Pharmacy compounding is the science of preparing personalized medications for patients. In this process, a licensed physician or a licensed pharmacist mixes, combines, or alters the ingredients of a drug in order to create a medication that is tailored to the specific needs of an individual patient. Usually, the medication is prescribed by a medical practitioner to the meet the specific needs of a patient. Any Ocala compounding pharmacy is certified and licensed to operate in the area.
The term compounding is only used on processes that involve mixing or combining several drugs to produce a single medication. Different reasons make it necessary for a patient to require compounded medication. For starters, one may need such medication if they do not get affected in the required manner by conventional medication. An instance like that is where one exhibits allergic reaction to certain components making up a given medication.
The purpose of compounded drugs is to meet the needs that are specific to the patient in question. That means that they are in most cases not FDA approved. As such, they are not verified by the FDA for safety and effectiveness. Effectiveness and safety are matters ensured by drug approval processes, which ensure compliance with federal regulations in matters related to manufacturing.
Usually, the responsibility of ensuring that state-licensed compounding pharmacies stick to the set standards in their operations rests with state boards of pharmacies. However, the FDA also has some authority over these facilities too. Additionally, the FDA imposes stricter regulation over outsourcing facilities. The FDA also conducts inspections based on a risk-based schedule.
The services, operations, and products in these pharmacies are associated with certain risks and health concerns. Often these concerns and risks are due to lack of compliance with FDA standards. There are reports that drugs are compounded without following quality practices. The effect is that there is increased risk of contamination, super-potency, sub-potency, and adulteration of drugs. The likelihood of people using compounded drugs over those that are approved by the FDA contributes to the risks.
Advancements in technology are enabling pharmacists to compound medications that are safer and more effective at a high degree of precision. The technological developments in this field have resulted in the revolution and standardization of various processes that pharmacists use to make drugs. Today, it is possible to compound drugs that are very specific in their ingredient, dosage, strength, and flavor requirements.
At some point in the past, almost all prescriptions from medical practitioners were compounded. However, in the 1950s and 1960s, there was a change in the scales of drug production, leading to mass production of medications. Pharmacists initially acted as preparers of medication, but the advent of mass production reduced their roles to dispensers of manufactured medications. With that, pharmacists were not trained in the art and science of preparing medications anymore.
However, mass production did not satisfy the needs of everybody. Some people had their needs not met because they need custom tailored medications. That returned compounding pharmacies into business. Today, federal regulations state that these facilities must at any given time have a licensed pharmacist onsite.
The term compounding is only used on processes that involve mixing or combining several drugs to produce a single medication. Different reasons make it necessary for a patient to require compounded medication. For starters, one may need such medication if they do not get affected in the required manner by conventional medication. An instance like that is where one exhibits allergic reaction to certain components making up a given medication.
The purpose of compounded drugs is to meet the needs that are specific to the patient in question. That means that they are in most cases not FDA approved. As such, they are not verified by the FDA for safety and effectiveness. Effectiveness and safety are matters ensured by drug approval processes, which ensure compliance with federal regulations in matters related to manufacturing.
Usually, the responsibility of ensuring that state-licensed compounding pharmacies stick to the set standards in their operations rests with state boards of pharmacies. However, the FDA also has some authority over these facilities too. Additionally, the FDA imposes stricter regulation over outsourcing facilities. The FDA also conducts inspections based on a risk-based schedule.
The services, operations, and products in these pharmacies are associated with certain risks and health concerns. Often these concerns and risks are due to lack of compliance with FDA standards. There are reports that drugs are compounded without following quality practices. The effect is that there is increased risk of contamination, super-potency, sub-potency, and adulteration of drugs. The likelihood of people using compounded drugs over those that are approved by the FDA contributes to the risks.
Advancements in technology are enabling pharmacists to compound medications that are safer and more effective at a high degree of precision. The technological developments in this field have resulted in the revolution and standardization of various processes that pharmacists use to make drugs. Today, it is possible to compound drugs that are very specific in their ingredient, dosage, strength, and flavor requirements.
At some point in the past, almost all prescriptions from medical practitioners were compounded. However, in the 1950s and 1960s, there was a change in the scales of drug production, leading to mass production of medications. Pharmacists initially acted as preparers of medication, but the advent of mass production reduced their roles to dispensers of manufactured medications. With that, pharmacists were not trained in the art and science of preparing medications anymore.
However, mass production did not satisfy the needs of everybody. Some people had their needs not met because they need custom tailored medications. That returned compounding pharmacies into business. Today, federal regulations state that these facilities must at any given time have a licensed pharmacist onsite.
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