb \u00e9p ra, b\u1ecb c\u1eaft c\u1ea1nh ho\u1eb7c v\u1ecb tr\u00ed nh\u00e3n c\u00f3 th\u1ec3 t\u1ea1o ra s\u1ef1 ti\u1ebfp x\u00fac kh\u00f4ng?<\/td>\nH\u00ecnh h\u1ecdc, s\u1ed1 l\u01b0\u1ee3ng \u1ee9ng d\u1ee5ng, v\u1ecb tr\u00ed v\u00e0 gi\u1edbi h\u1ea1n quy \u0111\u1ecbnh ch\u00ednh x\u00e1c<\/td>\nB\u1ea3n v\u1ebd ph\u1eb3ng c\u00f3 th\u1ec3 b\u1ecf l\u1ee1 \u0111\u01b0\u1eddng d\u1eabn ti\u1ebfp x\u00fac s\u1ea3n xu\u1ea5t<\/td>\n<\/tr>\n
3. chuy\u1ec3n qua h\u1ec7 th\u1ed1ng g\u00f3i<\/th>\nM\u1ed9t ch\u1ea5t c\u00f3 th\u1ec3 di chuy\u1ec3n b\u1eb1ng c\u00e1ch di chuy\u1ec3n, b\u00f9 tr\u1eeb, th\u00e2m nh\u1eadp ho\u1eb7c m\u1ed9t con \u0111\u01b0\u1eddng kh\u00e1c kh\u00f4ng?<\/td>\nL\u1edbp g\u00f3i, lo\u1ea1i th\u1ef1c ph\u1ea9m, th\u1eddi gian, nhi\u1ec7t \u0111\u1ed9, b\u1ea3o qu\u1ea3n v\u00e0 b\u1eb1ng ch\u1ee9ng chuy\u1ec3n giao<\/td>\n\u201cNgo\u1ea1i th\u1ea5t\u201d l\u00e0 m\u1ed9t \u0111\u1ecba \u0111i\u1ec3m, kh\u00f4ng ph\u1ea3i l\u00e0 m\u1ed9t \u0111\u00e1nh gi\u00e1 ph\u01a1i s\u00e1ng ho\u00e0n ch\u1ec9nh<\/td>\n<\/tr>\n
4. r\u00e0o c\u1ea3n hi\u1ec7u qu<\/th>\nLi\u1ec7u m\u1ed9t r\u00e0o c\u1ea3n \u0111\u00e3 \u0111\u01b0\u1ee3c x\u00e1c minh c\u00f3 ng\u0103n c\u1ea3n ch\u1ea5t li\u00ean quan \u0111\u1ebfn th\u1ef1c ph\u1ea9m kh\u00f4ng?<\/td>\nNh\u1eadn d\u1ea1ng r\u00e0o c\u1ea3n, t\u00ednh to\u00e0n v\u1eb9n, qu\u00e1 tr\u00ecnh chuy\u1ec3n \u0111\u1ed5i v\u00e0 c\u00e1c \u0111i\u1ec1u ki\u1ec7n d\u1ef1 \u0111\u1ecbnh<\/td>\nGi\u1ea3 \u0111\u1ecbnh v\u1ec1 r\u00e0o c\u1ea3n ph\u1ea3i ph\u00f9 h\u1ee3p v\u1edbi g\u00f3i \u0111\u00e3 b\u00e1n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

