Revised 503B Guidance for Outsourcing Compounders

Mortar pharmacy

According to the Federal Register Notice that announced the guidance revision (here), the FDA notes that “This revised draft guidance reflects the FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to the nature of the specific compounding operations conducted by outsourcing facilities while maintaining the minimum standards necessary to protect patients from the risks of contaminated or otherwise substandard drug products.” The FR Notice also provides additional background on its thinking in making the revisions to the draft guidance.

Workplace Hazards that USP <800> could Prevent

The degree of danger that pharmacy workers are subject to depends on the kind of pharmacy they work in and its location. Pharmacists can be employed in community-, retail-, and hospital-based pharmacies, among others. Each of these workplace settings bring different hazards that need to be addressed to prevent harm.

1. Biological Hazards
Contact with patients and the public exposes pharmacy staff to biological hazards, as will contaminants found in food, water, and the ventilation system. The immunization of workers provides a first line of defense when interacting with patients.

Other measures should also be put into place, including the restriction of access to authorized personnel only, implementation of safe work procedures, and use of personal protective equipment, such as eye protection, gloves, and respiratory protection.

Care should not only be exercised on the medication contained within a pharmacy; the building itself should also be given attention, particularly the ventilation system. Regular maintenance reduces the risk of contamination.








Cleaning Program under the Revised Propositions

The proposed revisions to USP <795>, USP <797>, as well as proposed USP <800>, all include sections devoted to cleaning and surface sampling.

Proposed/Revised USP <795> defines cleaning as: The process of removing soil (eg, organic and inorganic material) from objects and surfaces, normally accomplished by manually or mechanically using water with detergents or enzymatic products

SOPs for USP <800> Pharmacy

Achieving and maintaining compliance with USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings is a continuous effort that requires unremitting attention and maintenance, including staff training, performance review, documentation, and quality improvement efforts. Developing comprehensive policies and procedures (P&Ps) and standard operating procedures (SOPs) is critical to ensuring compliance with the chapter (see TABLE: Recommended SOPs for USP <800> Compliance).

Trends in USP <800> Compliance

With less than a year to go until USP <800> becomes enforceable, a significant effort is required for many facilities to achieve compliance with this chapter. For many attaining full compliance will require an investment in facility upgrades, purchases of new PECs, and a renewed focus on staff training. Certainly progress has been made in adopting some 800-compliant practices; for example, most facilities already segregate their HD inventory from non-HDs in storage. However, other recommended practices are far from widespread; for example, few hospital pharmacies conduct HD spill simulations and wipe analyses on a regular basis. As such, many facilities do not have a firm understanding of the impact of HD contamination in their facility, nor can they be assured that their staff will respond properly when an HD spill inevitably occurs.

Nursing Perspective to USP <800>

Developing standard operating procedures (SOPs) and ensuring ongoing adherence is integral to a successful hazardous drug (HD) safety program. Furthermore, it is required by USP <800>, as Section 8 states that organizations must develop SOPs to cover all aspects of HD handling.

Preventing Contamination In Compounding Facilities

Compounding pharmacies come in many different shapes and sizes. They can consist of a pharmacist creating a drug under a doctor’s prescription or they can be pharmacy-type facilities that compound drugs and sell them like a manufacturer. Sporadic and serious infection outbreaks have been linked to compounding pharmacies outside of the hospital setting.1 These problems date back to as early as 1976.2 Despite attempts by the United States Pharmacopeia (USP) to make compounding safer, problems still occur.

Personnel Aseptic Practices Training

Personnel Aseptic Practices Training

The primary purpose of cleanroom gowning is to protect the products and the processing environment from human contamination.Cleanroom gowning greatly reduces the microorganisms released by personnel.All personnel should be properly gowning qualified before entering the cleanroom, and the qualification should be performed by a trained analyst. The degree of gowning should get more complex as the cleanroom grades increase.

Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan Tablets

Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) in the Products

Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets to the consumer level due to the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.

How should we Keep Cleanrooms Clean

Controlling microbial ingress into the cleanroom is a critical concern for the entire cleaning and disinfection process. Components, personnel, carts, tanks, tools, cleaning supplies, and instruments that are transferred into the clean area should be clean and free of contamination. Gross contamination is easier to prevent than to correct.

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