Compounding pharmacists responsibility

A number of criteria are used to select flavors during formulation. Different flavor concentrations produce highly subjective sensations. Specific requirements for balance and fullness are dependent, in part, on the drug substance and the physical form of the product. For this reason, when selecting a flavor system, the compounding pharmacist must take into account several variables upon which a desired response would depend. Some of these are product texture (e.g., viscosity of formulation, solid or liquid), water content, base vehicle or substrate, and taste of the subject drug. Notable specific examples to consider are ... 

Pharmacists are also responsible for compounding special ear preparations for pets that are not commercially available. Sometimes the availability and cost of certain medications are prohibitive for a veterinarian s private pharmacy. 

There is much legal responsibility involving veterinary compounding. It is strongly recommended that a pharmacist interested in veterinary compounding heed FDA rules and regulations. 

The 1997 Food and Drug Administration Modernization Act (FDAMA) specifically recognizes the right of a licensed pharmacist to compound pharmaceutical products in response to, or in anticipation of an appropriate prescription. The Act also authorized the establishment of an FDA Expert Advisory Committee... 

Organization and personnel describe that in the dispensing of all prescriptions, the pharmacist has the responsibility and authority to inspect and approve or reject all components, drug product containers, closures, in-process materials, and labeling. It also has the authority to prepare and review all compounding records to assure that no errors have occurred in the compounding process. The pharmacist is also responsible for fhe proper maintenance, cleanliness, and use of all equipmenf used in prescription compmmding practice. 

In summary, it is the responsibility of the pharmacist to select the most appropriate quality of chemical for compounding, beginning with the USP/NF as the first choice and, if this is not available, descending the list of purity grades using professional judgment and discretion. A certificate of analysis for the chemicals should be obtained and kept on file in the pharmacy for these selected chemicals [17,18]. 

The birth of drug discovery is closely connected to the study of plant natural products and was shaped by two seminal events, the isolation of morphine 1 from opium by the pharmacist Serturner in 18171 and the introduction in the clinics of Antipyrin 6 (phenazone) 70 years later, in 1887.2 The obtaining of a pure compound responsible for the medicinal properties of a crude drug marked the beginning of medicinal chemistry, triggering the transition from botanical extracts to pure molecules and eventually leading to the isolation of the active principle of most heroic drugs. 

In some European countries, the distribution of radioactive compounds to the users was considered the responsibility of the pharmacist. The first centralized isotope pharmacy was installed in Denmark, taking responsibility for the quality aud distribution of radioactive drugs since 1976. Different combinations of primary legislation for non-radioactive drugs (i.e., the Medicines Act) and national administrative arrangements provided legislation for consumer protection regulating the importation, manufacture, and sale or supply of radioactive medicinal products (Appendix A.2). 

Preparation and dispensing of radiopharmaceuticals is limited to dedicated radiopharmacies. Radiopharmaceuticals for patient use are usually prepared, controlled and dispensed in a hospital radiopharmacy department, but can also be dispensed on a named patient base by a centralised radiopharmacy ( compounding centre ) that operates on a commercial basis or by a centralised hospital pharmacy. The hospital (radio)pharmacist has the final responsibility for the quality of radiopharmaceuticals, also when purchased from an external (commercial) site. The responsible hospital pharmacist has to audit the external site and obtain a quality agreement, clarifying the mutual responsibilities. 

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