Current trends in compounding of medicines and its legislative regulation in foreign countries

Keywords: compounding medicines, quality control, legislative regulation


Compounding medicines preparation is part of the proper pharmaceutical supply of the population. Unfortunately, its volumes in Ukraine have been declining recently, but the spread of medicines production in privately owned pharmacies indicates the prospects of this activity type.

The aim of the work was the analysis of the current state of medicines compounding and its legislative regulation in foreign countries, formulation of the main directions of the Ukrainian legislation reforming on this issue.

The materials of the research were scientific publications in peer-reviewed foreign journals with using bibliosemantic method, the method of generalization and systematic data analysis.

The analysis of publications concerning the practice of medicines preparation in foreign countries showed its volume increasing. In most countries, such activities are an integral part of pharmaceutical care and the provision of medicines to the population. Along with conventional pharmacies, the widespread medicines compounding in hospital pharmacies. The structure of drug production differs in each country. According to the Global Market Insights report for 2018, the main therapeutic areas in the structure of compounding medicines market were hormone replacement therapy, analgesia, dermatology, specialized drugs and parenteral nutrition. The regulatory framework governing the medicines compounding was reviewed in the last few years. The EU updated the PIC/S Guide and approved the second version of the EU Council Resolution on the medicines compounding. To control the spread of sterile medicines serial preparation in the United States since 2013 this activity is controlled by the FDA. Compliance with GMP requirements is a mandatory requirement for the serial preparation of sterile medicines abroad.

Thus, the development of medicines compounding is a promising area of pharmaceutical activity. Despite the reduction in the number of compounding pharmacies, Ukrainian pharmacies are also involved in the preparation of specific medicines. A number of regulatory documents, the requirements of which are similar to international ones, regulates the quality control of compounding medicines. However, to comply with modern world trends, it is necessary to review and update this legislation.


Chym zhyla u 2019 r. Derzhliksluzhba – vidbuvsya publichnyy zvit // Yezhenedelnik Apteka. – 2020. – № 7 (1228). – URL:

Vlasenko I. O., Korytnyuk R. S., Rudenko V. V. Problemni pytannya pry vyhotovlenni likarsʹkykh zasobiv v umovakh aptek z analizom nomenklatury ridkykh likarskykh form. Povidoml. IV // Farmats. zhurn. – 2007. – № 1. – S. 32–37.

Polovko N. P., Zuykina E. V. Stan ekstemporalnoyi retseptury Ukrayiny ta problemy sohodennya // Zb. nauk. prats spivrob. NMAPO im. P. L. Shupyka. – 2018. – Vyp. 32. – S. 294–307.

Samborskyi O. S., Ievtushenko О. М., Slobodyanyuk N. N. Orhanizatsiya farmatsevtychnoyi dopomohy v Ukrayini: realiyi aptechnoho vyhotovlennya likarskykh zasobiv // Farmatsevtychnyy chasopys. – 2017. – № 4. – S. 87–98.

Korytnyuk R. S., Davtyan L. L., Shmatenko V. V., Maletska Z. V. Vidrodzhennya praktyky vyhotovlennya likarskykh zasobiv v umovakh apteky // Zb. nauk. prats spivrob. NMAPO im. P. L. Shupyka. – 2015. – Vyp. 24, Kn. 5. – S. 322–327.

Sanchez-Regana M., Llambi-Mateos F., Salleras-Redonnet M. et al. Compounding as a current therapeutic option in dermatology // Actas Dermosifiliogr. – 2013. – V. 104, N 9. – P. 738–756.

Ugalmugle S., Swain R. Compounding pharmacies market share. Statistics report 2025. Report ID: GMI749, 2020. URL:

Volmer D., Vendla K., Vetka A. et al. Pharmaceutical care in community pharmacies: practice and research in Estonia // Ann. Pharmacother. – 2008. – V. 42. – P. 1104–1111.

Kiselova O., Maurin B., Šidlovska V., Zvejnieks J. The extent of extemporaneous preparation and regulatory framework of extemporaneous compounding in Latvia // Medicina. – 2019. – V. 55, Is. 9.

