Manufacturing vs Compounding

Manufacturing is the mass production of drug products that have been approved by the Food and Drug Administration (FDA). These products are sold to pharmacies, health care providers, and others authorized by the law to resell them. Manufacturing involves the production of such medications, based on a set formula, at a set dose or dosages, and with the use of excipients or additives chosen by the manufacturing company.

The U.S. Pharmacopeia Convention (USP) formally defines compounding as “the preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner/patient/ pharmacist/compounder relationship in the course of professional practice.”

FDA’s Compounding FAQ further defines compounding as when 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.”

Regular retail and chain pharmacies usually sell only conventional manufactured medications. These conventional meds are made by huge manufacturing companies (usually referred to as “Big Pharma”). They contain the active ingredient (+/- 10%) and any inactive ingredients they desire. Greater than 99% of all generics are made outside the USA. A recent recall of a class of medications known as Angiotensin Receptor Blockers (ARB) was found to be contaminated with a cancer causing excipient. Over 30 million patients were affected and in our pharmacy we were constantly scrambling to find alternatives and removing recalled lots from many different manufacturers.

The other alternative is compounding pharmacies. MayaScript is a traditional compounding pharmacy. In other words, Compounding is the preparation of a “custom-made” medication to provide a single patient with a pharmaceutical product that is customized to fit his/her unique needs. Compounding takes place upon the receipt of a prescription for a single patient and for that patient alone, following strict USP safety procedures, and using bulk ingredients acquired from FDA approved and regulated facilities.

To complicate matters, now we have large compounding pharmacies that act like manufacturers. They provide wholesale compounded medications to physician offices, veterinary offices even other pharmacies for resale. We are fiercely independent and do not wholesale any compounded medications. We are not members of any compounding supplier that requires us to buy exclusively from them. We source all of our ingredients from reputable and FDA licensed suppliers. We compound each prescription individually one at a time.

We firmly believe that you the patient and consumer, who usually pays cash for the entire compounded prescription, have the right to have it filled at the compounding pharmacy of your choice.

MAYACCURATE SYSTEM

Some prescriptions for narrow therapeutic range drugs like thyroid preparations, are handmade and weighed to +/- 1% accuracy. This 10 times more accurate than is required. This is our exclusive MayAccurate system. Why? Because years ago, the State of Florida had a law that you could not substitute narrow therapeutic range medications. This negative formulary law mandated that only brand name medications be used to ensure consistent manufacturing from one source. So prescriptions written for Synthroid had to be filled ONLY with brand name Synthroid. This law has been removed and now Synthroid prescriptions can be filled with any generic levothyroxine that the pharmacy chooses.

MayaScript patients can expect their compounds to be made with that increased accuracy and with the same inactive ingredients each and every time it is filled with us.

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