Thang n\u00e0y t\u00e1ch bi\u1ec7t an to\u00e0n v\u1eadt li\u1ec7u v\u1edbi ghi nh\u00e3n th\u1ef1c ph\u1ea9m h\u01b0\u1edbng t\u1edbi ng\u01b0\u1eddi ti\u00eau d\u00f9ng, m\u1eb7c d\u00f9 c\u00e1c t\u00ecm ki\u1ebfm cho \u201cnh\u00e3n bao b\u00ec th\u1ef1c ph\u1ea9m tu\u00e2n th\u1ee7 FDA\u201d th\u01b0\u1eddng tr\u1ed9n l\u1eabn hai. y\u00eau c\u1ea7u ghi nh\u00e3n cho S\u1ef1 ki\u1ec7n dinh d\u01b0\u1ee1ng, ch\u1ea5t g\u00e2y d\u1ecb \u1ee9ng, tuy\u00ean b\u1ed1 nh\u1eadn d\u1ea1ng v\u00e0 s\u1ed1 l\u01b0\u1ee3ng r\u00f2ng li\u00ean quan \u0111\u1ebfn nh\u1eefng g\u00ec nh\u00e3n th\u1ef1c ph\u1ea9m ho\u00e0n th\u00e0nh n\u00f3i; b\u00e0i vi\u1ebft n\u00e0y li\u00ean quan \u0111\u1ebfn c\u00e1c v\u1eadt li\u1ec7u \u0111\u00f3ng g\u00f3i b\u00ean d\u01b0\u1edbi t\u00e1c ph\u1ea9m ngh\u1ec7 thu\u1eadt \u0111\u00f3. c\u1ea3 hai \u0111\u00e1nh gi\u00e1 \u0111\u1ec1u g\u00f3p ph\u1ea7n v\u00e0o an to\u00e0n th\u1ef1c ph\u1ea9m, nh\u01b0ng kh\u00f4ng thay th\u1ebf cho c\u00e1i kia.<\/p>\n

Ph\u1ea1m vi n\u00e0y ph\u00e2n chia v\u1ea5n \u0111\u1ec1 cho c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t th\u1ef1c ph\u1ea9m v\u00e0 ng\u00e0nh c\u00f4ng nghi\u1ec7p th\u1ef1c ph\u1ea9m r\u1ed9ng l\u1edbn h\u01a1n, bao g\u1ed3m c\u00e1c nh\u00e3n hi\u1ec7u th\u1ef1c ph\u1ea9m v\u00e0 \u0111\u1ed3 u\u1ed1ng.A nh\u00e3n Nutrition Facts, tuy\u00ean b\u1ed1 v\u1ec1 ch\u1ea5t g\u00e2y d\u1ecb \u1ee9ng v\u00e0 c\u00e1c y\u00eau c\u1ea7u nh\u00e3n th\u1ef1c ph\u1ea9m kh\u00e1c thu\u1ed9c v\u1ec1 ghi nh\u00e3n FDA \u0111\u1ed1i m\u1eb7t v\u1edbi ng\u01b0\u1eddi ti\u00eau d\u00f9ng; H\u01b0\u1edbng d\u1eabn ghi nh\u00e3n th\u1ef1c ph\u1ea9m c\u1ee7a FDA t\u00f3m t\u1eaft nhi\u1ec1u y\u00eau c\u1ea7u v\u1ec1 ghi nh\u00e3n th\u1ef1c ph\u1ea9m, trong khi c\u00e1c y\u00eau c\u1ea7u ph\u00e1p l\u00fd v\u1ec1 ghi nh\u00e3n th\u1ef1c ph\u1ea9m c\u0169ng c\u00f3 th\u1ec3 d\u1ef1a tr\u00ean c\u00e1c \u0111\u1ea1o lu\u1eadt v\u00e0 quy \u0111\u1ecbnh ngo\u00e0i \u1ee7y quy\u1ec1n v\u1eadt li\u1ec7u. do \u0111\u00f3, c\u00e1c c\u00e2u h\u1ecfi v\u1ec1 y\u00eau c\u1ea7u ghi nh\u00e3n c\u1ee7a FDA, ghi nh\u00e3n dinh d\u01b0\u1ee1ng, nh\u00e3n cho th\u1ef1c ph\u1ea9m ho\u1eb7c th\u1ef1c ph\u1ea9m \u0111\u01b0\u1ee3c b\u00e1n \u1edf Hoa K\u1ef3 c\u1ea7n \u0111\u01b0\u1ee3c xem x\u00e9t ri\u00eang v\u00e0 kh\u00f4ng th\u1ec3 ch\u1ee9ng minh r\u1eb1ng v\u1eadt li\u1ec7u nh\u00e3n nh\u1ef1a an to\u00e0n khi ti\u1ebfp x\u00fac v\u1edbi th\u1ef1c ph\u1ea9m.<\/p>\n

