Skip to main content
SpringerLink
Log in

Navigating Through a Complex and Inconsistent Regulatory Framework: Section 503B of the Federal Food Drug and Cosmetic Act Outsourcing Facilities Engaged in Clinical Investigation

  • Special Section on Pharmaceutical Compounding
  • Published:
Therapeutic Innovation & Regulatory Science Aims and scope Submit manuscript

Abstract

The integrity of unbiased clinical data is essential to the future of the health care system by facilitating the discovery of lifesaving medicines and ensuring investigational drugs are safe and effective. Since 2002, the US pharmaceutical industry has invested over $500 billion, which is the largest research and development investment of any sector of the US economy. As a consequence of this significant investment, pharmacy compounders and other stakeholders must be acutely aware of the consequences of noncompliance. Pharmacy compounders are required to navigate through a complex and ever-changing regulatory landscape governed by US federal and state authorities competing for oversight and enforcement authority. In particular, pharmacy compounders participating in clinical investigation are faced with inconsistent federal and state drug labeling regulations, which can lead to enforcement for violating acceptable standards for clinical investigation and informed consent. As FDA registrants, Outsourcing Facilities are able to produce large volumes of clinical supplies without the need for prescriptions for individually named patients. Some states, however, may have prescription drug labeling laws that could thwart the ability to provide these clinical supplies. Accordingly, researchers should be aware of the implications of federal and state laws, including any inconsistencies, prior to engaging in clinical investigation.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Pharmaceutical Research and Manufacturers of America (PhRMA). 2013 Biopharmaceutical research industry profile, pharmaceutical research and manufacturers of America: introduction. http://www.phrma.org/sites/default/files/pdf/PhRMA%20Profile%202013.pdf. Published July 2013. Accessed January 15, 2016.

  2. US Pharmacopeia. Chapter 795, Pharmaceutical Compounding—Nonsterile Preparations (2014).

  3. Allen LV Jr. The Art, Science and Technology of Pharmaceutical Compounding. 4th ed., American Pharmacists Association 2012

  4. Western States Med Ctr v Shalala, 238 F3d 1090 (9th Cir 2001).

  5. Kessler DA, MD, Commissioner of Food and Drugs, Department of Health and Human Services. Speech presented at: Subcommittee on Health and Environment, Committee on Commerce, House of Representatives; May 1, 1996.

  6. 21 USC § 353(a) (2016).

  7. Thompson v Western States Med Ctr, 535 US 357, 365 (2002).

  8. Outterson K. Regulating compounding pharmacies after NECC. N Engl J Med. 2012;10:1056.

    Google Scholar 

  9. Med Ctr Pharmacy v Mukasey, 536 F3d 383, 392 (5th Cir 2008).

  10. 21 USC § 353 (2014).

  11. US Food and Drug Administration. Guidance: pharmacy compounding of human drugs under Section 503A of the Federal Food, Drug, and Cosmetic Act. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469119.pdf. Published October 2015. Accessed January 15, 2016.

  12. US Food and Drug Administration. Guidance for industry: current good manufacturing practice—interim guidance for human drug compounding facilities under Section 503B of the FD&C Act. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm403496.pdf. Published July 2014. Accessed January 15, 2016.

  13. Draft guidance: pharmacy compounding of human drug products under Section 503A of the Federal Food, Drug, and Cosmetic Act; withdrawal of guidances. Fed Regist. 2013;78(233). http://www.gpo.gov/fdsys/granule/FR-2013-12-04/2013-28963

  14. US Food and Drug Administration. FDA implementation of the Compounding Quality Act. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm375804.htm. Published July 22,2015. Accessed January 15, 2016.

  15. US Food and Drug Administration website. FY 2014 inspectional observation summaries. http://www.fda.gov/ICECI/Inspections/ucm424098.htm. Published November 28, 2014. Accessed January 15, 2016.

  16. Erickson AK. Tomorrow’s drugs: improving lives through clinical trials. http://www.pharmacist.com/tomorrow%E2%80$99s-drugs-improving-lives-through-clinical-trials. Published April 1, 2013. Accessed January 15, 2016.

  17. Misra S. Randomized double blind placebo control studies, the “gold standard” in intervention based studies, Indian J Sex Transm Dis. 2012;33:131–134.

    Article  Google Scholar 

  18. 21 CFR § 201.57(c)(18) (2016).

  19. 21 CFR § 201.80(f)(2) (2016).

  20. National Institute of Allergy and Infectious Diseases. US Department of Health and Human Services, National Institutes of Health, Pharmacy Guidelines and Instructions for DMID Clinical Trials. http://www.niaid.nih.gov/labsandresources/resources/dmidclinrsrch/Pages/protdev.aspx. Accessed January 15, 2016.

  21. Karlberg J, Speers M, eds. Reviewing clinical trials: a guide for the ethics committee. https://www.pfizer.com/files/research/research_clinical_trials/ethics_committee_guide.pdf. Published March 2010. Accessed January 15, 2016.

  22. 21 CFR § 312.6 (2016).

  23. National Conference of State Legislatures. State regulation of compounding pharmacies. http://www.ncsl.org/research/health/regulating-compounding-pharmacies.aspx. Published October 1, 2014. Accessed November 13, 2015.

