Injectable products are a type of pharmaceutical formulation designed to be administered directly into the body through a needle. Unlike oral medications, which pass through the digestive system, injectables are delivered through methods such as intravenous (IV), intramuscular (IM), or subcutaneous (SC) injections. This approach allows the medication to bypass the digestive tract, enabling faster and often more effective delivery, especially for drugs that are not well-absorbed orally or require immediate action.
Injectable products typically include solutions, suspensions, and emulsions. These products are often prepared as sterile formulations in vials, prefilled syringes, ampoules, etc., to ensure the highest standards of cleanliness and safety, given the risk of infection or contamination upon entering the body directly. They can range from vaccines, hormones, and antibiotics to specialized treatments for chronic conditions like diabetes (insulin) and autoimmune disorders (biologics).
Due to their direct administration into the body, injectable products undergo rigorous quality control and are subject to strict regulatory guidelines. Each product is inspected meticulously for sterility, particulate matter, and other potential defects. Quality control teams often rely on visual inspection and specialized testing methods to ensure that each dose is safe and effective for patient use.
Applicability/Regulatory Definitions:
- Injectable human drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
- Injectable animal drugs approved under section 512 or 571 of the Federal Food, Drug, and Cosmetic Act. (FD&C Act)
- Injectable biological products licensed under section 351 of the Public Health Service Act (PHS Act)
- Injectable drug or biological products that are considered combination products under 21 Code of Federal Regulations Part 3. (21 CFR Part 3)