\"Ki\u1ec3m<\/figure>\n

Ki\u1ec3m tra Gi\u1ea5y ph\u00e9p Keo d\u01b0\u1edbi 21 CFR 175.105<\/h2>\n

V\u1edbi \u0111\u01b0\u1eddng d\u1eabn li\u00ean l\u1ea1c \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i, tr\u00edch d\u1eabn d\u00ednh ch\u1ec9 h\u1eefu \u00edch khi ng\u01b0\u1eddi mua \u0111\u1ecdc c\u00e1c \u0111i\u1ec1u ki\u1ec7n v\u00e0 gi\u1edbi h\u1ea1n c\u1ee7a n\u00f3.M\u1ee5c 175.105 kh\u00f4ng ph\u1ea3i l\u00e0 ph\u00ea duy\u1ec7t ti\u1ebfp x\u00fac tr\u1ef1c ti\u1ebfp th\u1ef1c ph\u1ea9m kh\u00f4ng h\u1ea1n ch\u1ebf v\u00e0 n\u00f3 kh\u00f4ng ch\u1ee9ng minh r\u1eb1ng nh\u00e3n nh\u1ea1y c\u1ea3m v\u1edbi \u00e1p su\u1ea5t s\u1ebd v\u1eabn \u0111\u01b0\u1ee3c \u0111\u00ednh k\u00e8m, d\u1ec5 \u0111\u1ecdc v\u00e0 nguy\u00ean v\u1eb9n th\u00f4ng qua chu tr\u00ecnh chuy\u1ec3n \u0111\u1ed5i, l\u00e0m \u0111\u1ea7y, l\u01b0u tr\u1eef v\u00e0 ph\u00e2n ph\u1ed1i d\u1ef1 \u0111\u1ecbnh.<\/p>\n

V\u0103n b\u1ea3n hi\u1ec7n t\u1ea1i c\u1ee7a 21 CFR 175,105<\/a> \u0111\u1ecba ch\u1ec9 ch\u1ea5t k\u1ebft d\u00ednh \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng nh\u01b0 c\u00e1c th\u00e0nh ph\u1ea7n c\u1ee7a c\u00e1c b\u00e0i vi\u1ebft d\u00e0nh cho bao b\u00ec th\u1ef1c ph\u1ea9m, v\u1eadn chuy\u1ec3n, ho\u1eb7c n\u1eafm gi\u1eef.N\u00f3 ch\u1ec9 \u0111\u1ecbnh c\u00e1c c\u01a1 s\u1edf ch\u1ea5t \u0111\u01b0\u1ee3c ph\u00e9p v\u00e0 \u0111i\u1ec1u ki\u1ec7n s\u1eed d\u1ee5ng gi\u1edbi h\u1ea1n, bao g\u1ed3m c\u1ea3 vi\u1ec7c s\u1eed d\u1ee5ng \u0111\u1eb1ng sau m\u1ed9t r\u00e0o c\u1ea3n ch\u1ee9c n\u0103ng v\u00e0 \u0111i\u1ec1u ki\u1ec7n d\u1ea5u v\u1ebft-ti\u1ebfp x\u00fac \u0111\u00e3 n\u00eau.\u0110\u1ecdc ph\u1ea7n c\u00f9ng v\u1edbi \u00a7174.5 ch\u1ee9 kh\u00f4ng ph\u1ea3i tr\u00edch d\u1eabn s\u1ed1 c\u1ee7a n\u00f3 m\u1ed9t m\u00ecnh.<\/p>\n

\nSai l\u1ea7m th\u01b0\u1eddng g\u1eb7p<\/strong><\/p>\n

Gi\u1ea3 s\u1eed m\u1ed9t nh\u00e0 cung c\u1ea5p vi\u1ebft \u201cch\u1ea5t k\u1ebft d\u00ednh tu\u00e2n th\u1ee7 21 CFR 175.105,\u201d trong khi ng\u01b0\u1eddi mua kh\u00f4ng bao gi\u1edd ghi l\u1ea1i m\u00e3 s\u1ea3n ph\u1ea9m k\u1ebft d\u00ednh, tr\u1ecdng l\u01b0\u1ee3ng l\u1edbp ph\u1ee7, tuy\u1ebfn \u0111\u01b0\u1eddng ti\u1ebfp x\u00fac, r\u00e0o c\u1ea3n g\u00f3i, lo\u1ea1i th\u1ef1c ph\u1ea9m ho\u1eb7c \u0111i\u1ec1u ki\u1ec7n d\u1ecbch v\u1ee5. tr\u00edch d\u1eabn \u0111\u00f3 c\u00f3 th\u1ec3 l\u00e0 th\u1eadt, tuy nhi\u00ean t\u1ec7p v\u1eabn kh\u00f4ng th\u1ec3 hi\u1ec3n th\u1ecb r\u1eb1ng ph\u1ea1m vi \u0111\u01b0\u1ee3c tr\u00edch d\u1eabn kh\u1edbp v\u1edbi nh\u00e3n \u0111\u01b0\u1ee3c giao.<\/p>\n<\/div>\n