  24. Cal Bus & Prof Code, § 4000 et seq. (2016).

  25. Cal Code of Regs tit 16, § 1700 et seq. (2016).

  26. Cal Health & Safety Code, § 11000 et seq. (2016).

  27. Cal Bus & Prof Code, § 4076(a) (2016).

  28. Cal Bus & Prof Code, § 4078 (2016).

  29. 21 CFR § 312.2 (2016).

  30. NJ Stat Ann § 45:14-40 et seq. (2016).

  31. NJ Admin Code § 13:39-1.1 et seq. (2016).

  32. NJ Admin Code § 13:39-7.12 (2016).

  33. NJ Admin Code § 13:39-9.10(c) (2016).

  34. NJ Admin Code § 13:39-9.2 (2016).

  35. NJ Admin Code § 13:39-11.12 (2016).

  36. Colo Rev Stat § 12–42.5-128 (2016).

  37. Minn R 6800.3400 (2014); and N.Y. Educ. Law §§ 6816, 6817 (2016).

  38. NY Comp Codes R & Regs tit 63, § 63.12 (2016).

  39. Ariz Admin Code § R4-23-658 (2016).

  40. Del Code Ann tit 24, § 2500 et seq. (2016).

  41. 24 Del Code Regs § 2500 et seq. (2016).

  42. Fla Stat § 465 et seq. (2016).

  43. Haw Code R § 16-95-79 et seq. (2016).

  44. Ill Admin. Code tit. 68, § 1330.670 (2016).

  45. Neb Rev Stat §§ 71-2401-71-2405 (2016).

  46. Ohio Rev Code Ann § 3719 et seq. (2016).

  47. Tex Occ Code Ann § 563.052 (2016).

  48. Wash Rev Code §§ 18.64.246, 69.04.570, 69.04.630 (2016).

  49. American Pharmacists Association. Code of Ethics for Pharmacists, American Pharmacists Association. http://www.pharmacist.com/code-ethics. Published October 14, 1994. Accessed January 15, 2016.

  50. 45 CFR § 46 et seq. (2016).

  51. Gallin J, Ognibene F. Principles and Practice of Clinical Research. London: Academic Press; 2002.

    Google Scholar 

  52. 21 CFR Parts 50 and 56 (2016); 45 CFR Part 46 (2016).

  53. 21 CFR § 50.20 (2016).

  54. US Food and Drug Administration. Informed Consent Information Sheet. http://www.fda.gov/RegulatoryInformation/Guidances/ucm404975.htm. Published July 2014. Accessed January 15, 2016.

  55. Pub L No. 113-54, 102(a), 127 Stat. 587, 587–88 (2013).

  56. 21 USC § 356b(d)(4), FDCA 503B(d)(4) (2014).

  57. Cal Bus & Prof Code, § 4078(b) (2016).

  58. NJ Admin Code § 13:39-9.10(c) (2016).

  59. 21 USC §§ 352(f)(1), 355 (2016).

  60. US Food and Drug Administration. Guidance for industry, current good manufacturing practice—interim guidance for human drug compounding outsourcing facilities under Section 503B of the FD&C Act. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm403496.pdf. Published July 2014. Accessed January 15, 2016.

  61. 21 CFR Parts 210 and 211 (2016).

  62. 21 CFR § 312.42(b) and 21 CFR § 312.44(b) (2016).

  63. US Food and Drug Administration. Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding. http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM095852.txt.

  64. US Food and Drug Administration. Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-16011.pdf. Published July 2014. Accessed January 15, 2016.

  65. 79 FR 44805—outsourcing facility fee rates for fiscal year 2015. Fed Regist. 2014;79(148). 44805 (August 1, 2014). http://www.gpo.gov/fdsys/granule/FR-2014-08-01/2014-18111

  66. US Food and Drug Administration. Registered outsourcing facilities. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm Published January 8, 2016. Accessed January 15, 2016.

  67. US Food and Drug Administration. Guidance for industry: fees for human drug compounding outsourcing facilities under Sections 503B and 744 of the [FDCA], at § III. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM391102.pdf. Published November 2014. Accessed January 15, 2016.

Download references

Author information

Authors and Affiliations

  1. Center on Drugs & Public Policy, University of Maryland School of Pharmacy, 220 Arch Street 12th Floor, Baltimore, MD, 21201, USA

    Francis B. Palumbo PhD, JD

  2. Baker & Hostetler, Washington, DC, USA

    Lee H. Rosebush PharmD, JD, MS, MBA

  3. Hogan Lovells US LLP, Washington, DC, USA

    Lowell M. Zeta JD, LLM

Authors
  1. Francis B. Palumbo PhD, JD
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Lee H. Rosebush PharmD, JD, MS, MBA
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Lowell M. Zeta JD, LLM
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Francis B. Palumbo PhD, JD.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Palumbo, F.B., Rosebush, L.H. & Zeta, L.M. Navigating Through a Complex and Inconsistent Regulatory Framework: Section 503B of the Federal Food Drug and Cosmetic Act Outsourcing Facilities Engaged in Clinical Investigation. Ther Innov Regul Sci 50, 270–278 (2016). https://doi.org/10.1177/2168479015618695

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1177/2168479015618695

Keywords

Search

Navigation