GMPs include provisions for the facilities and equipment used to manufacture drugs, the education and training of personnel, and the Napabucasin nmr calibration and cleaning of process equipment. Validated analytical test procedures are used to ensure that drugs

conform to FDA-approved specifications for potency, purity, and other requirements such as sterility. All incoming ingredients and components must be retested upon receipt, and manufacturing processes must be validated to consistently meet quality standards. GMPs also require an independent quality control unit to oversee the manufacturing, packaging, and testing processes and to reject substandard batches. Stability studies must be performed to support expiration dating of products. 3 Pharmacy Compounding 3.1 Traditional Pharmacy Compounding The FDA defines traditional pharmacy compounding as the Epigenetics inhibitor combining, mixing, or altering of ingredients to create a customized medication for an individual patient in response to a licensed practitioner’s prescription [1]. The National Association of Boards of Pharmacy (NABP) further describes compounding as the result of a practitioner’s prescription drug order based on the practitioner/patient/pharmacist relationship in the course of professional

practice [7]. Traditional pharmacy compounding plays a valuable role in providing access to medications for individuals with unique medical needs, which cannot be met with a commercially available product. For instance, a prescriber may request that a pharmacist compound SPTLC1 a suspension for a pediatric or geriatric patient unable to swallow a medication in its commercially available form. In traditional pharmacy compounding, an individualized medicine is prepared at the request of a prescriber on a small scale. 3.2 Non-Traditional Pharmacy Compounding Some pharmacies have seized upon a burgeoning business opportunity to expand their activities beyond the scope of traditional pharmacy compounding [8]. Examples of improper

pharmacy compounding include introducing drug moieties that have not been approved for use in the US or have been removed by the FDA for safety reasons, large-scale production of compounded medications without prescriptions, and creating copies (or essentially copies) of FDA-approved drugs. The FDA issued PF-3084014 cell line letters in 2004 to compounding pharmacies obtaining domperidone from foreign sources for women to assist with lactation, noting that domperidone is not approved in the US for any indication. Citing public health risks, including cardiac arrest and sudden death, the FDA recommended that breastfeeding women avoid the use of domperidone [9]. The FDA has publically expressed concerns regarding “large-scale drug manufacturing under the guise of pharmacy compounding” [1, 2].