Y\u00eau c\u1ea7u nh\u00e0 cung c\u1ea5p ch\u1ea5t k\u1ebft d\u00ednh ho\u1eb7c c\u00f4ng c\u1ee5 chuy\u1ec3n \u0111\u1ed5i nh\u00e3n x\u00e1c \u0111\u1ecbnh v\u1eadt li\u1ec7u, \u0111o\u1ea1n v\u0103n hi\u1ec7n h\u00e0nh ho\u1eb7c c\u01a1 s\u1edf \u1ee7y quy\u1ec1n, gi\u1edbi h\u1ea1n, \u0111\u1ecba \u0111i\u1ec3m s\u1ea3n xu\u1ea5t ho\u1eb7c ng\u01b0\u1eddi th\u00f4ng b\u00e1o khi c\u00f3 li\u00ean quan v\u00e0 b\u1ea3n s\u1eeda \u0111\u1ed5i x\u00e2y d\u1ef1ng \u0111\u01b0\u1ee3c \u0111\u1ec1 c\u1eadp trong tuy\u00ean b\u1ed1. n\u1ebfu nh\u00e0 cung c\u1ea5p d\u1ef1a v\u00e0o r\u00e0o c\u1ea3n, ng\u01b0\u1eddi mua c\u0169ng n\u00ean x\u00e1c \u0111\u1ecbnh l\u1edbp r\u00e0o c\u1ea3n v\u00e0 x\u00e1c nh\u1eadn r\u1eb1ng r\u1ea1ch, c\u1eaft khu\u00f4n, \u0111\u01b0\u1eddng n\u1ed1i, n\u1ebfp g\u1ea5p ho\u1eb7c v\u1ecb tr\u00ed nh\u00e3n kh\u00f4ng \u0111\u00e1nh b\u1ea1i s\u1ef1 t\u00e1ch bi\u1ec7t gi\u1ea3 \u0111\u1ecbnh.<\/p>\n

Tu\u00e2n th\u1ee7 d\u00ednh v\u00e0 hi\u1ec7u su\u1ea5t d\u00ednh v\u1eabn l\u00e0 tr\u1ee5c quy\u1ebft \u0111\u1ecbnh ri\u00eang bi\u1ec7t.Ngay c\u1ea3 m\u1ed9t ch\u1ea5t h\u1ee3p ph\u00e1p c\u00f3 th\u1ec3 th\u1ea5t b\u1ea1i tr\u00ean m\u1ed9t g\u00f3i l\u1ea1nh, \u01b0\u1edbt, k\u1ebft c\u1ea5u, d\u1ea7u, cong, ho\u1eb7c b\u1ec1 m\u1eb7t th\u1ea5p-n\u0103ng l\u01b0\u1ee3ng; m\u1ed9t c\u00f4ng tr\u00ecnh cao v\u1ecf v\u1eabn c\u00f3 th\u1ec3 thi\u1ebfu b\u1eb1ng ch\u1ee9ng quy \u0111\u1ecbnh ph\u00f9 h\u1ee3p cho \u0111\u01b0\u1eddng d\u1eabn ti\u1ebfp x\u00fac d\u1ef1 \u0111\u1ecbnh.Mua s\u1eafm c\u1ea7n c\u1ea3 hai c\u1ed9t \u0111\u00f3ng.<\/p>\n

\"Theo<\/figure>\n

Theo d\u00f5i l\u1ed9 tr\u00ecnh \u1ee7y quy\u1ec1n \u00e1p d\u1ee5ng v\u00e0 FCN d\u00e0nh ri\u00eang cho nh\u00e0 cung c\u1ea5p<\/h2>\n

