A legitimate compounding pharmacy service must meet the demands of government regulators, consumer needs, and public expectations of quality and safety. The FDA answers the question of what is a compounding pharmacy by defining it as “a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.”
The importance of this emphasis on competent and licensed compounding pharmacies performing this function is the black eye the specialty has received from stories about firms that had to recall many of their compounded drugs. WebMD reported how one company’s mistake led to 13,000 cases of meningitis, noting how New England Compounding Center (NECC) “recalled the 2,410 different drugs it sold in all 50 states. Fungal contamination of at least one product -- single-shot syringes filled with a steroid preparation -- is responsible for the meningitis outbreak.”
The issue of what is a compounding pharmacy has changed with the marketplace, due to the expansion in the functions of a compound pharmacy. David Miller, RPh, CEO of the International Academy of Compounding Pharmacists (IACP), the trade group representing the compounding industry, states: “In the last two to three years there has been an upsurge in an old function of compounding pharmacies, to step in on a local basis to fulfill drug shortage issues. What we have seen is on a large scale, important drugs being in shortage and not for short periods as before. Now it's in the months-to-years range. So compounding pharmacies are being looked to on a larger scale as we try to address drug manufacturing problems."
This need for expanded amounts of compounded drugs can lead to mistakes, as with the NECC case, making it much more critical for pharmacies to meet professional safety standards to keep pace with the higher supply expected from the industry. The need to generate larger supplied of drugs can lead to aninventory being generated that no longer is individual-based. The regulatory agents have therefore been observing the situation, says Wikipedia, ”based in part on growing concerns about "non-traditional" or non-patient-specific compounding - particularly of sterile injectable drug products. Traditional, patient-specific compounding remains essentially unaffected and continues to fall under the domain of state pharmacy practice regulation without controversy.”