Which types of drugs are not classified as covered outpatient drugs?

Covered outpatient drugs under the $340B Program are defined primarily as those that are FDA-approved and prescribed for outpatient use. However, certain categories of drugs do not meet the criteria for being classified as covered outpatient drugs.

Drugs that are available as over-the-counter (OTC) medications are not included as covered outpatient drugs under the program. The rationale behind this is that OTC drugs are not typically dispensed with a prescription and the program specifically pertains to prescription medications that may be purchased at reduced prices.

While other choices might also seem relevant, they do not directly align with the definition of excluded drugs in the context of the $340B Program. For instance, drugs from retail pharmacies are often included as covered outpatient drugs as long as they meet the criteria set forth by the program. Specialty drugs may also qualify, provided they are prescribed and do not fall into an excluded category. On the other hand, the mention of drugs being cheaper on a Group Purchasing Organization (GPO) does not inherently disqualify them from being considered covered outpatient drugs; it simply refers to pricing.

Understanding the nuances of what constitutes a covered outpatient drug is key to navigating the complexities of the 340B Program effectively, particularly regarding compliance and ensuring eligibility for discounted pricing.