National Academies Press: OpenBook

Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use (2020)

Chapter: Appendix E: 503A and 503B Distribution Supplement

« Previous: Appendix D: Glossary
Suggested Citation:"Appendix E: 503A and 503B Distribution Supplement." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

Appendix E

503A and 503B Distribution Supplement

503A

Total estimates of 503A compounding pharmacies vary based largely on how a compounding pharmacy is defined. In a 2016 report, The Pew Charitable Trusts reported a total of more than 32,000 pharmacies in the United States that compound. This value was derived from the listing of pharmacies that report compounding functions in the National Council for Prescription Drug Programs Provider Database as of 2015. Submission of this information to the database was optional, and may not represent the true (and current) number of pharmacies that compound (The Pew Charitable Trusts, 2016). However, this estimate does not provide clarity on the extent of compounding services offered. The American Pharmacists Association estimates that there are approximately 7,500 pharmacies in the United States that specialize in compounding (American Pharmacists Association, 2020), a substantially lower estimate than the total 503A compounding pharmacies that perform any compounding.

503B

The value of 503B outsourcing facilities are reflective of those registered with the U.S. Food and Drug Administration as of February 2020. See Table E-1.

Suggested Citation:"Appendix E: 503A and 503B Distribution Supplement." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

TABLE E-1
Distribution of 503B Outsourcing Facilities by State

State Registered 503B Outsourcing Facilities
AL 2
AK 0
AR 4
AZ 4
CA 6
CO 4
CT 2
DC 0
DE 0
FL 9
GA 0
HI 0
IA 0
ID 1
IL 0
IN 0
KS 2
KY 0
LA 0
MA 2
MD 0
ME 0
MI 0
MN 1
MO 2
MS 0
MT 0
NC 1
ND 0
NE 0
NH 0
NJ 4
NM 0
NV 1
NY 6
OH 2
OK 1
OR 0
PA 2
RI 0
SC 4
SD 0
TN 3
TX 9
UT 0
VA 0
VT 1
WA 0
WI 0
WV 0
WY 0

SOURCE: FDA, 2020.

REFERENCES

American Pharmacists Association. 2020. Frequently asked questions about pharmaceutical compounding. https://www.pharmacist.com/frequently-asked-questions-about-pharmaceutical-compounding (accessed March 31, 2020).

FDA (U.S. Food and Drug Administration). 2020. Registered outsourcing facilities. https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities (accessed March 31, 2020).

The Pew Charitable Trusts. 2016. National assessment of state oversight of sterile drug compounding. Philadelphia, PA: The Pew Charitable Trusts.

Suggested Citation:"Appendix E: 503A and 503B Distribution Supplement." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
Page 285
Suggested Citation:"Appendix E: 503A and 503B Distribution Supplement." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
Page 286
Next: Appendix F: Adverse Events Table »
Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use Get This Book
×
Buy Paperback | $85.00 Buy Ebook | $69.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

Pain is both a symptom and a disease. It manifests in multiple forms and its treatment is complex. Physical, social, economic, and emotional consequences of pain can impair an individual’s overall health, well-being, productivity, and relationships in myriad ways. The impact of pain at a population level is vast and, while estimates differ, the Centers for Disease Control and Prevention reported that 50 million U.S. adults are living in pain. In terms of pain’s global impact, estimates suggest the problem affects approximately 1 in 5 adults across the world, with nearly 1 in 10 adults newly diagnosed with chronic pain each year.

In recent years, the issues surrounding the complexity of pain management have contributed to increased demand for alternative strategies for treating pain. One such strategy is to expand use of topical pain medications—medications applied to intact skin. This nonoral route of administration for pain medication has the potential benefit, in theory, of local activity and fewer systemic side effects. Compounding is an age-old pharmaceutical practice of combining, mixing, or adjusting ingredients to create a tailored medication to meet the needs of a patient. The aim of compounding, historically, has been to provide patients with access to therapeutic alternatives that are safe and effective, especially for people with clinical needs that cannot otherwise be met by commercially available FDA-approved drugs.

Compounded Topical Pain Creams explores issues regarding the safety and effectiveness of the ingredients in these pain creams. This report analyzes the available scientific data relating to the ingredients used in compounded topical pain creams and offers recommendations regarding the treatment of patients.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!