Compounding warning letters to 503A facilities between 2017 and 2021
The growing population demand and the epidemic lead of coronavirus disease 2019 have highlighted the critical importance of patient access to compounded formulations, including for special purposes such as pediatrics, geriatrics, and other uses. H...
Zhang Q, Liu X, Qian Y et al. — Journal of the American Pharmacists Association : JAPhA
The availability of gonadotropin therapy from FDA-approved pharmacies for men with hypogonadism and infertility
Recent changes to the Biologics Price Competition and Innovation Act of 2009 have created barriers to accessing therapy for men utilizing gonadotropins for hypogonadism and infertility.
Borgert BJ, Bacchus MW, Hernandez AD et al. — Sexual medicine
Clinical and Legal Considerations in Pharmaceutical Compounding
It is not uncommon for dermatologists to utilize compounded drug formulations to address specific patient needs that cannot be met using commercially available drugs. Some dermatology practices may derive certain economic benefits and convenience ...
Kircik L, Siegel DM — The Journal of clinical and aesthetic dermatology
Pharmacokinetics of a 503B outsourcing facility-produced theophylline in dogs
Theophylline is an important drug for treatment of canine chronic bronchitis and bradyarrhythmias, but new products require validation since pharmacokinetics in dogs can vary by formulation. A new, 503B outsourcing facility-produced theophylline p...
Reinhart JM, de Oliveira GAR, Forsythe L et al. — PloS one
Distinguishing between compounding facilities and the development of the 503B bulk drug substance list
The purpose of this commentary is to describe the differences between 503A and 503B facilities and the policies and restrictions for compounding from bulk drug substances. Due to the 2012 meningitis outbreak linked to compounded steroid injections...
Gianturco SL, Mattingly AN — Journal of the American Pharmacists Association : JAPhA
Documentation: Records and Reports
This article deals with documentation to include the beginning of documentation, the requirements of Good Manufacturing Practice reports and records, and the steps that can be taken to minimize Good Manufacturing Practice documentation problems. I...
Akers MJ — International journal of pharmaceutical compounding
Pharmacogenomics: Precision Pharmacy in 503A Compounding
The first recorded mention of a pharmacogenomic response may be that of Pythagoras in 510 BC, when he noted that hemolytic anemia developed in some but not all people who ingested fava beans. The application of such accounts to pharmacotherapy was...
Drummond J, Bennet D, Allen LV — International journal of pharmaceutical compounding
Certification, Accreditation, and Credentialing for 503A Compounding Pharmacies
The terms certification, accreditation, and credentialing are often used interchangeably when they apply to compounding-pharmacy qualifications, but they are not synonymous. The reasons for obtaining each, the requirements for each, and the benefi...
Pritchett J, McCrory G, Kraemer C et al. — International journal of pharmaceutical compounding
The Practice of Compounding, Associated Compounding Regulations, and the Impact on Dermatologists
Medication compounding gained national attention in the fall of 2012 after contaminated compounded medications produced in the New England Compounding Center infected 800 people with fungal meningitis and led to several fatalities. This prompted C...
Quertermous J, Desai S, Harper J et al. — Journal of drugs in dermatology : JDD
Microbiologic Testing for 503A Sterile-Compounding Pharmacies
Compounding pharmacists must ensure that the sterile preparations they dispense are free of microbiologic contamination. Working in a cleanroom under controlled conditions (proper differential air pressure, temperature, and humidity; acceptable le...
Mixon W, Roth A — International journal of pharmaceutical compounding