Overview of Compounding Pharmacy | Cecilia Pham, PharmD | RxEconsult

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Overview of Compounding Pharmacy Category: Pharmacy by - December 1, 2012 | Views: 17313 | Likes: 1 | Comment: 0  

What are compounding pharmacies

This is a specific area of practice where pharmacists customize medications for individual patients by mixing raw ingredients. Pharmacists, as directed by a physician customize the strengths and dosage forms of a medication. This makes it easier for patients to take their medication which improves treatment.

How many compounding pharmacies are there in the country

There are approximately 56,000 community-based compounding pharmacies in the United States of which half serve local health providers and patients. 7,500 compounding pharmacies provide advanced compounding services and 3,000 of these also practice sterile compounding.

How are compounding pharmacies different from other pharmacies

Many regular pharmacies only dispense drugs in fixed dosages, strengths, and routes provided by the manufacturers. Compounding pharmacies can change the dosages, strengths, and routes that are not available in commercial products. For example:

  • They can make combination skin products unavailable from the manufacturer.
  • Specific inactive ingredients in commercial products that some patients may be allergic to could be removed or replaced in a compounded product.
  • Tablets can be converted to liquid solutions or suspensions.
  • Medications with adult dosages can be diluted into dosage strengths for children and elderly patients.
  • They can compound drugs during commercial product shortages.
  • They can make sterile drugs.

Because compounding pharmacies mix different ingredients to make one product, most of the medications will have shorter expiration dates than commercial products.

What types of medications are frequently compounded

Here are the types of medications:

  • Animal medicines
  • Children's medications
  • Dentistry products
  • Eye drops
  • Ear drops
  • Infertility drugs
  • Skin products
  • Sports medicines
  • Flavoring medications
  • Gastrointestinal products
  • Pain management drug
  • Hormone replacement therapy
  • Anti-aging/cosmetic products

What are examples of drugs that are compounded

The most common drugs compounded are topical preparations (e.g., creams, lotions, ointments, suppositories, and pastes) and liquids for oral administration (e.g., elixirs, syrups, and suspensions). Examples of specific medications that are commonly made in compounding pharmacies are:

  • Hormones - DHEA, testosterone, estrogen, and progesterone
  • Pain and numbing medications (e.g., magic mouthwash, morphine sulfate, atropine, ABHR, phenobarbital, phenytoin, haloperidol, lorazepam, chloral hydrate, pain gels)
  • Steroids and thyroid disease compounds
  • Lansoprazole and omeprazole suspensions
  • Verapamil and nitroglycerin ointments
  • Enalapril and spironolactone suspensions
  • Ketoconazole/spironolactone/estradiol and clobetasol scalp solutions
  • Glutamine, lysine, and ornithine; aminobenzoic acid
  • Ursodiol
  • Boric acid suppositories
  • Antibiotics and antifungals
  • Meat or vegetable flavored medications for pets

How are compounding pharmacies regulated

Since many compounded products are tailored to a specific patient, they do not always require the Food and Drug Administration’s (FDA) approval. Like other pharmacies, compounding pharmacies and pharmacists are licensed and regulated by the State Boards of Pharmacy (SBOP). The Drug Enforcement Administration (DEA) regulates the handling of controlled substances. Standards of practice are set by the United States Pharmacopeia (USP) and the Pharmacy Compounding Accreditation Board (PCAB). Air quality, sterility-testing products, and training and testing of personnel in aseptic technique are examples of standards that are enforced. Contamination of sterile products can cause harm to patients; regulation and inspection is key in preventing such events. The ingredients for compounding medications are from FDA-registered and inspected facilities like the Professional Compounding Centers of America (PCCA).

What are best practices and standards for compounding pharmacies

Compounding pharmacists must follow state and federal compounding laws, regulations, and guidelines. This ensures that medications dispensed to patients are safe to use and quality is maintained. Best practices and standards include:

  • Continual updates and competency in the knowledge of medicine and practice
  • Having accredited licenses and certifications
  • Adequate training on compounding for all the staff such as product and equipment handling
  • Ensuring clean and safe compounding performance to prevent contamination and harm especially with sterile preparations such as using needles and syringes
  • Adequate supply of compounding equipment
  • Adequate supply of ingredients that meet the criteria of regulators like the FDA
  • Maintaining a clean work environment (e.g., clean surfaces, appropriate environmental temperatures; having gloves, smocks, goggles, masks)
  • Having proper protocol for ensuring purity and sterility of the facility and products compounding such as detailed product labeling like ingredient lists, lot numbers, expiration dates, storage, temperature logs, and cleaning schedule logs)
  • Any other paperwork and documentation for almost anything pharmacy related or required by laws and regulations
  • Complying with common audits, inspections, evaluations, and accurate reports to specific regulators to show evidence of proper and safe compounding

If even one of these standards are not properly followed or enforced in the pharmacy, problems may occur posing dangerous risks to patients. A recent example occurred in 2012. There was a fungal meningitis outbreak in people who used contaminated epidural steroid products that were compounded by the New England Compounding Center (NECC) in Framingham, Massachusetts. This resulted in the shutdown of the company and massive recalls in their products as well as from their sister company, Ameridose. Interesting questions arose such as faulty regulation and if there were actual adoption of specific standards by NECC. The FDA and lawmakers are discussing new plans to prevent similar future incidents. Proposals like the Verifying and Legality In Drug (VALID) Compounding Act about giving more regulating power to the FDA has been brought up to legislation. Discussion about creating more federal regulations for larger grand-scale compounding pharmacies have also been brought up. There were also suggestions of required standards, guidelines, and accreditation for all compounding pharmacies.

Despite these recent news, compounding pharmacies are still an essential need in healthcare. Not all drugs can be supplied by commercial manufacturers. Patients should not be discouraged from using compounding pharmacies. If patients have more questions, they should discuss them with their healthcare provider.


Board of Pharmacy California Code of Regulations. Repeal Section 1716.2. Record Requirements. Compounding for Future Furnishing.

U.S. Pharmacopeia. Good Compounding Practices. USP29.

Professional Compounding of America (PCCA).

International Academy of Compounding Pharmacists (IACP).

Pharmacy Compounding Accreditation Board (PCAB).

This medication summary is for information only and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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