FDA GUIDANCE DOCUMENT

Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Part 2

FEBRUARY 2023

IMMEDIATELY IN EFFECT

I. INTRODUCTION (Discussed in a previous newsletter.)

II. BACKGROUND

FDA is aware of reports from hospitals, health systems, and State-licensed pharmacies that they have experienced difficulties obtaining certain FDA-approved ibuprofen oral suspension drug products used for fever and pain treatment of pediatric patients and adults who are unable to swallow solid oral dosage forms. FDA is closely monitoring this situation and using all of its applicable authorities to work with the manufacturers of approved ibuprofen oral suspension drug products to increase supply. However, we recognize that hospitals, health systems, State licensed pharmacies, and applicable Federal facilities have concerns about assuring access to these drug products to use for fever and pain treatment of pediatric patients, and adults who are unable to swallow solid oral dosage form products, during the winter months when respiratory illnesses are likely to be elevated. Therefore, FDA is issuing this policy to provide temporary flexibility to help ensure that treatment options are available when hospitals, health systems, State-licensed pharmacies, and applicable Federal facilities are unable to obtain ibuprofen oral suspension drug products to use for fever and pain treatment of pediatric patients and adults who are unable to swallow solid oral dosage form products. This guidance addresses ibuprofen oral suspension products compounded by outsourcing facilities and provided to: 1) hospitals and health systems for administration within the hospital or health-system; 2) State-licensed pharmacies (including those within hospitals and health systems), and applicable Federal facilities to dispense to patients for use at home after receiving a valid, patient-specific prescription. Fever and pain reducing oral suspension products are needed in the hospital and health system setting to treat patients with acute needs and also in the home setting for appropriate treatment of children as well as for adults who are unable to swallow solid oral dosage forms. The availability of ibuprofen oral suspensions for use in homes may help to prevent patients from seeking care in hospitals and health systems when such care is not otherwise needed, which could cause unnecessary strain on hospitals and health systems.

Fever and pain reducing oral suspensions, such as ibuprofen oral suspensions, are important in the management of pediatric patients who may require more specific weight-based dosing and adult patients who cannot swallow solid oral dosage form products. Fever can make patients uncomfortable and is associated with increased metabolic rate, oxygen consumption, carbon dioxide production, and demands on the cardiovascular and pulmonary systems. In certain vulnerable populations, untreated high fever could lead to potentially serious or life-threatening situations.

Although compounded drugs can serve an important patient need, they can also pose a higher risk to patients than FDA-approved drugs. Compounded drug products are not FDA-approved, which means they have not undergone FDA premarket review for safety, effectiveness, and quality. Because compounded drug products are subject to a lower regulatory standard, the agency recommends FDA-approved drugs be used to treat patients whenever possible.

Additionally, in 2022 and 2023, FDA received reports of pediatric medication contaminated with diethylene glycol (DEG) and ethylene glycol (EG) in several countries. DEG and EG are toxic to humans when consumed and can be fatal. Toxic effects can include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death. Although none of the 2022 reports were regarding products in the United States, DEG and EG contamination has been identified in past reports in the United States and remains a significant quality consideration for oral suspensions compounded using components at higher risk of contamination with DEG and EG.

The policies in this guidance are intended to balance access concerns with risks associated with compounded drug products and particularly with compounded oral suspension products.

For the most recent version of the guidance, check the FDA guidance web page at:
https://www.fda.gov/​regulatory-​information/​search-​fda-​guidance-​documents.

Next week's newsletter will cover the "Discussion" on this topic.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition