Compounding pharmacies play a vital role in the American healthcare system by filling gap in the drug supply chain that would otherwise go unmet.
Drug compounding is critical to ensuring all patients have access to safe medicine.
Sensible regulation and enforcement of compounding is essential to protecting the public while protecting the integrity of the practice and helping to ensure the sustainability of responsible compounding pharmacies.
Industry standards and self-regulation must play an integral role in promoting sensible regulation and enforcement and ensuring sustained access to compounded medicines.
We are compounding pharmacies and health professionals committed to promoting safe and responsible compounding practices to and protecting access to safe compounded drugs.
Get in TouchCompounding pharmacies provide a vital service to patients in need of specialized formulations, dosing, or means of administration, and those needing access to medicine unavailable as manufactured pharmaceuticals.
Compounded drugs are created using the compounding standards articulated by the US Pharmacopeia, from pure bulk ingredients by professionals licensed by state boards of pharmacy, and subject to regulation and inspection by the Food and Drug Administration (FDA), as well as the boards of pharmacy of the state in which these licensed professionals reside.
Under federal law (Section 503A), to be eligible for use in a compounded product, an active ingredient must:
In September 2023, FDA updated the List of Bulk Drug Substances adding several peptides to category 2 because the agency “... identified significant safety risks. FDA can take regulatory action against pharmacies using category 2 substances and other substances that do not otherwise eligible as an ingredient in a compounded drug product.
Compounding plays a vital role in providing patients with safe and effective drugs, including medicines for rare diseases and conditions not available through pharmaceutical manufacturers. Drug compounding, or compounding, is the process by which...
Growth hormone has been touted as fountain of youth and virility by the antiaging community. Many of these drugs used in “peptide therapy” present a serious and potentially deadly risk to individuals living with, or predisposed to, cancer. Growth...
