Manufacturing Guidelines Play Vital Role in Safety of Compounded Drugs

Compliance by outsourcing facilities decreases patient risks

Manufacturing Guidelines Play Vital Role in Safety of Compounded Drugs
Medical vials


Compounded drugs can serve an important role for patients whose clinical needs cannot be met by medications approved by the U.S. Food and Drug Administration (FDA). While these drugs are generally prepared for individuals based on a patient-specific prescription, medical providers may also seek non-patient-specific supplies of compounded drugs—known as office stock—to administer in an outpatient or hospital setting. For example, many hospitals maintain stocks of compounded injections to relieve pain that can be administered to patients with an immediate need. Under federal law, only certain compounders known as outsourcing facilities can compound and distribute non-patient-specific drug products for use as office stock.

Office stock products present risks. They are often stored before use, which increases the opportunity for contaminants such as bacteria and fungus to grow to dangerous levels, or for ingredients to deteriorate, which can cause drugs to become less potent or degrade in ways that pose safety concerns. Also, because such drugs are sometimes produced at significant scale, more patients are potentially exposed if products are contaminated or otherwise substandard.

To reduce these risks, outsourcing facilities must comply with Current Good Manufacturing Practice (CGMP) requirements, issued by FDA, that also apply to conventional pharmaceutical companies. The table below highlights key CGMP topics from draft guidance FDA issued in December 2018, and provides examples of how these guidelines decrease risks to patient safety.


  1. FDA’s regulations regarding Current Good Manufacturing Practice (CGMP) requirements for finished pharmaceuticals in Chapter 21 of the Code of Federal Regulations (21 CFR), Parts 210 and 211, provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities to assure the identity, strength, quality, and purity of drug products.
  2. On Dec. 10, 2018, FDA issued draft guidance that described its specific expectations for outsourcing facilities regarding compliance with CGMP. U.S. Food and Drug Administration, “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug and Cosmetic Act” (2018), Although it is a draft version, it is applicable until FDA issues final regulations (or an updated draft).
  3. U.S. Food and Drug Administration, “Federal Judge Enters Order of Permanent Injunction Against Paul W. Franck,” news release, April 29, 2016,
  4. U.S. Department of Veterans Affairs, Office of Inspector General, “Healthcare Inspection: Oversight Review of Ophthalmology Adverse Drug Events, VA Greater Los Angeles Healthcare System, Los Angeles, California,” Report No. 12-01515-151 (2012),
  5. Eric S. Kastango and Katherine H. Douglass, “Quality Standards for Large Scale Sterile Compounding Facilities” (2014), Clinical IQ LLC.
  6. Kathleen Ross et al., “Outbreak of Septic Arthritis Associated With Intra-Articular Injections at an Outpatient Practice — New Jersey, 2017,” Morbidity and Mortality Weekly Report 66, no. 29 (2017): 777-779,
  7. U.S. Food and Drug Administration, “FDA notifies health care professionals that Becton-Dickinson replaced problematic rubber stoppers in its syringes,” accessed Jan. 2, 2019,
  8. U.S. Food and Drug Administration, “FDA Alerts Drug Makers of a Recall of Porcine Thyroid API from Sichuan Friendly Pharmaceutical Co., Limited, China,” accessed Oct. 22, 2018,
  9. Centers for Disease Control and Prevention, “Deaths From Intravenous Colchicine Resulting From a Compounding Pharmacy Error—Oregon and Washington, 2007,” Morbidity and Mortality WeeklyReport 56, no. 40 (2007): 1050–52,
  10. American Society of Health-System Pharmacists, “Compounding Suppliers Issue Recalls of Products Tested by Front Range Laboratories,” news release, Aug. 28, 2013,
  11. U.S. Food and Drug Administration, “Pharmakon Pharmaceuticals 5/21/15,” accessed Nov. 15, 2018,
  12. U.S. Food and Drug Administration, “FDA Announces Pharmakon Pharmaceuticals’ Nationwide Voluntary Recall of Purportedly Sterile Drug Products,” accessed Oct. 23, 2018,