Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use (2020)
Chapter: Appendix E: 503A and 503B Distribution Supplement
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.
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.
