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September 21, 2017

How Different Agencies Help to Set Temperature Monitoring Standards

Written by TempAlert

Pharmacy temperature compliance is inherently complex. That probably doesn’t come as a surprise. But, there’s a historical reason for this complexity. Currently, at least four different regulatory and non-regulatory bodies govern all of those rules and regulations: USP, CDC, FDA and State Boards of Pharmacy. Not only that, but the rules, regulations, and guidelines are constantly evolving. And any decision made by one body could have a ripple effect on the others.

To sort out these relationships, in this post we take a high-level look at each of these agencies to see how they operate together to set temperature monitoring guidelines for pharmacy safety.

U.S. PHARMACOPEIAL CONVENTION

First up is the U.S. Pharmacopeial Convention (USP). This not-for-profit organization sets standards for many different issues related to pharmacies. It’s important to remember that none of their recommendations are legally binding. Nevertheless, other agencies more often than not look to USP standards when determining and setting their own guidelines. In short, although USP does not have any direct law making, governing, or enforcing authority, other regulatory entities point to the USP as a reference, so it’s essential to keep an eye on them.

Currently, the USP defines the range of acceptable temperatures for medications and vaccines but does not specify how to ensure that they are stored within those proper ranges. While they have offered a bit more information for certain circumstances (e.g., sterile compounding, drug manufacturing), overall USP instructions are vague. That’s probably because USP experts assume the “how” is implied. For instance, it’s implied that each medication needs to stay within a certain temperature range 24/7—and by extension, therefore implies the requirement of continuous monitoring. But, the USP does not explicitly spell out this expectation.

STATE BOARDS OF PHARMACY

Next, each of the 50 states has its own State Board of Pharmacy.

This can make temperature regulation very confusing for large national chains. Why?  Because no federal entity governs all of the Boards—meaning standards can change significantly across state borders. Still, 17 states specifically refer to USP standards, and most have modeled their regulations on those standards.

If the USP makes a change—for example, adjusting a temperature range specification—many board of pharmacy regulations automatically follow suit. In effect, states have the authority to make USP guidelines the law, enforce them, perform inspections, request temperature logs, and dispense citations or fines for noncompliance. Unfortunately, the degree and frequency of enforcement varies from state to state.

THE CENTERS FOR DISEASE CONTROL AND PREVENTION

The Centers for Disease Control and Prevention (CDC) oversees programs at the national level that have a major impact on how states implement pharmacy temperature monitoring.

One particular CDC program is considered the “gold standard” for how medications and vaccines should be handled and stored: Vaccines for Children (VFC). VFC is federally funded and pushed out at the state level. The program employs coordinators from inside state health departments who have the authority to create and enforce their own rules (sometimes different from general CDC guidelines).

The Vaccines for Children program increasingly sets the tone for both the USP and state boards of pharmacy. We are seeing a move toward treating all vaccines and medications with the same level of care that is applied by VFC guidelines.

FOOD AND DRUG ADMINISTRATION

Finally, also at the national level, is the Food and Drug Administration (FDA).

The FDA works directly with vaccine and medication manufacturers to set guidelines for appropriate storage temperatures. When trials occur, FDA officials determine which conditions best guarantee the safety and efficacy of a specific pharmaceutical or biologic. So, when they hit the market, it is expected that they will continuously maintain proper temperatures concerning those conditions (e.g., humidity, light exposure, room temperature, cold temperatures).

What’s next?

Looking at the map below, it’s easy to see how different temperature monitoring rules and regulations vary from state to state. None of the laws or guidelines set by any one of these four agencies are set in stone. In fact, we expect major changes for the future. Expect to see the map get darker and darker!

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Topics: Pharmacy Safety