If you are interested in pharmacy compounding as a physician or patient it is important to pick the right pharmacy that has the sterile equipment and properly trained pharmacists to safely produce the medications that you need. Compounded medications are perfectly safe to use when they are produced at the appropriate facility, and modern sterile compound pharmacies have the same equipment that commercial drug companies use to produce their medications. Modern pharmacies look a lot like laboratories and are equipped with top of the line air purification systems, sterile cleanrooms, precise electronic balances, and other equipment to ensure that any medications produced in the facility are accurately dosed and pure. Absolute Pharmacy is equipped with the proper top of the line equipment to produce high quality and pure compounded medications, and we have licensed pharmacists on staff who are in charge of producing all of our compounds. Absolute Pharmacy is a great choice for any type of medication compounding you may need for veterinary, hospice, sports medicine, pediatric, anti-aging, dental, men’s and women’s health, dermatology, hormone, or any other compounding purpose. Our compounded medications are guaranteed to be pure, and we are an excellent choice for physicians and patients in the state of Florida and elsewhere. We can also safely ship most of our compounded medications, and we are regulated by the Florida State Board of Pharmacy.
Check that the compounding pharmacy is regulated
One important thing to check is whether or not the pharmacy in question is regulated by the state Board of Pharmacy where it is located. The FDA does not regulate compounding pharmacies; instead it leaves it up to each state’s board of pharmacy to regulate their own local pharmacies. Each state has its own requirements for compounding pharmacy production practices, record keeping, labeling, ingredient sourcing and other requirements. The pharmacy that you are interested in using as a physician or patient should be registered and overseen by the state Board of Pharmacy. You can check this by contacting your state Board of Pharmacy and asking if the pharmacy in question is licensed. Although compounding pharmacies are regulated by each state, they must use FDA approved ingredients, and the FDA may also inspect pharmacies based on their own discretion. Compounding pharmacies must purchase their ingredients from FDA approved repackagers. There are also standards set by the US Pharmacopeial Convention (USP) which has set the standards for purity, strength, ingredients, and other requirements for compounded medications. These Standards of Care can be enforced by the FDA or state boards of pharmacy and they have been in effect since 1820. Absolute Pharmacy follows USP reference standards for all of our compounded medications. The USP’s standards are updated on a regular basis and are updated by over 900 volunteer experts, and any compounding pharmacy that produces safe and reliable medications should abide by USP standards. Also, the formulas used by a compounding pharmacy should be previously tested and guaranteed to be safe, and the formula should be approved by a licensed and trained pharmacist.
Make sure the pharmacy purchases ingredients from FDA approved distributors
Any right compounding pharmacy should source their ingredients only from FDA approved distributors. There are compounding pharmacies that do not obtain their ingredients from FDA approved sources, and as a result the quality, purity and safety of their compounds may be questionable. In most cases those pharmacies are also not regulated by their state board of pharmacy, and are not safe to purchase compounded medications from. Licensed compounding pharmacies will always purchase their ingredients from FDA approved sources. FDA approved distributors must also have their ingredient batches tested at an independent laboratory and receive a certificate of analysis (COA). The COA is a guarantee of the purity of the ingredient batch. The pharmacies that produce compounds from the batch should also receive a copy of the COA, and physicians can request a copy of the COA to confirm ingredient purity, or the pharmacy can direct the physician to their supplier who can provide more information on ingredient purity.
USP standards for sterile compounding
The USP also sets standards for sterile compounding that the best compounding pharmacies must follow. USP <797> is the document that outlines the standards for sterile compounded medication production, and the standards are enforceable by the FDA. The documents has the critical requirements for producing compounded medications that are safe for consumption by the public, and sterile compounding pharmacies must follow these guidelines and also have the proper equipment to follow the guidelines. Absolute Pharmacy abides by all of the guidelines of USP <797> to ensure proper sterile compound preparation and guarantee the strength, quality, and purity of our compounded medications.
Sterile cleanroom and proper facilities
Compounding pharmacies should have the proper equipment to produce sterile compounded medications, as there is a small risk of airborne contamination when compounded medications are produced or other sterile products. The International Organization for Standardization has reference standards for airborne particulates and has developed their ISO classification to describe the number of particles that are 0.5 µm or greater in diameter per cubic meter of air. For reference, an urban environment has over 35,000,000 particles per cubic meter of air, which corresponds to an ISO Class 9 cleanroom, and this level of contamination would never be allowed for sterile drug production. An ISO Class 5 environment must be used to produce compounded medications based on USP <797>, and it must be located within an ISO Class 7 cleanroom. An ISO Class 5 cleanroom has no more than 3,250 particles 0.5 µm or greater per cubic meter. Absolute Pharmacy is equipped with an ISO Class 5 cleanroom which is up to USP <797> standards and capable of producing any compounded medication safely. Our state of the art pharmacy has the latest equipment to produce compounded medications that are safe and we adhere to the latest USP guidelines for medication production. If you are a physician or a patient looking for a safe, reliable and licensed compounding pharmacy that uses state of the art sterile equipment to produce its medications, contact Absolute Pharmacy today for more information.
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