Weekes L., Ramzan I. Prescription of compounded ophthalmic medications: a pharmacy perspective // Clin. Exp. Optom. – 2020.

Falconer J. R., Steadman K. J. Extemporaneously compounded medicines // Austr. Prescr. – 2017. – V. 40, N 1. – P. 5–8.

Dooms M., Carvalho M. Compounded medication for patients with rare diseases // Orphanet J. Rare Dis. – 2018. – V. 13.

AlKhatib H. S., Jalouqa S., Maraqa N. et al. Prevalence, determinants, and characteristics of extemporaneous compounding in Jordanian pharmacies // BMC Health Serv. Res. – 2019. – V. 19.

Frontini R., Miharija-Gala T., Sykora J. EAHP Survey 2010 on hospital pharmacy in Europe: Part 3. Production and quality assurance // Eur. J. Hosp. Pharm. – 2012. – V. 19. – P. 510–513.

Pawłowska I., Pawłowski L., Kocic I., Krzyzaniak N. Clinical and conventional pharmacy services in Polish hospitals: a national survey // Int. J. Clin. Pharm. – 2016. – V. 38. – P. 271–279.

Religioni U., Swieczkowski D., Gawrońska A., et al. Hospital audit as a useful tool in the process of introducing falsified medicines directive (FMD) into hospital pharmacy settings-a pilot study // Pharmacy (Basel). – 2017. – V. 5, Is. 4.

FDA’s human drug compounding progress report. Three years after enactment of the Drug Quality and Security Act / US Food and Drug administration. – January, 2017. URL:

Euphenia M., Fatima S., Thirumala G. Investigating extemporaneous compounding practices in the Polokwane tertiary hospital pharmacies in South Africa – a pilot study // Afr. J. Pharm. Pharmacol. – 2015. – V. 9 (48). – P. 1099–1105.

Kristina S. A., Wiedyaningsih C., Widyakusuma Nur N., Aditama H. Profile and determinants of compounding services among pharmacists in Indonesia // Asian J. Pharmac. – 2018. – V. 12 (3) (Suppl). – P. S966 –S970.

Nawab A., Farooq N., Rahat J. Compounding and dispensing practices in Karachi’s hospital pharmacy // J. Pharm. Pharm. Sci. – 2014. – V. 2 (1). – P. 18–22.

Aquilina A. The extemporaneous compounding of pediatric medicines at Mater Dei Hospital // J. Malta College of Pharmacy Practice. – 2013. – Is. 19. – P. 28–30.

Yusuff K. B. Extent of extemporaneous compounding and pattern of prescribing and use of extemporaneous medicines in a developing setting // J. Pharmac. Health Services Res. – 2019. – V. 10, N 2. – P. 255–260.

Musko M., Sznitowska M. Stability of extemporaneous pediatric oral liquids compounded from tablets and drug substance: case of propranolol and theophylline // Acta Pol. Pharm. – 2013. – V. 70, N 1. – P. 137–145.

Palmeira-de-Oliveira R., Macedo M., Machado R. M. et al. Pharmaceutical compounding in Portuguese community pharmacies: characterization and future perspectives // Int. J. Pharm. Compd. – 2016. – V. 20, N 2. – P. 114–122.

Valiev А. H., Zdoryk A. А. Analiz i puti rasshireniya assortimenta ekstemporalnykh lekarstvennykh sredstv v Respublike Tadzhikistan // Sci. J. «ScienceRise». – 2015. – № 11 (4). – S. 55–59.

Dimitrov M., Petkova V., Husain Sh. et al. Extemporaneous dispensing – comparative analysis between Greece and Bulgaria // World J. Pharm. Pharmac. Sci. – 2015. – V. 4, Is. 03. – P. 01–09.

Mohiuddin A. K. Extemporaneous compounding: selective pharmacists with separate skill // Inter. J. Pharmac. Chemistry and Analysis. – 2018. – V. 5, N 4. – P. 165–178.

