Pharmaceutical Technology BioPharm - May 2025

Pharmaceutical Technology BioPharm - May 2025

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26 Pharmaceutical Technology ® | BioPharm International ® Trends in Manufacturing May 2025 PharmTech.com COMPOUNDING v i e w/ c o m p o u n d i n g - o v e r v i e w - p r i m a r y - c o n s i d e r - at ions-in-t he-workplace, 12-18-23 (accessed Nov.1, 2024). 8. Pluta, P.L.; Mancini, A.M.; Thakar, N.B.; and Chaiyaperm, V. Pharmaceutica l Compounding Ca lculations in the Work- place Env i ron ment. Phar maceutical Technology, Trends in M anufact ur ing e B ook . M ay 202 4 . p2 7-3 4 . ht t ps:// w w w. pharmtech.com/view/pharmaceutical-compounding-calcu- lations-in-a-workplace-environment (accessed Nov.1, 2024). 9. FDA. Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (ICH, August 2007). https://www. fda.gov/regulatory-information/search-fda-guidance-doc- uments/q7a-good-ma nufac t ur i ng-prac t ice-g uida nce-ac- tive-pharmaceutical-ingredients (accessed Nov.1, 2024). 10. FDA. Bulk Drugs Used in Compounding Under Section 503A of the FD&C Act. FDA.gov. Sept. 26, 2024. https://www.fda. gov/drugs/human-drug-compounding/bulk-drug-substanc- es-used-compounding-under-section-503a-fdc-act (accessed Nov.1, 2024). 11. FDA. Bulk Drugs Used in Compounding Under Section 503B of the FD&C Act. FDA .gov. May 16, 2024. https://w w w.fda. gov/drugs/human-drug-compounding/bulk-drug-substanc- es-used-compounding-under-section-503b-fdc-act (accessed Nov.1, 2024). 12. Alliance for Pharmacy Compounding. Understanding Law and Reg ulation Govern ing t he Compounding of Peptide Products, March 1, 2024. https://join.a4pc.org/hubfs/PDFs/ APC-Peptides-Statement-March-1-2024.pdf ?hsLang=en (ac- cessed Apr. 15, 2025) 13. F DA. Bu l k Dr ug Subst a nces Nom i nated for Use i n Com- pounding under Section 503A of the Federal Food, Drug, & Cosmetic Acid, 9-20-23. 503A Categories Update for Septem- ber 2023 (accessed Nov. 1, 2024). 14. Pravastatin Pharmaceutical Compositions Having Good Sta- bility. US patent 5180589A, 1991. https://patents.google.com/ patent/US5180589A/en (accessed Nov. 1, 2024) 15. K hok ha r, W. A Dein, S.L. Quresh i, M.S., Ha meed, I., A li, M.M., Abba s t , Y.; a nd Sood , R . W hen Ta k i ng Med ic i ne May Be a Si n; Diet a r y Requ i rement s a nd Food L aws i n Ps ychot ropic Prescr ibi ng. BJ Psych Advances, Ca mbr idge Un iver sit y P ress, V21, #6, 2 Ja nu a r y 2018. ht t ps://w w w. c a m b r i d g e.or g /c or e/ j o u r n a l s/ b j p s y c h-a d v a n c e s/a r t i- c le/ whe n-t a k i n g-me d ic a t ion-m ay-b e -a-s i n- d ie t a r y-r e - q u i r e m e n t s -a n d-f o o d-l a w s -i n-p s y c h o t r o p i c -p r e s c r i b - ing/5E1A5178CD8AEF2915B852316CFEE305 (accessed Nov.1, 2024). 16. WHO. The Use of Stems in the Selection of International Non-Pro- pr ietar y Names (I N N ) for Phar maceut ical Substances 2018 (Stem Book 2018) a nd Addendum 2023. ht t ps://cd n.who. int/media/docs/default-source/internationa l-nonpropri- e t a r y-n a me s-(i n n)/s t e m b o ok-201 8.p d f ?s f v r s n=3 2 a5 1 b - 3c_6&download=true (accessed Nov.1, 2024). 17. Gupta, D.; Bhatia, D.; Dave, V.; Sulanya, V.; and Gupta, S.V. Salts of Therapeutic Agents. Molecules, July 14, 2018. https:// www.mdpi.com/1420-3049/23/7/1719 (accessed Nov.1, 2024). 18. ASHP. Guidelines on the Pharmacy and Therapeutics Com- m it tee a nd t he For mu la r y System. A mer ica n Societ y of Health System Pharmacists. 2021. https://www.ashp.org/-/ media/assets/policy-guidelines/docs/guidelines/gdl-phar- macy-therapeutics-committee-formulary-system.ashx (ac- cessed Nov.1, 2024). 19. FDA. FDA's Label i ng Resources for Huma n Prescr ipt ion Drugs for Industry. FDA.gov. Feb. 21, 2024. https://www.fda. gov/drugs/laws-acts-and-rules/fdas-labeling-resources-hu- man-prescription-drugs (accessed Nov. 1, 2024). 20. USP. USP L abel i ng. ht t ps:// w w w.u s p.org/ hea lt h-qu a l i- ty-safety/labeling (accessed Nov. 1, 2024). 