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1. 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

2. 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

3. 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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.

4. Compounding certain ibuprofen oral suspension products under section 503B of the Federal Food, Drug, and Cosmetic Act

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, April 2023

Subject(s):

Administration, Oral
Drug Compounding -- methods
Drug Compounding -- standards
Drug Industry
Government Regulation
Ibuprofen
Legislation, Drug
Suspensions
United States
United States. Food and Drug Administration
United States.

5. Policy for testing of alcohol (ethanol) and isopropyl alcohol for methanol: guidance for industry

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, October 2023

Subject(s):

2-Propanol -- analysis
Drug Compounding -- standards
Drug Contamination -- prevention & control
Drug Industry
Ethanol -- analysis
Government Regulation
Methanol -- poisoning
United States

6. Gray's prescriptionist: a treatise on the art of reading and compounding physicians' prescriptions, with tables of weights and measures, antidotes, abbreviations, etc

Author(s):

Gray, H. C. (Harry C.) author

Publication:

Chicago, Ill. : M.M. Gray & Company, Publishers, 1920

Subject(s):

Drug Prescriptions -- standards
Handwriting
Pharmaceutical Preparations -- administration & dosage
Drug Compounding -- standards
Poisons

7. Most hospitals obtain compounded drugs from outsourcing facilities, which must meet FDA quality standards

Publication:

[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, June 2019

Subject(s):

Drug Compounding -- standards
Medicare
Outsourced Services
Purchasing, Hospital
Quality Control
United States
United States. Food and Drug Administration

8. 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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.

9. 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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.

10. 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
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration