Pharmaceutical compounding refers to the science by which personalized medications are prepared. The process is done by a licensed pharmacist, and it involves combining, mixing, or altering ingredients in a drug so that the created medication is tailored to meet the particular needs of a person. Prescription for compounded medication must be made by a licensed physician. Any Ocala compounding pharmacy is licensed and certified by the state and federal authorities to engage in the business of preparing medicines.
For a process to be referred to as compounding, two or several drugs must be combined together. There are several reasons why it may be necessary to compound medication for a patient. First, medication may need to be compounded because the specific medical needs of a patient cannot be met by conventional medicine on the market. Such a situation may arise where a patient is allergic to certain elements included in conventional 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.
Some years back, compounding was the mode of producing all kinds of prescribed medications. However, with the emergence of mass production in the 50s and 60s, this changed. Mass production changed the roles played by pharmacists of preparing medications to dispensing manufactured drugs. The training of pharmacists in drug preparation was limited almost to a point of extinction.
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.
For a process to be referred to as compounding, two or several drugs must be combined together. There are several reasons why it may be necessary to compound medication for a patient. First, medication may need to be compounded because the specific medical needs of a patient cannot be met by conventional medicine on the market. Such a situation may arise where a patient is allergic to certain elements included in conventional 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.
Some years back, compounding was the mode of producing all kinds of prescribed medications. However, with the emergence of mass production in the 50s and 60s, this changed. Mass production changed the roles played by pharmacists of preparing medications to dispensing manufactured drugs. The training of pharmacists in drug preparation was limited almost to a point of extinction.
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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