Can pharmacies compound products for sale over-the-counter under a retail license?

The regulation surrounding compounding by pharmacies is quite specific, particularly when it comes to selling compounded products over-the-counter. In the case of Oregon, pharmacies are generally not permitted to compound products specifically for the purpose of retail sale. This restriction is in place to ensure that compounded products meet necessary safety and efficacy standards comparable to those of manufactured products, which have undergone rigorous testing and approval by the FDA.

Pharmacies can engage in compounding for individual patients based on a licensed prescriber’s prescription; however, the intention behind compounding must be for the purpose of serving the specific medical needs of those patients, rather than creating stock products intended to be sold to the general public. Compounding for over-the-counter sale doesn't align with the regulatory framework, which emphasizes patient-specific medications rather than general retail sales.

While there are instances when compounding is permissible for hospitals or specific patient needs, this does not apply to compounding for the retail market, limiting the scope of what pharmacies can manufacture and sell to ensure patient safety and compliance with the law. Therefore, pharmacies cannot compound products intended for over-the-counter sale under a retail license.