We often discuss USP <797> but it is vitally important to understand just what the regulation entails…

Drug adherence is a crucial component of the modern-day healthcare system. It is a very important factor in today’s economy, making up a sizable chunk of the country’s total GDP.

The compounded pharmaceutical industry contributes to the betterment of public health. Not only do they produce drugs that can save lives, but they take part in different research to manufacture new chemical compounds that could possibly revolutionize healthcare.

The Need for Regulations

As with other industries, regulations are put in place to ensure quality standards. While this is important regarding goods and services being made available to the general public, a greater level of consequence lies in the pharmaceutical industry due to the direct effect they have on public health.

Different countries have regulatory systems in place for maintaining quality assurance in the pharmaceutical industry. In the United States, this job has been delegated to the Food & Drug Administration and various State Boards of Pharmacy. Both agencies perform various roles in ensuring that consumers and healthcare professionals are able to have access to drugs that are safe, effective, and pass quality standards at all times.

An Introduction to USP <<797>>

When the USP Chapter <797> guidelines were published in 2008 by the United States Pharmacopeia, the government had minimum surveillance over sterile compounding procedures other than a bit of paperwork and general precautionary measures. That changed after high-profile tragedies[i] occurred as a result of contaminated medications.

The USP <797> regulations happen to be one of the most comprehensive summaries of requirements that compounding facilities must follow. These guidelines were created with three objectives:

  1. For quality control in terms of cleanliness, hygiene, sanitation, and sterility. Preparations made by these facilities are to be deemed safe for use by the public.
  2. To ensure that drug manufacturers are given a safe environment to work in without the risk of being exposed to chemicals in drugs that are used in their development.
  3. To maintain quality throughout the chemical’s life cycle. Be it in preparation, storage, or dispersal.

Compounding Pharmacies & Their Relationship to USP <797>

The FDA has divided compounding pharmacies into two sectors: 503A and 503B pharmacies.

Both sectors deal with the manufacture of compounding or customizing medications, albeit with different restrictions. For more detail, on the differences between 503A and 503B compounding companies, please review our previous blog post.

While 503A pharmacies compound in smaller quantities, 503B pharmacies manufacture in much larger quantities. The USP <797> guidelines are to be followed, even if the two happen to play different roles in the medical sector.

503B pharmacies are held to a higher standard than a typical pharmacy. Some of the key principles and rules that 503B pharmacies are required to adhere to are given below:

  • WORKFLOW – The workflow process is not specified and is left to other agencies or the pharmacy.
  • PRODUCTION – The production is allowed for multiple products simultaneously in the designated cleanroom.
  • POST-DATED MEDICATION TESTING REQUIREMENTS – There is a certain degree of leniency involving compounded sterile preparations (from the time of initial preparation up to the time of administration). The ‘Beyond-Use-Date’ system applies to high-risk drugs.
  • FINAL CONTAINER TESTING – There is no testing mechanism to check the sterility of the final container that is used for storing the drugs.
  • MATERIAL TESTING – The materials used in the production process are not required to be tested.
  • TEMPERATURE LEVEL MONITORING – There are strict guidelines required for maintaining a stable temperature; with daily evaluations and monitoring being mandatory.
  • ENVIRONMENTAL MONITORING – Environmental monitoring is also mandatory under the regulation, with air quality being inspected every 6 months, surface areas on a periodic basis (>6 months) and personnel about 1-2 times a year.
  • STERILE GARBING – There are regulations regarding the handling of drugs; with all those who come in direct contact with the drugs being required to use sterile gloves at all times.
  • PRESCRIBED DISINFECTANTS – The prescribed disinfectant is isopropyl alcohol.
  • PRODUCTION MONITORING – There are no regulations regarding the use of equipment, process, IT systems, and cleaning validation.
  • DOCUMENTATION – The primary authority for setting the standards would be in accordance with both the FDA as well as the state boards.
  • CHANGE CONTROL – There are no regulations regarding changing the manufacturing process of the drugs.
  • ADVERSE DRUG EVENTS – There are no regulations regarding Adverse Drug Events or ADE, which consider causative factors.

The Need for Regulatory Standardization

This gives a clear understanding of how 503B pharmacies are regulated as well as the general expectation of their work environment. The USP <797> regulations are just one component of a larger system.

503B pharmacies must also comply with cGMP (Current Good Manufacturing Practice) requirements. These were put in place to ensure pharmaceutical quality by employing up-to-date testing methods akin to any commodities manufacturing plant.

Ever since the US FDA implemented cGMP, the department has started to guide companies toward this more rigorous standard.[ii] While both regulations are required, the USP <797> regulations are becoming antiquated and is very likely to be phased out very soon for the stricter regulations. The US FDA has started to accelerate the process with the intention to have it in force in the very near future.

Not only will it benefit the FDA and local pharmacy boards in terms of providing a regulatory framework; it will also help pharmaceutical facilities by providing a better business environment to operate in. Most importantly, it will benefit patients who will receive drugs that have undergone more scrutiny in the manufacturing process and therefore, have more data to attest to their safety, and validity.

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[i] Myers, Charles. (2013). Sterile Compounding: History of Sterile Compounding in U.S. Hospitals: Learning from the tragic lessons from the past. American Society of Health-System Pharmacists. Vol. 70. (PDF file). Bethesda, MD. Retrieved from

[ii] Food and Drug Administration. (2003, February 27). Pharmaceutical Current Good Manufacturing Practices for the 21st Century: A Risk-Based Approach; Establishment of a Public Docket. Federal Register. The Daily Journal Of The United States Government. Retrieved from