Compounding

In the [[United States]], compounding pharmacies are licensed and regulated by states. National standards have been created by the Pharmacy Compounding Accreditation Board (PCAB),{{cite web |url=http://www.iacprx.org/site/PageServer?pagename=FAQs |archive-url=https://web.archive.org/web/20060819002609/http://www.iacprx.org/site/PageServer?pagename=FAQs |archive-date=2006-08-19 |title=International Academy of Compounding Pharmacists: Frequently Asked Questions |access-date=2010-07-18}} however, obtaining accreditation is not mandatory and inspections for compliance occur only every three years.Kotz, Deborah (2012-10-11) [https://www.boston.com/dailydose/2012/10/11/how-risky-are-compounding-pharmacies/5qEMXl6fMzSl4fTtolachJ/story.html How risky are compounding pharmacies?]. Boston.com. Retrieved on 2013-05-13. The [[Food and Drug Administration]] (FDA) has authority to regulate "manufacturing" of pharmaceutical products—which applies when drug products are not made or modified as to be ''tailored in some way to the individual patient''—regardless of whether this is done at a factory or at a pharmacy.

In the [[United States]], compounding pharmacies are licensed and regulated by states. National standards have been created by the Pharmacy Compounding Accreditation Board (PCAB),{{cite web |url=http://www.iacprx.org/site/PageServer?pagename=FAQs |archive-url=https://web.archive.org/web/20060819002609/http://www.iacprx.org/site/PageServer?pagename=FAQs |archive-date=2006-08-19 |title=International Academy of Compounding Pharmacists: Frequently Asked Questions |access-date=2010-07-18}} however, obtaining accreditation is not mandatory and inspections for compliance occur only every three years.Kotz, Deborah (2012-10-11) [https://www.boston.com/dailydose/2012/10/11/how-risky-are-compounding-pharmacies/5qEMXl6fMzSl4fTtolachJ/story.html How risky are compounding pharmacies?]. Boston.com. Retrieved on 2013-05-13. The [[Food and Drug Administration]] (FDA) has authority to regulate "manufacturing" of pharmaceutical products—which applies when drug products are not made or modified as to be ''tailored in some way to the individual patient''—regardless of whether this is done at a factory or at a pharmacy.

In the Drug Quality and Security Act (DQSA) of 2013 (H.R. 3204),{{cite web |url= https://www.govtrack.us/congress/bills/113/hr3204/text |title=Text of H.R. 3204: Drug Quality and Security Act (Enrolled Bill version) |publisher=GovTrack.us |date= November 21, 2013 |access-date= 2014-02-18}} Congress amended the Federal Food, Drug, and Cosmetic Act (FFDCA) to clarify limits of FDA jurisdiction over patient-specific compounding, and to provide an optional pathway for "non-traditional" or bulk compounders to operate. The law established that pharmacies compounding only "patient-specific" preparations made in response to a prescription (503A pharmacies) cannot be required to obtain FDA approval for such products, as they will remain exclusively under state-level pharmacy regulation. At the same time, section 503B of the law regulates "outsourcing facilities" which conduct bulk compounding or are used as outsourcing for compounding by other pharmacies. These outsourcing facilities can be explicitly authorized by the Food and Drug Administration under specified circumstances, while being exempted from certain requirements otherwise imposed on mass-producers. In any pharmacy, compounding is not permitted for a drug product that is "essentially a copy" of a mass-produced drug product; however, outsourcing pharmacies are subject to a broader definition of "essentially a copy". For traditional/patient-specific compounding, 503A's definition of "copy" retains its original focus on drug ''products'' or ultimate dosage forms rather than drug substances or active ingredients,{{cite web |url=https://www.nhia.org/resource/legislative/503AStatute.cfm |title=Compounding Legislation Action Center - Section 503A |publisher=National Home Infusion Association |year=2010 |access-date=2014-02-18 |archive-url=https://web.archive.org/web/20131203040019/https://www.nhia.org/resource/legislative/503AStatute.cfm |archive-date=2013-12-03 |url-status=dead }} and in any event it explicitly excludes from its definition any compounded drug product that a given patient's prescribing practitioner determines makes a "significant difference" for the patient.

In the Drug Quality and Security Act (DQSA) of 2013 (H.R. 3204),{{cite web |url= https://www.govtrack.us/congress/bills/113/hr3204/text |title=Text of H.R. 3204: Drug Quality and Security Act (Enrolled Bill version) |publisher=GovTrack.us |date= November 21, 2013 |access-date= 2014-02-18}} Congress amended the Federal Food, Drug, and Cosmetic Act (FFDCA) to clarify limits of FDA jurisdiction over patient-specific compounding, and to provide an optional pathway for "non-traditional" or bulk compounders to operate. The law established that pharmacies compounding only "patient-specific" preparations made in response to a prescription (503A pharmacies) cannot be required to obtain FDA approval for such products, as they will remain exclusively under state-level pharmacy regulation. At the same time, section 503B of the law regulates "outsourcing facilities" which conduct bulk compounding or are used as outsourcing for compounding by other pharmacies. These outsourcing facilities can be explicitly authorized by the Food and Drug Administration under specified circumstances, while being exempted from certain requirements otherwise imposed on mass-producers. In any pharmacy, compounding is not permitted for a drug product that is "essentially a copy" of a mass-produced drug product; however, outsourcing pharmacies are subject to a broader definition of "essentially a copy". For traditional/patient-specific compounding, 503A's definition of "copy" retains its original focus on drug ''products'' or ultimate dosage forms rather than drug substances or active ingredients,{{cite web |url=https://www.nhia.org/resource/legislative/503AStatute.cfm |title=Compounding Legislation Action Center - Section 503A |publisher=National Home Infusion Association |year=2010 |access-date=2014-02-18 |archive-url=https://web.archive.org/web/20131203040019/https://www.nhia.org/resource/legislative/503AStatute.cfm |archive-date=2013-12-03 |url-status=dead }} and in any event it explicitly excludes from its definition any compounded drug product that a given patient's prescribing practitioner determines makes a "significant difference" for the patient. {{Cite web |date=2026-04-16 |title=Pharmacy Oversight by State: Warnings, Recalls, 503B |url=https://formblends.com/pharmacy-oversight |access-date=2026-04-23 |website=FormBlends |language=en}}

The FDA weighs the following factors in deciding whether it has authority to "exercise its discretion" to require approval for a custom-compounded drug product:{{cite web|url=https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm134919.htm |archive-url=https://web.archive.org/web/20100309060156/https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm134919.htm |archive-date=2010-03-09 |title=Medical Center Pharmacy v. Mukasey |publisher=Food and Drug Administration|access-date=2012-02-05}}

The FDA weighs the following factors in deciding whether it has authority to "exercise its discretion" to require approval for a custom-compounded drug product:{{cite web|url=https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm134919.htm |archive-url=https://web.archive.org/web/20100309060156/https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm134919.htm |archive-date=2010-03-09 |title=Medical Center Pharmacy v. Mukasey |publisher=Food and Drug Administration|access-date=2012-02-05}}