Subjects: 3 selected - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Drug Compounding -- standards ✖ Subjects United States. Department of Health and Human Services. ✖ Subjects United States. Food and Drug Administration. ✖

1. Liposome drug products: chemistry, manufacturing, and controls : human pharmacokinetics and bioavailability : and labeling documentation

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Drug Compounding -- standards
Liposomes -- chemistry
Liposomes -- pharmacokinetics
Biological Availability
Chemistry, Pharmaceutical
Liposomes -- administration & dosage
Liposomes -- therapeutic use
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. E11(R1) addendum: clinical investigation of medicinal products in the pediatric population

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Clinical Trials as Topic -- ethics
Drug Compounding -- standards
Pediatrics
Pharmaceutical Preparations
Child
Excipients
Infant
Infant, Newborn
International Cooperation
Models, Theoretical
Pharmaceutical Preparations -- administration & dosage
Taste
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Facility definition under Section 503B of the Federal Food, Drug, and Cosmetic Act

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Drug Compounding -- standards
Drug Industry -- standards
Contract Services
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

4. Q3C--tables and list

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, [June 2017]
Subject(s):: Chemistry, Pharmaceutical -- standards
Drug Compounding -- standards
Solvents -- classification
Congresses as Topic
International Cooperation
Solvents -- adverse effects
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. Compounded drug products that are essentially copies of a commercially available drug product under Section 503A of the Federal Food, Drug, and Cosmetic Act

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2018
Subject(s):: Drug Compounding -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

6. Compounded drug products that are essentially copies of approved drug products under Section 503B of the Federal Food, Drug, and Cosmetic Act

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2018
Subject(s):: Drug Compounding -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

7. Temporary policy for preparation of certain alcohol-based hand sanitizer products during the public health emergency (COVID-19)

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, February 10, 2021
Subject(s):: Drug Compounding -- methods
Drug Compounding -- standards
Ethanol
Hand Sanitizers
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8. Policy for temporary compounding of certain alcohol-based hand sanitizer products during the public health emergency: immediately in effect guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 10, 2021
Subject(s):: Drug Compounding -- methods
Drug Compounding -- standards
Ethanol
Hand Sanitizers
Methanol
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

9. Compliance policy for certain compounding of oral oxitriptan (5-HTP) drug products for patients with tetrahydrobiopterin (BH4) deficiency: immediately in effect guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2019
Subject(s):: Drug Compounding -- standards
5-Hydroxytryptophan -- therapeutic use
Phenylketonurias -- drug therapy
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.