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Compounding pharmacy regulations: experience of the North American pharmaceutical market

https://doi.org/10.17749/2070-4909/farmakoekonomika.2022.155

Abstract

In order to improve regulation of socially significant type of activity in the field of compounding pharmacy production, the review summarizes the technological, organizational and regulatory requirements for ensuring quality and safety of compounding drugs, as well as historical and technical analysis of the compounding pharmacy regulation in North American pharmaceutical market. The main imperatives are identified and the best practices recommended for implementation into the current state of the pharmaceutical market in the Russian Federation. 

About the Authors

D. D. Mamedov
Saint Petersburg State Chemical Pharmaceutical University
Russian Federation

Devi D. Mamedov – Junior Researcher, Laboratory of Regulatory Relations and Good Practice

14 lit. A Professor Popov Str., Saint Petersburg 197022



D. S. Yurochkin
Saint Petersburg State Chemical Pharmaceutical University
Russian Federation

Dmitriy S. Yurochkin – Researcher, Laboratory of Regulatory Relations and Good Practices

14 lit. A Professor Popov Str., Saint Petersburg 197022



A. A. Leshkevich
Saint Petersburg State Chemical Pharmaceutical University
Russian Federation

Andrey А. Leshkevich – Junior Researcher, Laboratory of Regulatory Relations and Good Practices

14 lit. A Professor Popov Str., Saint Petersburg 197022



S. E. Erdni-Garyaev
Saint Petersburg State Chemical Pharmaceutical University
Russian Federation

Sergey E. Erdni-Garyaev – Senior Lecturer, Chair of Physical and Colloidal Chemistry

14 lit. A Professor Popov Str., Saint Petersburg 197022



Z. M. Golant
Saint Petersburg State Chemical Pharmaceutical University
Russian Federation

Zakhar M. Golant – PhD (Econ.), Head of Laboratory of Regulatory Relations and Good Practices

14 lit. A Professor Popov Str., Saint Petersburg 197022



I. A. Narkevich
Saint Petersburg State Chemical Pharmaceutical University
Russian Federation

Igor A. Narkevich – Dr. Pharm. Sc., Professor, Rector

WoS ResearcherID: C-1131-201

14 lit. A Professor Popov Str., Saint Petersburg 197022



References

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8. Nolan A. Federal authority to regulate the compounding of human drugs. CRS Report for Congress, 2013. Available at: https://sgp.fas.org/crs/misc/R43038.pdf (accessed 28.09.2022).

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10. Watson C.J., Whitledge J.D., Siani A.M., Burns M.M. Pharmaceutical compounding: a history, regulatory overview, and systematic review of compounding errors. J Med Toxicol. 2021; 17 (2): 197–217. https://doi.org/10.1007/s13181-020-00814-3.


Review

For citations:


Mamedov D.D., Yurochkin D.S., Leshkevich A.A., Erdni-Garyaev S.E., Golant Z.M., Narkevich I.A. Compounding pharmacy regulations: experience of the North American pharmaceutical market. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2023;16(1):80–86. (In Russ.) https://doi.org/10.17749/2070-4909/farmakoekonomika.2022.155

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ISSN 2070-4909 (Print)
ISSN 2070-4933 (Online)