DOPATREE
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DOPATREE
HEALTHCARE SYSTEM
MEDICAL FIELDS (FIELDS OF MEDICINE)
MEDICAL FIELDS / TYPES
PHARMACY-ALL (DRUG DISPENSING, DRUG STORES, DRUGSTORES, APOTHECARY)
PHARMACY / RELATED
COMPOUNDING-ALL (DRUG COMPOUNDING, SECTION 503A, 503B, BULK SUBSTANCES, PHARMACY COMPOUNDING, COMPOUNDED PRODUCTS, BULKS LIST, OUTSOURCING FACILITIES, TRADITIONAL)
COMPOUNDING / LAWS AND REGULATIONS / US
Parents
COMPOUNDING-ALL (DRUG COMPOUNDING, SECTION 503A, 503B, BULK SUBSTANCES, PHARMACY COMPOUNDING, COMPOUNDED PRODUCTS, BULKS LIST, OUTSOURCING FACILITIES, TRADITIONAL)
Children
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 460.100 HOSPITAL PHARMACIES - STATUS AS DRUG MANUFACTURER. OCT 01, 1980.
US FDA. DRAFT GUIDANCE. CURRENT GOOD MANUFACTURING PRACTICE. GUIDANCE FOR HUMAN DRUG COMPOUNDING OUTSOURCING FACILITIES UNDER SECTION 503B OF THE FD&C ACT. JAN 2020. REV. 2.
US FDA. DRAFT GUIDANCE. HOSPITAL AND HEALTH SYSTEM COMPOUNDING UNDER SECTION 503A OF THE FEDERAL, FOOD, DRUG, AND COSMETIC ACT. REV. 1. OCT 2021.
US FDA. GUIDANCE. ADVERSE EVENT REPORTING FOR OUTSOURCING FACILITIES UNDER SECTION 503B OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. OCT 2015.
US FDA. GUIDANCE. COMPLIANCE POLICY FOR CERTAIN COMPOUNDING OF ORAL OXITRIPTAN (5-HTP) DRUG PRODUCTS FOR PATIENTS WITH TETRAHYDROBIOPTERIN (BH4) DEFICIENCY. JUL 2019.
US FDA. GUIDANCE. COMPOUNDED DRUG PRODUCTS THAT ARE ESSENTIALLY COPIES OF A COMMERCIALLY AVAILABLE DRUG PRODUCT UNDER SECTION 503A OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. JAN 2018.
US FDA. GUIDANCE. COMPOUNDED DRUG PRODUCTS THAT ARE ESSENTIALLY COPIES OF APPROVED DRUG PRODUCTS UNDER SECTION 503B OF THE FEDERAL, FOOD, DRUG AND COSMETIC ACT. JAN 2018.
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US FDA. GUIDANCE. INSANITARY CONDITIONS AT COMPOUNDING FACILITIES. NOV 2020.
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US FDA. GUIDANCE. INTERIM POLICY ON COMPOUNDING USING BULK DRUG SUBSTANCES UNDER SECTION 503B OF THE FEDERAL FOOD, DRUG AND COSMETIC ACT. JAN 2017. REV. 1.
US FDA. GUIDANCE. MIXING, DILUTING, OR REPACKAGING BIOLOGICAL PRODUCTS OUTSIDE THE SCOPE OF AN APPROVED BIOLOGICS LICNESE APPLICATION. JAN 2018.
US FDA. GUIDANCE. PHARMACY COMPOUNDING OF HUMAN DRUG PRODUCTS UNDER SECTION 503A OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. JUN 2016. REV. 2.
US FDA. GUIDANCE. PRESCRIPTION REQUIREMENT UNDER SECTION 503A OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. DEC 2016.
US FDA. GUIDANCE. REGISTRATION OF HUMAN DRUG COMPOUNDING OUTSOURCING FACILITIES UNDER SECTION 503B OF THE FD&C ACT. NOV 2014.
US FDA. GUIDANCE. REPACKAGING OF CERTAIN HUMAN DRUG PRODUCTS BY PHARMACIES AND OUTSOURCING FACILITIES. JAN 2017.
US FDA. GUIDANCE. SECTION 503A BULKS LIST. FINAL RULE. QUESTIONS AND ANSWERS. SMALL ENTITY COMPLIANCE GUIDE. MAY 2019.
US FDA. GUIDANCE. TEMPORARY POLICY FOR COMPOUNDING OF CERTAIN DRUGS FOR HOSPITALIZED PATIENTS BY OUTSOURCING FACILITIES DURING THE COVID-19 PUBIC HEALTH EMERGENCY. MAY 21, 2020.
US FDA. GUIDANCE. TEMPORARY POLICY FOR COMPOUNDING OF CERTAIN DRUGS FOR HOSPITALIZED PATIENTS BY PHARMACY COMPOUNDERS NOT REGISTERED AS OUTSOURCING FACILITIES DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. MAY 21, 2020.
US FDA. GUIDANCE. TEMPORARY POLICY REGARDING NON-STANDARD PPE PRACTICES FOR STERILE COMPOUNDING BY PHARMACY COMPOUNDERS NOT REGISTERED AS OUTSOURCING FACILITIES DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. MAY 14, 2020.