Compounding Pharmacies: Who is in Charge?

Abstract

Compounding pharmacies play an increasing and increasingly important role in our healthcare system, but recent media attention has exposed limited regulatory control over these organizations at the same time their role is expanding. Compounding pharmacies are not regulated in the same manner as pharmaceutical companies and are governed largely by Chapter <797>, a monograph on the pharmaceutical compounding of sterile products, issued but not enforced by the U.S. Pharmacopeial Convention. Not all states require adherence to Chapter <797>, and those that do may choose not to enforce it stringently. Furthermore, Chapter <797> is not a strong standard--for example, it does not require documentation of drug lot numbers or cross-references for patient identification. Thus, there have long been many potential quality issues associated with compounding pharmacies. As these compounding pharmacies provide important products and services, better regulation is urgently needed. Moreover, clinicians should be better aware that some injectable products they use may have been prepared by a compounding pharmacy.

Factors to consider in developing individual pharmaceutical product quality risk profiles useful to government procurement agencies

“…Four classes of recalled products from the original list were excluded before further analyses as the reason for recall was not specific to the product but rather general in nature. Compounded products were also excluded as these are not produced by conventional commercial manufacturing 23 , 24 , 25 and would not or should not be used as sources for EML procurement.…”

Scientific and technological connections between specialists in injectable oncology: a contribution to public health from the analysis of the Lattes database

“…The handling of injectable drugs is an activity of great importance and complexity developed by the pharmaceutical sector, since these drugs are not commercially available, with the possibility of customizing the preparation to meet the specific needs of the patient: individualization of the dose, adequacy of the formulation to the route of administration, adding components to the formulation and choosing the type of diluent volume appropriate to the patient's clinical condition (ASHP, 2014;Mohiuddin, 2020;Pergolizzi Jr et al, 2013). One of the great challenges of chemotherapy is the selective delivery of drugs to tumour cells with minimal interaction with healthy tissues (Webster et al, 2014) In recent decades, due to the enormous amount of information constantly generated in the most diverse contexts of society, information has come to be classified as a strategic resource with price, cost and value (Valentim et al, 2006).…”

Information mining in patent filings on injectable antineoplastics as a contribution to Health Policy

“…However, the difficulty is based on the fact that they can impair and also improve the acquisition and retention of learned responses in the organism in which it was administered (McGaugh 1973). These drugs are not commercially available, with the possibility of personalizing the preparation to meet the specific needs of the patient: individualization of the dose, adaptation of the formulation to the route of administration, adding components to the formulation and choosing the type of diluent volume suitable for the patient's clinical condition ("ASHP Guidelines on Compounding Sterile Preparations", 2014; Mohiuddin, 2020;Pergolizzi Jr et al, 2013). Regarding the handling of antineoplastic drugs, their correct handling is essential to ensure success in the treatment of cancer patients, as any error in dosage can lead to irreversible damage (ABRALE, 2020).…”