C\u00e1c ch\u1ea5t ti\u1ebfp x\u00fac v\u1edbi th\u1ef1c ph\u1ea9m c\u00f3 th\u1ec3 \u0111\u1ea1t \u0111\u1ebfn tr\u1ea1ng th\u00e1i h\u1ee3p ph\u00e1p th\u00f4ng qua c\u00e1c tuy\u1ebfn \u0111\u01b0\u1eddng kh\u00e1c nhau v\u00e0 c\u00e1c tuy\u1ebfn \u0111\u01b0\u1eddng \u0111\u00f3 kh\u00f4ng chia s\u1ebb c\u00e1c quy t\u1eafc ph\u1ee5 thu\u1ed9c gi\u1ed1ng h\u1ec7t nhau. Th\u00f4ng b\u00e1o li\u00ean h\u1ec7 th\u1ef1c ph\u1ea9m l\u00e0 c\u00f4ng ty, ch\u1ea5t v\u00e0 m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng c\u1ee5 th\u1ec3, trong khi FDA tuy\u00ean b\u1ed1 r\u1eb1ng ng\u01b0\u1ee1ng mi\u1ec5n tr\u1eeb Quy \u0111\u1ecbnh c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng b\u1edfi b\u1ea5t k\u1ef3 nh\u00e0 s\u1ea3n xu\u1ea5t ho\u1eb7c nh\u00e0 cung c\u1ea5p n\u00e0o cho c\u00e1c m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng v\u00e0 \u0111i\u1ec1u ki\u1ec7n \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh. Quy \u0111\u1ecbnh v\u1ec1 ph\u1ee5 gia th\u1ef1c ph\u1ea9m c\u00f3 ph\u1ea1m vi v\u00e0 gi\u1edbi h\u1ea1n ri\u00eang.<\/p>\n

c\u1ee7a FDA t\u1ed5ng quan v\u1ec1 tuy\u1ebfn \u0111\u01b0\u1eddng \u1ee7y quy\u1ec1n<\/a> gi\u1ea3i th\u00edch s\u1ef1 kh\u00e1c bi\u1ec7t n\u00e0y v\u00e0 c\u0169ng m\u00f4 t\u1ea3 th\u00f4ng tin di chuy\u1ec3n v\u00e0 ph\u01a1i nhi\u1ec5m \u0111\u01b0\u1ee3c xem x\u00e9t trong qu\u00e1 tr\u00ecnh \u0111\u00e1nh gi\u00e1 an to\u00e0n FCN. Ph\u1ea1m vi ch\u00ednh x\u00e1c, b\u1eb1ng ch\u1ee9ng \u0111\u00f3 h\u1ed7 tr\u1ee3 an to\u00e0n di chuy\u1ec3n m\u00e0 kh\u00f4ng t\u1ef1 \u0111\u1ed9ng ch\u1ee9ng minh m\u1ecdi thu\u1ed9c t\u00ednh \u1ee9ng d\u1ee5ng nh\u00e3n th\u00e0nh ph\u1ea9m.<\/p>\n

