Compounding Pharmacy Regulation - Essay Example

Compounding Pharmacy Regulation Compounding Pharmacy Regulation A compounding pharmacy can be illustrated as a unique pharmacy that focuses and specializes in medication preparation through mixing of different ingredients to fulfill the requirements of certain patients. Compounding involve but not restricted to creation of modified drugs, developing of liquid versions of other solid medications to make them easer to swallow, adding flavors to medications especially for children and creating cream medication versions for application.

Compounding is usually undertaken as a result of contamination or adulteration of the original drug (FTM Resource guide, n.d).Compounding of pharmaceutical drugs requires unique training and careful handling in preparation. Some pharmaceuticals even require wearing of protective gadgets like gloves during preparation along with administration. During preparation, strict precautions are applied because some can even bring burns when handled inappropriately. Moreover, if an accident occurs during the process, different first aid techniques are applied to neutralize them.

Food and drug administration in many countries allow the compounded drugs on a directive that it should be prescribed and licensed by appropriate pharmacists. In addition, the substances used in compounding must qualify federal drugs act to be considered fit for consumption. It is essential to note that the quality of manufacturers is better than compounding pharmacies (U.S. Food and Drug Administration, 2007).The regulations to compounding of drugs are enforced by the Federal Food and Drug Administration (FDA).

These regulations are contained in the Code of Federal Regulations act. The CFR exempts pharmacies among the new drug requirement but does not excuse those pharmacies acting like manufacturers. The FDA exposes the compounded drugs to the same rules as other drugs and imposes fines and imprisonments to pharmacists who mix adulterated compounded drugs (Riley, 2004).The FDA also regulates misbranding of drugs that emerge as a result of compounding. This involves the inclusion of instructions and side effects of the drug on the prescription.

The key reason behind compounding is to provide a drug for unusual medication requirements. Other bodies involved in accrediting compounding include the Drug Enforcement Agencies and the Federal Trade Commission who directs record keeping, proper labeling and proper procedures. These same institutions are involved in licensing the compounding pharmacies.ReferencesFTM Resource guide (n.d). Compounding Pharmacies Retrieved from http://www.ftmguide.org/compounding.htmlRiley, R. J. (2004). The Regulation of Pharmaceutical Compounding and the Determination of Need:Balancing Access and Autonomy with Patient Safety Retrieved from http://www.leda.law.harvard.edu/leda/data/646/Riley.htmlU.S.

Food and Drug Administration (2007). Application of Federal Law to Practice of Pharmacy Compounding Retrieved from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm155666.htm