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
FDA Finalizes Reclassification of Seven Compounded Peptides, April 2026
FDA finalized the reclassification of seven peptides previously available through 503A compounding pharmacies. BPC-157, TB-500, KPV, DSIP, Epitalon, LL-37, Selank, Semax, and Melanotan II are no longer eligible for traditional compounding. Advisory panel for remaining peptides scheduled July 2026.
Truthe take: This is the regulatory event we have been tracking since 2024. Some compounds in our protocols are affected. We have updated our formulary and our patients have been notified. The July panel will determine the next wave.
— FDA.gov
FDA-Approved Antibacterials and Echinocandins
Since 1955, a total of 12 peptide-based drugs with antimicrobial or antifungal properties have received approval from the Food and Drug Administration (FDA). Peptides present a promising opportunity to address serious infections that may be challe...
Al Musaimi O — Antibiotics (Basel, Switzerland)
Tissue-specific mRNA delivery and prime editing with peptide-ionizable lipid nanoparticles
Lipid nanoparticles for mRNA delivery and gene editing have the potential to transform the current therapeutic landscape. Nonetheless, a major bottleneck using this technology is the difficulty in achieving cell- and tissue-specific delivery and a...
Lin Y, Li M, Luo Z et al. — Nature materials
Natural Weight Loss or "Ozempic Face": Demystifying A Social Media Phenomenon
New patients turning to semaglutide (Ozempic® and Wegovy®), a glucagon-like-peptide 1 (GLP-1) agonist, for weight loss, have captivated social media platforms. Wegovy® carries a United States (US) Food and Drug Ad...
Carboni A, Woessner S, Martini O et al. — Journal of drugs in dermatology : JDD
Peptide-drug conjugates: A new paradigm for targeted cancer therapy
Peptide-drug conjugates (PDCs) are the new hope for targeted therapy after antibody-drug conjugates (ADCs). Compared with ADCs, the core advantages of PDCs are enhanced tissue penetration, easier chemical synthesis, and lower production costs. Two...
Wang M, Liu J, Xia M et al. — European journal of medicinal chemistry
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
Anti-Amyloid Therapies for Alzheimer's Disease and the Amyloid Cascade Hypothesis
Over the past 30 years, the majority of (pre)clinical efforts to find an effective therapy for Alzheimer's disease (AD) focused on clearing the β-amyloid peptide (Aβ) from the brain since, according to the amyloid cascade hypothesis, t...
Fedele E — International journal of molecular sciences
Peptide-drug conjugates (PDCs): a novel trend of research and development on targeted therapy, hype or hope?
Peptide-drug conjugates (PDCs) are the next generation of targeted therapeutics drug after antibody-drug conjugates (ADCs), with the core benefits of enhanced cellular permeability and improved drug selectivity. Two drugs are now approved for mark...
Fu C, Yu L, Miao Y et al. — Acta pharmaceutica Sinica. B
Peptide-based drug discovery: Current status and recent advances
The progressive development of peptides from reaction vessels to life-saving drugs via rigorous preclinical and clinical assessments is fascinating. Peptide therapeutics have gained momentum with the evolution of techniques in peptide chemistry, s...
Sharma K, Sharma KK, Sharma A et al. — Drug discovery today
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
Gastrointestinal Permeation Enhancers for the Development of Oral Peptide Pharmaceuticals
Recently, two oral-administered peptide pharmaceuticals, semaglutide and octreotide, have been developed and are considered as a breakthrough in peptide and protein drug delivery system development. In 2019, the Food and Drug Administration (FDA) ...
Kim JC, Park EJ, Na DH et al. — Pharmaceuticals (Basel, Switzerland)
Glucagon-like peptide-1 (GLP-1) receptor agonists and neuroinflammation: Implications for neurodegenerative disease treatment
Chronic, excessive neuroinflammation is a key feature of neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD). However, neuroinflammatory pathways have yet to be effectively targeted in clinical treatments for s...
Kopp KO, Glotfelty EJ, Li Y et al. — Pharmacological research
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
FDA-approved bone grafts and bone graft substitute devices in bone regeneration
To induce bone regeneration there is a complex cascade of growth factors. Growth factors such as recombinant BMP-2, BMP-7, and PDGF are FDA-approved therapies in bone regeneration. Although, BMP shows promising results as being an alternative to a...
Gillman CE, Jayasuriya AC — Materials science & engineering. C, Materials for biological applications
Prolactin-Releasing Peptide: Physiological and Pharmacological Properties
Prolactin-releasing peptide (PrRP) belongs to the large RF-amide neuropeptide family with a conserved Arg-Phe-amide motif at the C-terminus. PrRP plays a main role in the regulation of food intake and energy expenditure. This review focuses not on...
Pražienková V, Popelová A, Kuneš J et al. — International journal of molecular sciences
Battle of GLP-1 delivery technologies
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) belong to an important therapeutic class for treatment of type 2 diabetes. Six GLP-1 RAs, each utilizing a unique drug delivery strategy, are now approved by the Food and Drug Administration (F...
Yu M, Benjamin MM, Srinivasan S et al. — Advanced drug delivery reviews
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