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Start Over Subjects Drug Compounding -- standards ✖Remove constraint Subjects: Drug Compounding -- standards

1. Questionable billing for compounded topical drugs in Medicare Part D

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, August 2018
Subject(s):
Dermatologic Agents -- economics
Dermatologic Agents -- therapeutic use
Drug Compounding -- economics
Drug Utilization -- trends
Fraud
Insurance, Health, Reimbursement
Medicare Part D -- economics
Skin Cream -- economics
Administration, Topical
Dermatologic Agents -- adverse effects
Drug Compounding -- standards
Forecasting
Health Expenditures -- trends
Insurance Coverage
Skin Cream -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

2. 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.

3. 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.

8. 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.

9. 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.

10. 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.

11. 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
Chemistry, Pharmaceutical -- standards
Humans
United States
United States. Food and Drug Administration.

12. 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.