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.
Compounded medications are often tailored to accommodate the specific requirements of the patient. For that reason, they are not FDA-approved. That means that their safety and effectiveness is not verified by the FDA. The drug approval process is relied upon by patients and physicians to ensure the effectiveness and safety of products. Drug approval process exists to make sure that operations are standardized according to federal laws.
Normally, it is the responsibility of state boards of pharmacy to ensure that state-licensed compounding pharmacies observe set standards in all operations they undertake. However, the FDA continues to continues to exert a certain degree of influence on the establishments too. Outsourcing facilities are usually subjected to stricter regulation by the FDA. Outsourcing facilities need to be inspected by FDA inspectors 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.
Because of advancements in technology, pharmacists are now able to produce safer and more affective medications with a high level of precision. Many technological advancements have occurred in this field, which have led to standardization and revolution of several processes used in the making of drugs. Today, many pharmacies can compound drugs to meet specific strength, flavor, dosage, and ingredient 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, as always, did not meet the needs of all patients. There were some patients who still needed customized drugs, and so, compounding pharmacies continued to exist. Today, it is a requirement for a licensed pharmacist to be on-site at any pharmacy involved in the preparation and dispensation of medications.
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.
Compounded medications are often tailored to accommodate the specific requirements of the patient. For that reason, they are not FDA-approved. That means that their safety and effectiveness is not verified by the FDA. The drug approval process is relied upon by patients and physicians to ensure the effectiveness and safety of products. Drug approval process exists to make sure that operations are standardized according to federal laws.
Normally, it is the responsibility of state boards of pharmacy to ensure that state-licensed compounding pharmacies observe set standards in all operations they undertake. However, the FDA continues to continues to exert a certain degree of influence on the establishments too. Outsourcing facilities are usually subjected to stricter regulation by the FDA. Outsourcing facilities need to be inspected by FDA inspectors 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.
Because of advancements in technology, pharmacists are now able to produce safer and more affective medications with a high level of precision. Many technological advancements have occurred in this field, which have led to standardization and revolution of several processes used in the making of drugs. Today, many pharmacies can compound drugs to meet specific strength, flavor, dosage, and ingredient 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, as always, did not meet the needs of all patients. There were some patients who still needed customized drugs, and so, compounding pharmacies continued to exist. Today, it is a requirement for a licensed pharmacist to be on-site at any pharmacy involved in the preparation and dispensation of medications.
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