Indian hospital pharmacies underscore US FDA norms on drug compounding at medical centres

Bengaluru, October 20, 2021:

Indian hospital pharmacies give greater emphasis to the presence of pharmacists in drug dispensing over compounding. Yet, a few hospital-attached pharmacies are engaged in compounding under the supervision of pharmacy and medical experts. US FDA now highlights the importance of Hospital and Health System Compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act.

Pharmacies located within a hospital, or standalone pharmacies that are part of a health system, frequently provide compounded drug products for administration within the hospital. Some of these compounders seek to compound drugs under section 503A. The guidance describes how FDA intends to apply certain provisions of section 503A to human drug products that are compounded by state-licensed pharmacies that are not outsourcing facilities for distribution within a hospital. 

According to US FDA, compounded drug products play an important role for patients in hospitals whose medical needs cannot be met by an FDA-approved drug product. This is because patient has an allergy and needs a medication to be made without a certain dye, or a geriatric or pediatric unable to swallow a pill and needs it as a syrup which is otherwise available.

First the guidance addresses the requirement that compounding be based on the  receipt of a valid prescription order for an identified individual patient. Second, it addresses the provision concerning compounded drug are essentially copies of a commercially available drug product. Many hospital pharmacies routinely compound oral liquids from tablets or other dosage forms for pediatrics. Although compounded drugs are important, they pose a higher risk to patients than FDA-approved drugs. In addition, compounded drugs are not FDA-approved, which it has no regulatory premarket review for safety, effectiveness, and quality. For these reasons, compounded drugs should only be used when an FDA approved product is not available to meet the medical needs of an individual patient.

Dr K Mruthanjaya, incharge, drugs centre, JSS Hospital and professor, JSS College of Pharmacy told Pharmabiz, “There is no compounding of drugs as such in India. Even in the US, compounding of medicines means dose calculation based on body mass index (BMI). In the past, India was known for compounders who worked with registered medical practitioners and compounded medicines which is now obsolete. The current practice is that whatever dose is prescribed is administered because drugs are manufactured in the required dosage form.

However, at the 1800-bed JSS Hospital, Mysuru, the JSS College of Pharmacy, department of hospital pharmacy, students who practice at this attached hospital are guided by a team of experts to update drugs by mixing and weighing to be provided in required dosages to cancer patients or in NICU. Some anti-cancer drugs in powder form are weighed and administered for particular person of low weight. For NICU, we prepare protein or amino acid mix and administered to newborns, said Dr Mruthanjaya.

This guidance according to US FDA has been drafted to stall untoward adverse drug reactions (ADRs). Since the 2012 fungal meningitis outbreak, FDA investigated ADRs  including fatalities associated with compounded drug products that were contaminated or unsafe. In 2017, it received AERs concerning patients for eye injections of a compounded drug during cataract surgery who later experienced vision impairment. FDA’s investigation revealed presence of an excipient in an amount that was much greater than what is found in FDA-approved ophthalmic products. Again in 2019, it received a report of an injectable drug product compounded with L glutathione manifesting ADR. The global regulator’s testing confirmed this and insisted compounding pharmacy drugs to be labeled as ‘Caution: Dietary Supplement’. PharmaBiz