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503 Compliance for Healthcare

The world is getting smaller but also more complex due to technological advances and increased regulation.


Hospital and health system pharmacies which are critical to patient care and operating revenue.

Medical facilities often struggle to keep up with rapidly advancing therapeutics and heavy regulatory burdens. 

While 503A facilities are exempt from cGMP (current good manufacturing practices) they are still subject to FDA inspections and USP <797> standards. 

With limited resources and in-house expertise, hospitals and healthcare facilities need a partner they can trust to meet regulatory compliance challenges - as evident in the FDA’s common 503A pharmacy observations:

  • Deficiencies in Environmental Monitoring program (59.6% 170 occurrences)

  • Gowning of personnel engaged in compounding of sterile products inadequate (58.2% 166 occurrences)

  • Room and Equipment cleaning, sanitization + disinfection deficiencies that frustrate preservation of aseptic conditions (53.3% 152 occurrences)

  • No written stability program to assess the stability characteristics of drug products (41.1% 117 occurrences)

  • Procedures designed to prevent microbial contamination of drug products purporting to be sterile are not established written and followed (37.5% 107 occurrences)


​To protect patient access to life-saving medications and a valuable network revenue stream - HIPP helps hospitals and healthcare facilities cost-efficiently navigate the regulatory landscape. 

Because we understand that small-scale manufacturing must be flexible and efficient, making the most of limited resources we address the following key design requirements while seeking to minimize project capital and operational cost.  

  1. Separation of compounding and dispensing areas: The pharmacy must have a separate area for compounding medications and a separate area for dispensing them. This helps prevent contamination and ensures that medications are prepared in a sterile environment.

  2. Cleanroom: The compounding area must have a cleanroom that meets USP <797> standards for sterile compounding. This includes requirements for air quality, surface cleanliness, and personnel garbing.

  3. Equipment: The pharmacy must have equipment that is appropriate for the types of medications it compounds. This may include scales, mixers, ovens, and other specialized equipment.

  4. Storage: The pharmacy must have appropriate storage areas for raw materials, finished products, and other supplies. These storage areas must be secure, climate-controlled, and labeled appropriately.

  5. Standard Operating Procedures (SOPs): The pharmacy must have written SOPs for all compounding processes and must follow them consistently. These SOPs should include instructions for cleaning and sanitizing equipment, preparing and packaging medications, and handling hazardous materials.

  6. Quality control: The pharmacy must have a system in place to ensure the quality of the medications it prepares. This may include testing for potency, sterility, and endotoxin levels, as well as regular monitoring of equipment and personnel.

Contact us today to learn how our experts can help.

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503 Compliance
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