USP Compounding Compendium / The United States Pharmacopeial Convention. – Rockwille. – 2018. – 693 p.

Lindon J. L. Who regulates compounding pharmacies? // Medscape. – 2012. URL:

Timko R. J. Applying quality by design concepts to pharmacy compounding // Int. J. Pharm. Compd. – 2015. – V. 19, N 6. – P. 453–463.

Sutton S. GMP and compounding pharmacies // Amer. Pharmac. Rev. – 2013. – V. 16, N 3. – P. 48–59.

Minghetti P., Pantano D., Gennari C. G. M., Casiraghi A. Regulatory framework of pharmaceutical compounding and actual developments of legislation in Europe // Health policy. – 2014. – V. 117. – P. 328–333.

Adoption of Model Standards for Compounding. URL:

Pharmaceutical preparations. In: European Pharmocopoeia, V. 1, 9th ed. – Strasbourg: European Directorate for the Quality of Medicines & HealthCare of the Council of Europe, 2016. – P. 5569–5571.

PIC/S Guide to good practices for the preparation of medicinal products in healthcare establishments. PE 010-4. 2014. URL:file:///D:/%D0%94%D0%BE%D0%BA%D1%83%D0%BC%D0%B5%D0%BD% D1%82%D1%8B/Downloads/pe_010_4_guide_to_good_practices_for_the_ preparation_of_medicinal_products_in_healthcare_establishments_copy1.pdf

Compounded medicines and good manufacturing practice (GMP). Guide to the interpretation of the PIC/S Guide to GMP for compounded medicinal products Version 2.0. – Australia, 2017. URL:

Good compounding practice, 1 st ed. – Malaysia: Centre for Compliance and Licensing National Pharmaceutical Regulatory Agency, 2018.

Scheepers H. P. A., Langedijk J., Neerup Handlos V. et al. Legislation on the preparation of medicinal products in European pharmacies and the Council of Europe Resolution // Eur J Hosp Pharm. – 2016. – Vol. 24. – P. 224–229.

Resolution CM/Res (2016)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients (Adopted by the Committee of Ministers on 1 June 2016 at the 1258th meeting of the Ministers’ Deputies). URL: safety_assurance_requirements_for_medicinal_products_prepared_in_pharmacies.pdf

Khemoteka. Tsentr personalizovanoyi farmatsiyi. URL:

Derzhavna farmakopeia Ukrainy: v 3 t. / DP «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv». – 2-e vyd. – Kharkiv: DР «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv», 2014. – T. 3. – 732 s.

Pro zatverdzhennia Pravyl vyrobnytstva (vyhotovlennia) ta kontroliu yakosti likarskykh zasobiv v aptekakh: nakaz MOZ Ukrainy № 812 vid 17. 10. 2012 r. – K., 2012. – 28 s. URL:

Vymohy do vyhotovlennia nesterylnykh likarskykh zasobiv v umovakh aptek: Nastanova ST-N MOZU 42-4.5:2015, zatverdzheni Nakazom MOZ Ukrainy № 398 vid 01.07.15. – K., 2015. – 109 s. URL:

Vymohy do vyhotovlennia sterylnykh ta aseptychnykh likarskykh zasobiv v umovakh aptek: nastanova ST-N MOZU 42-4.5:2015, zatverdzheni Nakazom MOZ Ukrainy № 398 vid 01. 07. 15. – K., 2015. – 76 s. URL:

Vlasenko I. O., Korytnyuk R. S., Rudenko V. V. Metodychni pidkhody do rozrobky tekhnolohichnykh instruktsiy vyhotovlennya likarskykh zasobiv v umovakh aptek // Farmats. zhurn. – 2006. – № 3. – S. 43–47.

How to Cite
Savchenko, L. P., & Georgiyants, V. A. (2020). Current trends in compounding of medicines and its legislative regulation in foreign countries. Farmatsevtychnyi Zhurnal, (4), 6-17.
Management of pharmacy