What is a Compounding Pharmacy?

  • Every patient is not created equally, therefore you have unique needs when it comes to your medications and we have the solutions. In a cookie-cutter world, we don’t believe in a one-size-fits-all approach to medication. Our foundations are built on providing the right solutions for your unique body chemistry.
  • 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. The preparations offered by these compounding pharmacies can be non-sterile (ointments, creams, liquids, or capsules that are used in areas of the body where absolute sterility is not necessary) or sterile (usually intended for the eye, or 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. With such tools and through applying their knowledge, all pharmacists routinely prepare non-sterile compounded preparations when requested by prescribers.
  • Of the approximately 56,000 community-based pharmacies in the United States, about 7,500 pharmacies specialize in compounding services, and of those, less than 80 FDA-approved. This means the pharmacists in those facilities spend most or all of their time compounding special preparations for patients. Preparations made in these pharmacies are more likely to include both sterile and non-sterile dosage forms. Compounding also takes place in hospital pharmacies and at other healthcare facilities.
medical compounding pharmacy
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FAQs

What forms are compounded medications available in?

We can compound medications in many forms, including:

  • Injectables
  • Capsules
  • Sublingual
  • Liquid
  • Topical
  • Cream
  • Gel
  • Tablets
  • Suppositories

What specialties use compounding medications?

Many specialties utilize compounding for more individualized patient care. Some of our specialties include:

Who regulates compounding pharmacies?

Do compounding pharmacies follow the same regulations as drug manufacturers? Why or why not?

The practice of compounding is regulated by state boards of pharmacy. Community and hospital compounding pharmacists are allowed exemptions to the Federal Food, Drug, and Cosmetic Act of 1938 if they comply with the regulations outlined in Section 503A. All pharmacists and pharmacies engaged in compounding are subject to oversight by both federal and state authorities.

Pharmacists engaged in compounding are expected to follow applicable standards and regulations for the types of preparations that are compounded. FDA has oversight for the integrity and safety of the drugs (called Active Pharmaceutical Ingredients, or APIs, by FDA) used in compounded preparations. The Drug Enforcement Administration (DEA) has oversight for any controlled substances used in the preparation of compounded medications. Controlled substances include narcotics such as hydrocodone, amphetamines, and similar drugs, and drugs such as those used for anxiety and sleep disorders.

In addition, the United States Pharmacopeial (USP) Convention issues standards that apply to compounding. This private, nonprofit organization defines the chemical purity of drugs and also issues practice standards. USP develops standards for the identity, quality, strength, and purity of medicines, dietary supplements, and food ingredients that may be used in compounding preparations. These standards, in particular, are relevant to compounding pharmacists.

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 non-sterile preparations that are compounded in healthcare 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.

USP General Chapter <800> is a new standard developed by USP that establishes practice and quality standards of hazardous drugs to minimize the exposure to hazardous drugs within healthcare settings. This standard aims to promote worker safety (pharmacists, pharmacy technicians, veterinarians, veterinary technicians, and many others), patient safety, and environmental protection. This standard was published on February 1, 2016, but will not be officially implemented until July 1, 2018. The current list of hazardous drugs is available from the National Institute for Occupational Safety and Health (NIOSH).

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

When is a compounding pharmacy necessary?

A healthcare provider will prescribe a compounded drug only when commercially available drug products do not meet your needs. If you do not understand why you have been prescribed a special formulation, ask your prescriber.  If you are concerned about taking a compounded drug and you and your prescriber agree that you can tolerate the commercially available drug, you may also ask if there is any evidence that your outcome will be better on the compounded formulation.

Does a compounding pharmacist have special training?

Compounding is a central activity in the practice of pharmacy. Pharmacists are taught in pharmacy school how to properly compound medications, and many states test pharmacists’ compounding knowledge and skills before issuing them a license. Pharmacists who practice in pharmacies that specialize in compounding services have generally had advanced training in compounding after they graduated from pharmacy school.

How would patients know if their medication is compounded?

Ask. A patient can receive compounded drugs from a typical community pharmacy or a specialty compounding pharmacy, or compounded drugs can be administered by doctors or other health professionals in clinics or medical offices. Patients should ask the person administering a medication or the pharmacist dispensing a prescription whether it was prepared in a compounding pharmacy or manufactured by a drug company. A widely accepted standard of practice is to label all compounded preparations with information stating the medication has been “compounded.”

If a prescription calls for a compounded drug, patients can ask whether the compounding pharmacy is accredited.

How is pharmaceutical compounding different from drug manufacturing?

Traditional compounding is the preparation of a medication to meet the prescriber’s 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 (see question below on legal oversight of compounding versus manufacturing). 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.