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.
It was the primary role of pharmacists to produce compounded drugs before the 1950s and 1960s. They accepted prescriptions from other medical professionals to compound drugs that suited particular needs of patients. This practice later changed in the 50s and 60s when drugs started to be mass-produced. The duties of pharmacists had to change when mass production of drug started.
Thus, the role of pharmacists moved from compounding drugs to solely dispensing them. Pharmacists were no longer trained in the art of creating compounded drugs during training in medicine school. However, before too long, it became apparent that there were gaps in the market that mass production of drugs could not cover. Some patients had personalized problems that mass producers could not address because the problems were not prevalent.
There is a variety of reasons why compounded drugs may be more suitable for certain patients. The first reason is when one has an individualized problem that cannot be addressed by a drug that is available on the market commercially. For instance, one may need a commercial drug, but because of an allergy to some of the components of the drug, they cannot use it. Thus, excluding the cause of allergy in the compounded drug solves the problem.
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.
Compounded drugs do not have FDA approval in the US. The approval is denied because it is hard for FDA to verify the safety and effectiveness of such drugs. Despite this, there are standards governing the manufacturing process of compounded drugs to ensure quality and safety. Before being marketed to the public all compounded drugs must fulfill these standards.
Oversight and direct supervision of compounding pharmacies is a responsibility assumed by state boards of pharmacy. Even with state boards taking jurisdiction over these facilities, the FDA also has some say in what they do in some cases. For instance, all outsourcing facilities remain under the oversight and regulation of the FDA. They have to comply with regular inspections as well as set standards.
There is a possibility that compounded drugs can pose certain health risks. It is for this reason that FDA does not approve of their use. In some cases, the production line is of poor quality due to malpractices. Also, the ingredients utilized could be contaminated. Besides, these are likely to be ineffective. This implies that patients are using drugs which have not been approved on the basis of their efficiency and safety.
It was the primary role of pharmacists to produce compounded drugs before the 1950s and 1960s. They accepted prescriptions from other medical professionals to compound drugs that suited particular needs of patients. This practice later changed in the 50s and 60s when drugs started to be mass-produced. The duties of pharmacists had to change when mass production of drug started.
Thus, the role of pharmacists moved from compounding drugs to solely dispensing them. Pharmacists were no longer trained in the art of creating compounded drugs during training in medicine school. However, before too long, it became apparent that there were gaps in the market that mass production of drugs could not cover. Some patients had personalized problems that mass producers could not address because the problems were not prevalent.
There is a variety of reasons why compounded drugs may be more suitable for certain patients. The first reason is when one has an individualized problem that cannot be addressed by a drug that is available on the market commercially. For instance, one may need a commercial drug, but because of an allergy to some of the components of the drug, they cannot use it. Thus, excluding the cause of allergy in the compounded drug solves the problem.
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.
Compounded drugs do not have FDA approval in the US. The approval is denied because it is hard for FDA to verify the safety and effectiveness of such drugs. Despite this, there are standards governing the manufacturing process of compounded drugs to ensure quality and safety. Before being marketed to the public all compounded drugs must fulfill these standards.
Oversight and direct supervision of compounding pharmacies is a responsibility assumed by state boards of pharmacy. Even with state boards taking jurisdiction over these facilities, the FDA also has some say in what they do in some cases. For instance, all outsourcing facilities remain under the oversight and regulation of the FDA. They have to comply with regular inspections as well as set standards.
There is a possibility that compounded drugs can pose certain health risks. It is for this reason that FDA does not approve of their use. In some cases, the production line is of poor quality due to malpractices. Also, the ingredients utilized could be contaminated. Besides, these are likely to be ineffective. This implies that patients are using drugs which have not been approved on the basis of their efficiency and safety.
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