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How to Evaluate a Compounding Pharmacy

Compounding pharmacies are regulated by individual state boards of pharmacy. Depending on the state there are varying degrees of oversight on compounding practices. That being said, pharmacies that have good procedures, top of the line equipment, and continual quality control can prepare a compounded medication that rivals a mass produced pharmaceutical in its potency and purity.

When choosing a compounding pharmacy, it is extremely important to consider the following items before having your prescriptions filled.

What is the source of the pharmaceutical ingredients/chemicals?

The chemicals used to make compounds should be sourced from FDA approved chemical manufacturers and distributors.

Patterson Park Pharmacy only sources its chemicals from facilities that are licensed by the FDA as a chemical supplier. Patterson Park pharmacy requires a Certificates of Analysis for every chemical in the pharmacy. The formulas used to compound customized medications are adjusted based on the results of the Certificate of Analyses. Every formulation we make has the record of each and every active pharmaceutical ingredient (API) with a complete tracking of the chemical’s source.

What kind of equipment is used?

Using the right equipment in a proper manner is the key to receiving expected results. To ensure the proper use of the specialized compounding equipment, Standard Operating Procedures (SOPs) must be in place to standardize the process.

Patterson Park Pharmacy uses the most advanced technology in the compounding industry, including ointment mills and homogenizers for creams and acoustic resonant mixers for the dry ingredients that fill capsules. We have a cream and ointment filler, electronic pH meters, electronic hot plates and more.

Patterson Park Pharmacy only sources its chemicals from facilities that are licensed by the FDA as a chemical supplier. Patterson Park pharmacy requires Certificates of Analysis for every chemical in the pharmacy. The formulas used to compound customized medications are adjusted based on the results of the Certificate of Analysis. Every formulation we make has the record of each and every active pharmaceutical ingredient (API) with a complete tracking of the chemical’s source.

Does the pharmacist have a relationship with my doctor, and if not, is the pharmacist willing to forge a relationship with him or her?

Compounded prescriptions require a much higher level of communication between the pharmacist and the prescriber than conventional medications do. A good, open communication between your pharmacist and prescriber will help ensure that you are receiving the appropriate medication in the appropriate way.

At Patterson Park Pharmacy a highly trained staff member is just a phone call away. We launched a separate department to achieve effective communication between prescribers and patients. We offer detailing service for our prescribers where we improve the understanding of custom medication process by using facts and data. We have library of authentic research articles and journals which can be accessed by prescribers on demand. Every pharmacy personnel working in compounding department receives special training in the concepts and protocols of compounding.

Does the pharmacy have its compounded medications sent to an independent lab to be tested?

This is called “skip-lot testing” and allows a compounding pharmacy to know if their compounded preparations are created properly and contain the drugs in the proper concentrations.

“What’s not measured cannot be managed”. When it comes to this statement, we are true believers. Patterson Park Pharmacy uses an independent lab to evaluate the potency and accuracy of its formulations. By independent testing we are able to identify the strength of our formulations, how consistent are we across the board and if there is any contamination. The samples to be tested are selected randomly by the software and are sent to the lab. Every technician who is involved in the process of compounding in the lab has to have his/her sample evaluated.

What quality control measures are observed?

It is imperative that a compounding pharmacy employ and adhere to strict quality control measures. Commonly called Continuing Quality improvement (CQI) programs are procedures and protocols to document and monitor quality related events.

At Patterson Park Pharmacy every chemical on our shelf is bar coded. Every chemical has to be scanned and verified before the weighing process begins. The weighing balances are connected to the software which records the weight of the chemical to be used. If the weight is out of acceptable limits then the software warns the user and puts a halt to the process. Every formula has a written protocol of manufacturing, which is followed for every preparation. Each batch is tagged with a unique lot number; the records are kept in electronic and hard copy files. Any issue related to quality, safety, consistency and service is recorded and a variance reported is generated. A variance report can be as simple as a patient not receiving a compound at a promised time or as complex as having a serious side effect. The variance reports are discussed in our monthly staff meeting where solutions are determined and corrective actions placed.

Is the pharmacy accredited?

The body that accredits pharmacies is called the Pharmacy Compounding Accreditation Board (PCAB). PCAB Accreditation is a voluntary program for compounding pharmacies. Pharmacies who have achieved PCAB Accreditation show their commitment to providing the highest quality compounded medications for their patients. You can learn more about them at http://www.pcab.info.

Patterson Park Pharmacy is accredited by the PCAB and a proud member of the Professional Compounding Centers of America (PCCA) and the International Academy of Compounding Pharmacies (IACP). All of our policies and procedures are derived from United States Pharmacopeia (USP).

Find out more about important health information and special events at Patterson Park Pharmacy.

Professional Affiliations

PCAB UCM PCCA IACP ACA Epic Mpha