Yam dej twg xav tau rau kev sib xyaw ua kom tsis muaj menyuam?
Yam dej twg xav tau rau kev sib xyaw ua kom tsis muaj menyuam?

Video: Yam dej twg xav tau rau kev sib xyaw ua kom tsis muaj menyuam?

Video: Yam dej twg xav tau rau kev sib xyaw ua kom tsis muaj menyuam?
Video: Vim Kuv Tsis Muaj 10,000$ Thiaj Ua Tshoob Tsis Tau Nrog Koj 03/17/2022 2024, Lub Xya hli ntuj
Anonim

Ua kom dawb huv Dej (saib Purified Dej monograph) yuav tsum siv rau compounding nonsterile kev npaj tshuaj thaum tsim qauv qhia txog kev suav nrog dej . Ua kom dawb huv Dej yuav tsum tau siv rau yaug cov cuab yeej thiab cov tais diav.

Los ntawm qhov ntawd, cov pawg ntawm kev sib xyaw ua kom tsis muaj kab mob sib kis yog dab tsi?

USP txhais peb pawg ntawm nonsterile compounding : yooj yim, nruab nrab, thiab nyuaj.

Tom qab ntawd, lo lus nug yog, puas tau rov tsim kho dua tshiab? FDA hais tias " Sib xyaw tsis suav nrog kev sib xyaw, rov tsim dua tshiab , lossis kev ua haujlwm zoo ib yam uas tau ua raws li cov lus qhia muaj hauv daim ntawv pom zoo muab los ntawm cov khoom lag luam thiab lwm cov lus qhia ntawm cov khoom lag luam zoo ib yam nrog daim ntawv lo "[21 USC 321 (k) thiab (m)].

Khaws qhov no saib, dab tsi yog qhov tsis yooj yim kom tsis muaj menyuam sib xyaw?

Complex tsis - tsis muaj menyuam tsis taus : ua ke ntawm kev npaj tshuaj uas xav tau kev qhia tshwj xeeb, ib puag ncig tshwj xeeb lossis chaw tshwj xeeb lossis khoom siv lossis kev siv ua ke cov txheej txheem thiab txheej txheem uas tuaj yeem ua rau muaj kev pheej hmoo siab rau tus neeg sib xyaw lossis tus neeg mob.

USP 797 cov lus qhia suav nrog dab tsi?

NPE 797 muab yam tsawg kawg xyaum thiab ua tau zoo cov qauv rau CSPs ntawm cov tshuaj thiab cov as -ham, raws li cov ntaub ntawv tshawb fawb tam sim no thiab kev ua kom tsis muaj menyuam zoo tshaj plaws ua ke ua raws. Tshooj lus hais USP 797 tus qauv rau kev ntxuav thiab tua kab mob hauv chav tsev muag tshuaj huv, nrog rau cov khoom uas yuav tsum tau siv.

Pom zoo: