Why BodMD Partners with Compounding Pharmacies

BodMD has partnered with compounding pharmacies to deliver the highest quality medications specially made for you.  Through clinical research, BodMD has created compounded therapies along with expert pharmacists that are not commercially manufactured.

 

Definition of compounding: Per U.S. Pharmacopea Convention (USP), compounding is 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

Why BodMD partners with a compounding pharmacist to customize medications based upon a doctor’s prescription for a patient’s needs:

  • Strength or Dosage can be customized
  • Flavors can be added
  • Reformulate to exclude an unwanted, nonessential ingredients such as lactose, gluten, or a dye to which a patient is allergic
  • Application of the medication for patients in transdermal, sublingual, tablets, capsules, etc.

How is pharmaceutical compounding different from drug manufacturing?

Traditional compounding is the preparation of a medication to meet BodMD prescribers’ exact specifications and to be dispensed directly to the patient, pursuant to a valid prescription for that patient. Pharmaceutical compounding is performed or supervised by a pharmacist licensed by a State Board of Pharmacy. (Each state has their own Board of Pharmacy, by the way.)

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 practitioners, or others who are authorized under state and federal law to resell them.

What is a compounding pharmacy?

While most pharmacies offer some level of compounding, most compounding is done in pharmacies that have made the investment in equipment and training to do so safely and efficiently. For BodMD therapies, pharmacies create nonsterile (ointments, creams, liquids, or capsules that are used in areas of the body) or sterile (usually injection into body tissues or the blood).

All licensed pharmacists learn during their training and education to perform basic compounding. In addition, most pharmacies have some compounding tools, such as a mortar and pestle for grinding materials, graduated cylinders for measuring liquids, balances for weighing solids, spatulas for mixing materials, and ointment slabs on which to work.

Who regulates compounding pharmacies?

We mentioned the act of compounding is regulated by State Boards of Pharmacy.  Compounding pharmacies are also regulated on a federal level.  Pharmacists are expected to follow applicable standards and regulations for the types of preparations that are compounded.  The FDA has oversight for the integrity and safety of the drugs (called Active Pharmaceutical Ingredients, or APIs) used in compounded preparations.  The  Drug Enforcement Adminsitration (DEA) has oversight for any controlled substances used in the preparation of compounded medications.

In addition, the US. Pharacopeial Convention (USP) creates standards for compounding. This private, nonprofit organization defines the chemical purity of drugs and also issues practice standards.

USP General Chapter <797> is a national standard for the process, testing, and verification of any compounded sterile preparations. It provides guidance on preventing microbial contamination and other variances in compounded sterile preparations, regardless of setting (e.g., hospitals, community pharmacies) or who is performing the compounding (pharmacists, nurses, pharmacy technicians, or others).

USP General Chapter <795> provides similar guidance for nonsterile preparations that are compounded in health care settings. It describes categories of compounding (simple, moderate, complex), defines concepts such as beyond-use date and stability, and provides criteria for compounding pharmacists to follow in preparing various drug preparations.

 

Compliance with these and other USP guidelines is considered the minimum standard of practice in pharmacy.