Labeling Regulations for Compounded Drugs

Empower Pharmacy is registered with the US Food and Drug Administration (FDA) as a 503B outsourcing facility under the recently enacted Drug Quality and Security Act (DQSA). The law, signed by the President on November 27, 2013, calls for entities engaged in office use anticipatory compounding to register with the FDA under the newly created section 503B.

Empower Pharmacy's registration as an outsourcing facility under the DQSA is based on draft guidance released by the FDA and listed in the Federal Register on December 4, 2013. Apart from new drug labeling and drug event reporting regulations, Section 503B also requires outsourcing facilities to compound all drugs utilizing current good manufacturing practices (cGMP), the same standards large pharmaceutical manufacturers use. Empower Pharmacy is actively engaged in complying with all requirements defined in the DQSA.

Part of this compliance strategy entailed a complete label redesign for our products to help enhance patient safety. In accordance with the DQSA, label changes or additions will include: The statement “compounded drug”, the name, address, and phone number of our outsourcing facility, the lot number of the compound, the established name of drug, the dosage form and strength, the statement of quantity or volume, the date that the drug was compounded, the beyond use date, the storage and handling instructions, the statement “not for resale” or “office use only” where applicable, and a list of active and inactive ingredients identified by established name and the quantity or proportion of each ingredient.

With respect to the container from which individual units are removed for dispensing or for administration Empower Pharmacy includes: information to facilitate adverse event reporting, and directions for use, including the appropriate dosage and route of administration.

Packaging of sterile drugs must be appropriate to the product and capable of ensuring the sterility and integrity of the product until it is administered to a patient. Packaging and labeling are critical to ensure the quality of compounded sterile drug products. We ensure through closure integrity testing that our container, closure, and packaging systems provide adequate protection against external factors in storage, shipment, and use that could cause contamination or deterioration of the finished product. Our labeling operations include adequate controls that have been established for issuing labels, examining issued labels, and reconciliation of used labels to prevent mix-ups. All labeled drug products are examined for accuracy and thoroughness before release.