Exhibit 2. Why Is Off-Label Use of Drugs in Children Still a Problem? [13].

Lack of specifications required for component development by compounding pharmacies. No onsite testing of active ingredients and excipients for purity, potency, content and stability. No onsite specifications or testing of product containers and closures. Site-to-site variations in compounding procedures, equipment, and the degree of product handling/manipulation. Lack of environmental control, which might lead to unintentional contamination and generation of degradation products due to inconsistent exposure to light, temperature and processing controls. Lack of testing of finished products for purity, potency, content or stability. Stability data for establishing expiry dates of compounded products are derived from published data, where preparation methods likely vary from local methods, or are simply default expiry periods defined by regional pharmacy regulations and “best practices”. Published preparation methods provide only a portion of the information needed to consistently prepare a stable potent final product. Limited options available to mask bad-tasting active ingredients. The dose administration technologies used such as droppers, syringes, scoops, spoons, etc., vary between sites and between prescription fills. Weak regulatory oversight.