21. FDA. Compounding Laws and Policies. FDA .gov. Sept. 10, 2020. (accessed Nov. 1, 2024). 22. FDA. FD&C Act Provisions that Apply to Human Drug Com- pounding. FDA.gov. Aug. 13, 2021. (accessed Nov. 1, 2024). 23. Abdus-Samad, Jibril. FDA Drug Product Nomenclature. FDA. gov. Dec. 4, 2019. https://www.fda.gov/media/134015/down- load (accessed Nov. 1, 2024). 24. USP Nomenclat ure Guidelines. USP.org. Ma rch 20, 2020. ht t ps://w w w.usp.org/sites/default/f i les/usp/document/ usp-nomenclature-guidelines.pdf (accessed Nov. 1, 2024). 25. USP <1121> Nomenclature. USP-NF. https://www.uspnf.com/ sites/default/files/usp _ pdf/EN/USPNF/1121Nomenclature. pdf (accessed Nov. 1, 2024). 26. USP. Guida nce for Implementat ion a nd Except ions: T he Monog raph Na m i ng Pol ic y for Sa lt D r ug s I D r ug P rod- uc t s a nd Compou nded P repa rat ion s I G enera l C h apter <1121> Nomenclature. USP.org. Sept. 5, 2019. https://w w w. u s p.or g /s i t e s/d e f a u l t/f i le s/ u s p/d o c u m e n t/o u r-w or k/ healthcare-qualit y-safet y/usp-guidance-for-implementa- tion-of-salt-naming-policy.pdf (accessed Nov. 1, 2024). 27. F DA. Na m i ng of Dr ug P roduc t s Cont a i n i ng Sa lt Dr ugs. F DA .gov. ht t ps://w w w.fda.gov/reg u lator y-i n for mat ion/ search-fda-guidance-documents/naming-dr ug-products- containing-salt-drug-substances (accessed Nov. 1, 2024). 28. FDA. Monograph Naming Policy for Salt Drug Substances in Dr ug Products and Compounded Preparations. Decem- ber 2014. https://www.youtube.com/watch?v=DadC-tXartU (accessed Nov. 1, 2024). 29. FDA. FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. FDA.gov. (accessed Nov. 1, 2024). 30. Collins, S. Semaglutide Shortage Gives Rise to Unauthorized Products. Pharmacy Today, August 2023. www.pharmacyto- day.org. (accessed Nov. 1, 2024). 31. FDA. FDA Reminds Compounders to Use Ingredients Suit- able for Sterile Compounding. FDA .gov. Oct. 30, 2024. (ac- cessed Nov. 1, 2024). 32. Phenytoin Dosage. Drugs.com. March 21, 2024. https://www. drugs.com/dosage/phenytoin.html (accessed Nov. 1, 2024). 33. Tylenol with Codeine Prescribing Information. Drugs.com. Dec. 12, 2023. https://www.drugs.com/pro/tylenol-with-co- deine.html (accessed Nov. 1, 2024). 34. FDA. Codeine Sulfate Prescribing Information. Reference ID 3306510. FDA .gov. May 2013. ht t ps://w w w.accessdata. fda.gov/dr ugsatfda _docs/ label/2013/022402s006lbl.pdf (accessed Nov.1, 2024). 35. ISMP. FDA Guidance Needed to Assure Safe Labeling Prac- tices by 503A and 503B Compounders. ISMP.org. March 22, 2018. ht t ps:// w w w.i smp.org/sites/def au lt/f i les/at t ac h- ments/2018-03/20180322_0.pdf (accessed Nov. 1, 2024). 36. ISMP. Heparin Errors Continue Despite Prior, High-Profile, Fatal Events. ISMP.org. June 17, 2008. https://www.ismp.org/ resources/heparin-errors-continue-despite-prior-high-pro- file-fatal-events (accessed Nov. 1, 2024). 37. Metoprolol succinate USP product label. Dr. Reddy's Labo- ratories, India. 38. Metoprolol succinate USP product label. Mylan Pharmaceu- ticals, Morgantown WV, USA. 39. Metoprolol succinate USP product label. Ohm Laboratories, New Brunswick, NJ, USA. 40. FDA. Potassium phosphates USP product label. Highlights of Prescribing Information, Potassium Phosphates Injection. FDA.gov. https://www.accessdata.fda.gov/drugsatfda_docs/ label/2019/212121s000lbl.pdf (accessed Nov. 1, 2024). 41. Pot a ssiu m phos ph ates USP produc t label, Hos pi ra , I nc. https:// labeling.pf izer.com/ShowLabeling.aspx?id=4586 (accessed Nov. 1, 2024). 42. Anectine succinylcholine chloride injection, USP. Sandoz, Inc. Princeton, NJ. FDA .gov. https://w w w.accessdata.fda. gov/d r ugsat fda _docs/ label/2010/008453s027lbl.pd f (ac- cessed Nov. 1, 2024). 43. Succinylcholine chloride injection, USP, product label. Hos- pira, Inc., Lake Forest, IL 60045. 44. Succinylcholine chloride injection, USP, product label. Am- ring Pharmaceuticals Inc., Berwyn, PA 19312. ■

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