Quality Assurance & Compounding

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The following is a summary of our operations and procurement and quality control processes. We are committed to complying with applicable laws and regulations and to ensuring high quality care for our patients.

Max Drugs Pharmacy operates as a compounding pharmacy in the State of Florida. Traditionally, the Food and Drug Administration (FDA) regulates the manufacture of drugs and the State Boards of Pharmacy regulates the practice of pharmacy compounding. Compounding differs from manufacturing in that compounded medication is prepared and dispensed pursuant to a valid prescription order from a physician for a specific patient. Manufactured drugs are mass-marketed, distributed through wholesalers, and eventually dispensed through pharmacies to patients unknown to the manufacturer.

Questions to Ask Your Compounding Pharmacy Max Drugs Pharmacy
USP <1075> 1 Are you committed to USP <1075>, Good Compounding Practices? Check
USP <795> 1 Are you committed to USP <795>, Pharmaceutical Compounding-Nonsterile Preparations? Check
2 Do you have a checklist, a process, and a review process in place for acceptable strength, quality and purity? Some of these questions may require thought and even investigation, such as those related to local or systemic absorption. Check
3 Does your staff take steps to minimize error and maximize the prescriber’s intent for the patient during the compounding process? Are these steps covered in your standard operating procedures and are they good practice standards to follow? Check
4 Do your compounding records and documents contain the sources and lot numbers of the ingredients, calculations, processes used, results of any testing done, an assigned beyond-use date, identification numbers, name of the compounder, quantity of the preparation compounded, and other pertinent information?. Check
5 Do you check to verify/insure that all the processes are appropriate and accurately performed? Check
6 As with any prescription, patient counseling is important. It is especially important with compounded preparations where the beyond-use date may be rather short. Do you counsel patients about use, storage and evidence of instability (visual changes, odor, etc.)? Check
USP <797> 1 Are you committed to compliance with the USP <797> guidelines for sterile compounding? Check
2 Do you have a checklist, a process, and a review process in place for acceptable strength, quality and purity? Some of these questions may require thought and even investigation, such as those related to local or systemic absorption. Check
3 Would you know if you are having a problem with your clean-room or aseptic compounding environment? Check
4 If you are compounding sterile preparations, do you conduct semi-annual independent lab tests of air and surface samples in your clean-room and other controlled environments? Check
5 Is the air quality in your general compounding lab engineered for HEPA filtration to reduce particulates? Check
6 Do you obtain independent, routine certifications of your clean-rooms and laminar airflow hoods? Check
7 Do you perform daily monitoring and documentation of your clean-room temperature and humidity? Check
8 Is your staff properly trained and evaluated in aseptic manipulation skills, gowning technique and clean-room use? Check
9 Do you filter (0.2 micron) in a Class 100 (ISO 5) laminar airflow hood contained in a Class 1000 (ISO 6) clean-room, or autoclave where appropriate, to achieve sterility? Check
10 Do you perform sterility testing according to USP <71> — Sterility Tests and USP <85> — Bacterial Endotoxin (Pyrogen) Test? Check
11 Do you have systems in place for handling complaints and investigating sterility failures and adverse events? Check
12 In the event of a sterility failure, complaint or adverse event, do you have a procedure in place for determining and conducting a recall, if necessary? Check
13 Do you purchase pharmaceutical-grade chemicals (USP, NF equivalent) from FDA-registered suppliers? Check
14 Do you obtain Certificate of Analyses for all formula ingredients? Check
15 Do you maintain both master formulas and lot-specific worksheets for all compounds? Check
16 Can you immediately trace a prescription back to the original formula log sheet and the source of ingredients? Check
17 Is every step of the compounding process from prescribing to compounding and labeling through dispensing reviewed and verified by a licensed pharmacist? Check
18 Are your pharmacists, technical and customer-service staff dedicated exclusively to compounding? Check
19 Does the pharmacy have adequate liability insurance? Check
20 Are you active members of the International Academy of Compounding Pharmacists? Do you belong to any other professional organizations? Check

Compounding Defined

The preparation, mixing, assembling, packaging, or labeling of a drug or device as the result of a practitioner—patient–pharmacist relationship in the course of professional practice. A customized medication prepared by a pharmacist according to a doctor’s specifications to meet an individual patient need. Pharmacists make medications from scratch using raw chemicals, powders and devices.

Compounding: The Need
The basis of the profession of pharmacy has always been the “Triad”, the patient-physician-pharmacist relationship. Through this relationship, patient needs are determined and decisions are made about treatment regimens that may include a compounded medication, including but not limited to:

  • Medications that are not commercially available
    Compounding allows the physician to prescribe a custom-tailored medication that is not available commercially.
  • Medications that are not stable
    Pharmacists prepare small quantities of a prescription more frequently to ensure stability of the product for its intended use.
  • Altered commercially available medications
    A patient may be allergic to a preservative or dye in a manufactured product that compounding pharmacists can prepare a dye-free or preservative-free dosage form. Some patients have difficulty swallowing a capsule and require a troche or lozenge.

Max Drugs Pharmacy specializes in compounding specialty prescriptions from U.S. licensed physicians. Max Drugs Pharmacy will dispense compounded medications only after receiving a valid prescription in accordance with U.S. federal law.