Vi\u1ec7c xem x\u00e9t v\u1eadt li\u1ec7u \u0111\u00f3ng g\u00f3i tu\u00e2n theo m\u1ed9t b\u1ed9 quy \u0111\u1ecbnh li\u00ean bang v\u00e0 quy \u0111\u1ecbnh \u0111\u00f3ng g\u00f3i kh\u00e1c nhau. c\u00e1c ngu\u1ed3n li\u00ean bang nh\u01b0 B\u1ed9 lu\u1eadt Quy \u0111\u1ecbnh Li\u00ean bang, quy \u0111\u1ecbnh c\u1ee7a FDA, quy t\u1eafc c\u1ee7a FDA v\u00e0 h\u01b0\u1edbng d\u1eabn c\u1ee7a FDA ph\u00e2n bi\u1ec7t c\u00e1c ch\u1ea5t \u0111\u01b0\u1ee3c th\u00eam v\u00e0o th\u1ef1c ph\u1ea9m v\u1edbi c\u00e1c v\u1eadt li\u1ec7u ti\u1ebfp x\u00fac v\u1edbi th\u1ef1c ph\u1ea9m v\u00e0 c\u00e1c v\u1eadt li\u1ec7u kh\u00e1c d\u00e0nh cho ti\u1ebfp x\u00fac tr\u1ef1c ti\u1ebfp ho\u1eb7c gi\u00e1n ti\u1ebfp v\u1edbi th\u1ef1c ph\u1ea9m; c\u00e1c ch\u1ea5t ti\u1ebfp x\u00fac \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i theo danh t\u00ednh, m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng v\u00e0 l\u1ed9 tr\u00ecnh ti\u1ebfp x\u00fac. b\u1eb1ng ch\u1ee9ng thay \u0111\u1ed5i khi m\u1ed9t th\u00e0nh ph\u1ea7n c\u00f3 th\u1ec3 ti\u1ebfp x\u00fac tr\u1ef1c ti\u1ebfp ho\u1eb7c gi\u00e1n ti\u1ebfp v\u1edbi th\u1ef1c ph\u1ea9m, t\u1ea1o ra ti\u1ebfp x\u00fac gi\u00e1n ti\u1ebfp, ti\u1ebfp x\u00fac tr\u1ef1c ti\u1ebfp v\u1edbi th\u1ef1c ph\u1ea9m ho\u1eb7c \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng tr\u1ef1c ti\u1ebfp cho th\u1ef1c ph\u1ea9m, do \u0111\u00f3 \u201c\u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t cho th\u1ef1c ph\u1ea9m\u201d ho\u1eb7c \u201c\u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn chung l\u00e0 an to\u00e0n\u201d kh\u00f4ng th\u1ec3 \u0111\u01b0\u1ee3c m\u01b0\u1ee3n nh\u01b0 m\u1ed9t y\u00eau c\u1ea7u nh\u00e3n cho m\u1ecdi m\u1ee5c \u0111\u00edch; t\u01b0\u01a1ng t\u1ef1 nh\u01b0 v\u1eady, c\u01a1 s\u1edf \u0111\u1ec3 s\u1eed d\u1ee5ng trong th\u1ef1c ph\u1ea9m kh\u00f4ng t\u1ef1 \u0111\u1ed9ng l\u00e0 c\u01a1 s\u1edf cho th\u00e0nh ph\u1ea7n nh\u00e3n ti\u1ebfp x\u00fac gi\u00e1n ti\u1ebfp.<\/p>\n

