Understanding Compliance: Can Pharmacists Compound with Drugs on the FDA “Negative List”?

Understanding Compliance: Can Pharmacists Compound with Drugs on the FDA “Negative List”?

i-cadeceusAll compounding pharmacists should have heard of the Food and Drug Administration’s “Negative List,” also known as the “do not compound” list, where the agency lists all of the pharmaceutical compounds that may not be used in custom compounded medications. Compounding pharmacists may not compound with drugs listed on the FDA’s “Negative List.” Like anything that comes about through regulation and compromise, however, the story of the “do not compound” list is more nuanced than its purely negative moniker would suggest. 

Born in 1997 as part of the Food and Drug Administration Modernization Act (FDAMA), the current iteration of the negative list represents the foundation of efforts between the FDA and compound pharmacies to collaborate toward better patient safety. Compounding pharmacies often support some level of industry standardization and regulation, as long as it is aimed at cementing compounding pharmacology as a legitimate and valuable part of the pharmaceutical industry. Compounding pharmacies would also prefer to ensure that quality compounding pharmacies are not punished for the reprehensible actions of the industry’s outliers.1

The best way to ensure that you are acting in accordance with the law and your patients’ best interests as a compounding pharmacy operator or a compounding pharmacist is to make sure to stay educated about why compounds are on the list, how exactly they are listed, any exceptions to the rule, and the laws of your individual state compared with federal regulations.

How Do Compounds End Up on the Negative List?

The ultimate authority regarding what compounds are added to the negative list has always belonged to the FDA. In 2013, however, as part of the Drug Quality and Security Act, the FDA agreed to form and consult with a Pharmacy Compounding Advisory Committee (PCAC) before adding anything to the list. The PCAC includes 12 voting members and a chair, with “representation from the National Association of Boards of Pharmacy, the United States Pharmacopoeia, pharmacists with background and knowledge in compounding, and patient and public health advocacy organizations.”2

In their 2014 meeting following the 2013 passage of the Act, the PCAC voted to add 25 new compounds to the FDA negative list. Typically, compounds are on the do-not-compound list because they were removed from the market for safety reasons. Of course, no compounding pharmacist wants to compound with unsafe materials that might cause adverse effects, but things are rarely so straightforward in pharmacology. This is why it’s crucial for compounding pharmacists to fully understand all the compounds on the list and the ways they are listed. For instance, some compounds are listed by certain dosage forms and others refer to specific chemical salts. In those cases, safe iterations of that compound may, in fact, exist and not appear on the list.

Additionally, many medications in common use, especially in the world of compound pharmaceuticals, are not “finished” drug products that would be eligible to receive FDA approval. More than 200 commonly used drug products actually predate the 1938 enactment of the Food and Drug Cosmetic Act that granted the Food and Drug Administration its authority to control marketing and distribution of drugs. Drugs that fall into this gray area of “commonly compounded and clearly showing no adverse effects” but also “not FDA approved” include medications like codeine, morphine, hydrocodone, and many others.

It would hardly be unusual for a pharmacist to work with and dispense a form of medication that contained one of these compounds, though many states will require at the very least a United States Pharmacopeial Convention (USP) monograph for a substance that is not an FDA-approved medication.3

Are There Exceptions to the FDA Negative List?

One of the hardest aspects about staying compliant in the pharmaceutical world is the many layers of regulation that exist. There are regulations at the federal level, certainly, that pharmacists must track, but there are also numerous regulatory frameworks that are left entirely up to state legislatures or even simply state branches of national pharmacology associations to govern. The FDA negative list is a prime example of a federal regulation that is interpreted and enforced differently depending on a pharmacy’s state location.

A 2001 ruling called Thompson v. Western States Medical Center actually struck down entire provisions of the FDAMA, effectively negating the federal negative list for an entire region of the country. Pharmacies in Washington, Oregon, Idaho, Montana, Nevada, California, and Arizona are effectively freed from the federal requirement to refrain from compounding with items on the negative list, though this certainly does not remove any safety or moral requirement, or indeed any state-level regulations governing the use of these compounds. 4

Pharmacists have a very direct and specific responsibility to ensure patient safety when formulating medications. Compounding pharmacists have a unique ability to truly customize the drug and pharmacology experience for patients to maximize effectiveness and minimize adverse effects, so ensuring that you are not working with any compound known to have safety issues is a professional responsibility.

Relying on the combined knowledge of the PCAC and the FDA to create and maintain the negative list certainly helps everyone to avoid known problem compounds, but it’s also a pharmacist’s responsibility to be educated whenever an absolute like “never compound with these” is presented. It’s only by knowing all the facts that we’re able to make the best decisions for our customers and patients, after all.

Pharmaceutica North America is a leading provider of high-quality compounding kits and active pharmaceutical ingredients for compounding pharmacies and other health care organizations. Contact us to learn more about our products.

Show 4 footnotes

  1. “Basics of Compounding: The ‘Negative’ List,” July 2015, https://www.ijpc.com/Abstracts/Abstract.cfm?ABS=4009
  2. “Pharmacy Compounding Advisory Committee,” Nov. 17, 2014, http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/default.htm
  3. “Frequently Asked Member Questions, International Academy of Compounding Pharmacists,” January 2015, http://c.ymcdn.com/sites/www.iacprx.org/resource/resmgr/FAQs/August_2015_IACP_FAQ_Documen.pdf
  4. “Thompson, Secretary of Health and Human Services, et al. v. Western States Medical Center et al,” accessed Dec. 29, 2015, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/UCM155167.pdf
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