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Drug compounding refers to the process of mixing, altering, or combining ingredients composed in a drug for the purpose of creating medication that would address specific needs of an individual patient. Only licensed pharmacists of physicians are allowed to undertake this process. If the production is happening in an outsourcing facility, supervision must be provided by a licensed pharmacist. When in need of Compounding Pharmacies Ocala FL should be visited.
Before the 195o and 1960s, pharmacists had the primary role of producing compounded drugs. They received prescriptions from a medical practitioner and compounded drugs to suit the specific needs of their patients. However, this changed when drugs began to be produced in masses in the 50s and 60s. With mass production of drugs, the role of pharmacists changed.
They changed to dispensing drugs to patients according to their perceptions as they no longer compounded drugs. Training schools also stopped training them in compounding drugs and shifted focus to other areas. Unfortunately, it was realized that mass production of drugs failed to address all needs of patients. This meant that pharmacists had to go back to the practice of compounding drugs.
Patients require compounded drugs for many reasons. The first reason is that, a patient may have unique medical needs which cannot be met by commercially produced drugs on the market. For example, a patient may be allergic to commercially produced drugs available on the market. They allergy could be as a result of certain compounds included in the drug. As such, eliminating the undesired ingredient might solve the issue.
Secondly, small children or elderly citizens may find it hard to swallow large tablets of drugs. The same case often applies to pets, which cannot swallow drugs. This can be solved by providing a compounded alternative, which may be in the form of a liquid. The patient or pet can then drink the liquid with more ease. Besides liquids, compounded drugs may also be made in the form of creams or lotions.
In the US, compounded drugs do not have the approval of the FDA. This is because the safety and effectiveness of the preparations cannot be ascertained by the FDA. However, to ensure quality and safety, all manufacturing processes are governed by strict regulations and standards. Before the preparations are marketed, they must meet certain standards in their process of production as well the product themselves.
Oversight and supervision of compounding pharmacies rests with the state boards of pharmacy in every jurisdiction. FDA retains certain authority over operations despite state boards having full responsibility over these establishments within their jurisdictions. FDA oversees and has direct regulation over every outsourcing facility. A part from regular inspection by FDA outsourcing facilities operates in compliance of various requirements.
There may be some health risks associated with compounded drugs since they do not have FDA approval. The use of poor quality practices is one of the causes of possible risks. Also, use of contaminated ingredients is a possibility. The efficiency of the preparation is often questionable, given that they are not researched and approved for efficiency and safety.
Before the 195o and 1960s, pharmacists had the primary role of producing compounded drugs. They received prescriptions from a medical practitioner and compounded drugs to suit the specific needs of their patients. However, this changed when drugs began to be produced in masses in the 50s and 60s. With mass production of drugs, the role of pharmacists changed.
They changed to dispensing drugs to patients according to their perceptions as they no longer compounded drugs. Training schools also stopped training them in compounding drugs and shifted focus to other areas. Unfortunately, it was realized that mass production of drugs failed to address all needs of patients. This meant that pharmacists had to go back to the practice of compounding drugs.
Patients require compounded drugs for many reasons. The first reason is that, a patient may have unique medical needs which cannot be met by commercially produced drugs on the market. For example, a patient may be allergic to commercially produced drugs available on the market. They allergy could be as a result of certain compounds included in the drug. As such, eliminating the undesired ingredient might solve the issue.
Secondly, small children or elderly citizens may find it hard to swallow large tablets of drugs. The same case often applies to pets, which cannot swallow drugs. This can be solved by providing a compounded alternative, which may be in the form of a liquid. The patient or pet can then drink the liquid with more ease. Besides liquids, compounded drugs may also be made in the form of creams or lotions.
In the US, compounded drugs do not have the approval of the FDA. This is because the safety and effectiveness of the preparations cannot be ascertained by the FDA. However, to ensure quality and safety, all manufacturing processes are governed by strict regulations and standards. Before the preparations are marketed, they must meet certain standards in their process of production as well the product themselves.
Oversight and supervision of compounding pharmacies rests with the state boards of pharmacy in every jurisdiction. FDA retains certain authority over operations despite state boards having full responsibility over these establishments within their jurisdictions. FDA oversees and has direct regulation over every outsourcing facility. A part from regular inspection by FDA outsourcing facilities operates in compliance of various requirements.
There may be some health risks associated with compounded drugs since they do not have FDA approval. The use of poor quality practices is one of the causes of possible risks. Also, use of contaminated ingredients is a possibility. The efficiency of the preparation is often questionable, given that they are not researched and approved for efficiency and safety.
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