\n\n\n\n\n\n\n\n\n
Ki\u1ec3m tra l\u1ed9 tr\u00ecnh \u0111\u1ebfn h\u1ed3 s\u01a1<\/caption>\n
Tuy\u1ebfn \u0111\u01b0\u1eddng<\/th>\nNg\u01b0\u1eddi mua ph\u1ea3i kh\u1edbp<\/th>\nKi\u1ec3m tra \u0111\u1ed9 tin c\u1eady<\/th>\n\u0110\u1eebng gi\u1ea3 s\u1eed<\/th>\n<\/tr>\n<\/thead>\n
Th\u00f4ng b\u00e1o li\u00ean h\u1ec7 th\u1ef1c ph\u1ea9m<\/th>\nNg\u01b0\u1eddi th\u00f4ng b\u00e1o ho\u1eb7c nh\u00e0 s\u1ea3n xu\u1ea5t, ch\u1ea5t, th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt, m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng, gi\u1edbi h\u1ea1n v\u00e0 tr\u1ea1ng th\u00e1i hi\u1ec7u qu\u1ea3<\/td>\nB\u00ean \u0111\u01b0\u1ee3c cung c\u1ea5p v\u00e0 vi\u1ec7c s\u1eed d\u1ee5ng ph\u1ea3i ph\u00f9 h\u1ee3p v\u1edbi th\u00f4ng b\u00e1o c\u00f3 hi\u1ec7u l\u1ef1c<\/td>\nFCN c\u1ee7a m\u1ed9t c\u00f4ng ty kh\u00e1c bao g\u1ed3m m\u1ecdi nh\u00e0 cung c\u1ea5p<\/td>\n<\/tr>\n
Quy \u0111\u1ecbnh v\u1ec1 ph\u1ee5 gia th\u1ef1c ph\u1ea9m<\/th>\nNh\u1eadn d\u1ea1ng ch\u1ea5t, s\u1eed d\u1ee5ng theo quy \u0111\u1ecbnh, th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt v\u00e0 c\u00e1c h\u1ea1n ch\u1ebf \u0111\u00e3 n\u00eau<\/td>\nC\u00f4ng th\u1ee9c v\u00e0 c\u00e1ch s\u1eed d\u1ee5ng th\u1ef1c t\u1ebf ph\u00f9 h\u1ee3p v\u1edbi quy \u0111\u1ecbnh<\/td>\nTr\u00edch d\u1eabn m\u1ed9t s\u1ed1 ph\u1ea7n x\u00e1c nh\u1eadn nh\u00e3n \u0111\u00e3 ho\u00e0n th\u00e0nh<\/td>\n<\/tr>\n
Ng\u01b0\u1ee1ng mi\u1ec5n tr\u1eeb quy \u0111\u1ecbnh<\/th>\nCh\u1ea5t \u0111\u01b0\u1ee3c mi\u1ec5n, m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng c\u1ee5 th\u1ec3, \u0111i\u1ec1u ki\u1ec7n v\u00e0 m\u1ecdi h\u1ea1n ch\u1ebf<\/td>\nS\u1ef1 ph\u1ee5 thu\u1ed9c ph\u1ea3i ph\u00f9 h\u1ee3p v\u1edbi s\u1ef1 mi\u1ec5n tr\u1eeb do FDA m\u00f4 t\u1ea3<\/td>\nM\u1ed7i tuy\u1ebfn \u0111\u01b0\u1eddng \u0111\u1ec1u d\u00e0nh ri\u00eang cho nh\u00e0 s\u1ea3n xu\u1ea5t nh\u01b0 FCN<\/td>\n<\/tr>\n
X\u1eed ph\u1ea1t tr\u01b0\u1edbc ho\u1eb7c c\u01a1 s\u1edf h\u1ee3p ph\u00e1p kh\u00e1c<\/th>\nB\u1ea3n s\u1eafc, c\u01a1 s\u1edf l\u1ecbch s\u1eed ho\u1eb7c ph\u00e1p l\u00fd v\u00e0 ph\u1ea1m vi ch\u00ednh x\u00e1c<\/td>\nC\u00e1c nh\u00e0 cung c\u1ea5p n\u00ean gi\u1ea3i th\u00edch l\u00fd do t\u1ea1i sao c\u01a1 s\u1edf \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng<\/td>\nB\u1ea3o \u0111\u1ea3m chung ti\u1ebft l\u1ed9 l\u1ed9 tr\u00ecnh c\u01a1 b\u1ea3n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

Khi m\u1ed9t FCN \u0111\u01b0\u1ee3c tr\u00edch d\u1eabn, h\u00e3y t\u00ecm ki\u1ebfm FDA ki\u1ec3m k\u00ea th\u00f4ng b\u00e1o li\u00ean h\u1ec7 th\u1ef1c ph\u1ea9m hi\u1ec7u qu\u1ea3<\/a>. Ph\u00f9 h\u1ee3p v\u1edbi ng\u01b0\u1eddi th\u00f4ng b\u00e1o \u0111\u01b0\u1ee3c li\u1ec7t k\u00ea ho\u1eb7c nh\u00e0 s\u1ea3n xu\u1ea5t, ch\u1ea5t, m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng, gi\u1edbi h\u1ea1n v\u00e0 th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt \u0111\u1ec3 tuy\u00ean b\u1ed1 nh\u00e0 cung c\u1ea5p. ghi l\u1ea1i ng\u00e0y ki\u1ec3m tra v\u00ec t\u00ecnh tr\u1ea1ng hi\u1ec7u qu\u1ea3 c\u00f3 th\u1ec3 thay \u0111\u1ed5i.<\/p>\n

\n

B\u00e0i h\u1ecdc th\u1ef1c t\u1ebf c\u1ee7a Ti\u1ebfn s\u0129 Peter Coneski v\u00e0 Natalie Rainer:<\/strong> x\u00e1c \u0111\u1ecbnh nh\u1eadn d\u1ea1ng ch\u1ea5t, m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng, th\u1ecb tr\u01b0\u1eddng m\u1ee5c ti\u00eau, lo\u1ea1i th\u1ef1c ph\u1ea9m, nhi\u1ec7t \u0111\u1ed9 v\u00e0 th\u1eddi gian ti\u1ebfp x\u00fac tr\u01b0\u1edbc khi ch\u1ecdn g\u00f3i d\u1eef li\u1ec7u quy \u0111\u1ecbnh.<\/p>\n