case study

Remediation and Compliance within New FDA Regulatory Framework

A recently registered 503B Sterile Outsourcing Facility was facing serious enforcement action from the FDA. Under RCA’s guidance, the company became one of the first outsourcing facilities to remediate FDA’s sterility assurance concerns relating to pharmaceutical compounding.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Remediation and Compliance within New FDA Regulatory Framework

 

 

 
 

Client

Mid-size Compounding Pharmacy in the middle of a remediation halt

 

Industry

Pharmaceutical

 

Business Challenge

Compounding pharmacy received two Form 483s. FDA requested a halt on compounding and a recall.

 

Project Timeline

9 months

 

About Registered 503B Outsourcing

On January 8, 2014, FDA issued Dear Colleague and Dear Hospital / Purchaser letters informing them of the passage of new federal legislation that affects the oversight of human drug compounding and to encourage them to consider requiring compounders from which they purchase compounded sterile drugs to register with the FDA as outsourcing facilities.

RemediationOver the course of one year, FDA conducted over 70 inspections of compounding pharmacies across the country, both for cause (42), in response to serious adverse event reports and reports of quality problems, and to proactively (31) identify pharmacies with deficient sterile compounding practices. In most cases, state boards of pharmacy participated in the inspections, some of which were initiated at the request of a state.

 

Client Challenge

A recently registered 503B Sterile Outsourcing Facility was facing serious enforcement action from the FDA: two damaging FDA Form 483 Reports. The FDA-requested cessation of compounding, and an FDA-requested recall of all sterile compounded preparations due to a lack of assurance of sterility created remediation needs. RCA was engaged by the compounding facility as an independent third-party cGMP expert.

 

Approach

RCA experts guided client personnel to develop an effective and robust FDA Form 483 response, performed a thorough baseline cGMP audit under the draft regulations, assisted with additional FDA response communications and ultimately led a certification audit six months after the baseline audit. Although RCA found additional observations during the certification audit, it was able to certify that there remained no further sterility assurance concerns. RCA’s remediation experts prepared and trained facility personnel to assist in their management of the follow-on FDA inspection, and, despite the use of three drug expert investigators by FDA, the firm received only minor, readily correctable FDA Form 483 Observations which were fully addressed by its response.

 

Results

After review by the FDA Dallas District Office and agency officials at the FDA’s Center for Drug Evaluation and Research (CDER), the Agency stated, in writing, that it found no objection to the firm resuming sterile drug compounding operations. With that letter, Unique Pharmaceuticals became one of the first outsourcing facilities to remediate FDA’s sterility assurance concerns relating to the practice of pharmaceutical compounding in general, as well as demonstrate full compliance with the new regulatory framework created by the amendments to the FD&C Act at 503B.

 

About RCA

remediationRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Client

Mid-size Compounding Pharmacy in the middle of a remediation halt

 

Industry

Pharmaceutical

 

Business Challenge

Compounding pharmacy received two Form 483s. FDA requested a halt on compounding and a recall.

 

Project Timeline

9 months

 

About Registered 503B Outsourcing

On January 8, 2014, FDA issued Dear Colleague and Dear Hospital / Purchaser letters informing them of the passage of new federal legislation that affects the oversight of human drug compounding and to encourage them to consider requiring compounders from which they purchase compounded sterile drugs to register with the FDA as outsourcing facilities.

RemediationOver the course of one year, FDA conducted over 70 inspections of compounding pharmacies across the country, both for cause (42), in response to serious adverse event reports and reports of quality problems, and to proactively (31) identify pharmacies with deficient sterile compounding practices. In most cases, state boards of pharmacy participated in the inspections, some of which were initiated at the request of a state.

 

Client Challenge

A recently registered 503B Sterile Outsourcing Facility was facing serious enforcement action from the FDA: two damaging FDA Form 483 Reports. The FDA-requested cessation of compounding, and an FDA-requested recall of all sterile compounded preparations due to a lack of assurance of sterility created remediation needs. RCA was engaged by the compounding facility as an independent third-party cGMP expert.

 

Approach

RCA experts guided client personnel to develop an effective and robust FDA Form 483 response, performed a thorough baseline cGMP audit under the draft regulations, assisted with additional FDA response communications and ultimately led a certification audit six months after the baseline audit. Although RCA found additional observations during the certification audit, it was able to certify that there remained no further sterility assurance concerns. RCA’s remediation experts prepared and trained facility personnel to assist in their management of the follow-on FDA inspection, and, despite the use of three drug expert investigators by FDA, the firm received only minor, readily correctable FDA Form 483 Observations which were fully addressed by its response.

 

Results

After review by the FDA Dallas District Office and agency officials at the FDA’s Center for Drug Evaluation and Research (CDER), the Agency stated, in writing, that it found no objection to the firm resuming sterile drug compounding operations. With that letter, Unique Pharmaceuticals became one of the first outsourcing facilities to remediate FDA’s sterility assurance concerns relating to the practice of pharmaceutical compounding in general, as well as demonstrate full compliance with the new regulatory framework created by the amendments to the FD&C Act at 503B.

 

About RCA

remediationRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

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