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FAQ

1. What is FDA compliance, and why is it important?

FDA compliance refers to adhering to the regulations set by the U.S. Food and Drug Administration (FDA) to ensure the safety, efficacy, and quality of products like pharmaceuticals, medical devices, cosmetics, and more. It's crucial for companies to maintain compliance to avoid legal issues, product recalls, or being barred from selling their products.

2. What is a 503B outsourcing facility?

A 503B outsourcing facility is a specialized compounding pharmacy that prepares sterile drugs in bulk without individual prescriptions. These facilities are highly regulated by the FDA and must comply with stringent guidelines, including facility registration, product reporting, and meeting good manufacturing practices (GMP).

3. What is an FDA Form 483, and how should we respond to it?

An FDA Form 483 is issued after an FDA inspection when inspectors observe conditions that may violate the Food, Drug, and Cosmetic (FD&C) Act. It’s essential to respond to a Form 483 promptly and thoroughly, addressing each observation with corrective actions. Pharma Compliance Professionals can assist in preparing an effective response and ensuring remediation.

4. What are the requirements for OTC drug labeling compliance?

OTC (Over-the-Counter) drug labeling must comply with FDA requirements under the OTC Monograph system. This includes clear labeling of active ingredients, usage instructions, warnings, and other essential product details. Failure to comply can lead to product recalls or fines. We provide full label review services to ensure compliance.

5. How does MOCRA impact cosmetic companies?

MOCRA (Modernization of Cosmetics Regulation Act) introduced new regulations for the cosmetic industry, such as ingredient disclosure, labeling requirements, and post-market surveillance. Compliance with MOCRA is critical for launching and marketing cosmetic products in the U.S. Pharma Compliance Professionals can help companies navigate these new regulations and avoid delays.

6. What is an ANDA, and how can it help my company?

An Abbreviated New Drug Application (ANDA) is a submission to the FDA for the approval of a generic version of an already approved brand-name drug. An ANDA application shows that the generic drug is bioequivalent to the original. We provide support for the entire ANDA submission process, from preparation to FDA communication, to ensure your generic drug reaches the market.

7. What are cGMP and cGLP, and why are they important?

cGMP (current Good Manufacturing Practices) and cGLP (current Good Laboratory Practices) are FDA regulations that ensure products are consistently produced and controlled according to quality standards. These guidelines are vital for maintaining product quality, safety, and compliance with FDA requirements. Regular audits and risk assessments are essential, and we help businesses stay compliant through assessments and remediation services.

8. What are Certificates of Pharmaceutical Product (CPP), and why do I need them?

CPPs are documents issued by regulatory agencies that certify the compliance of pharmaceutical products with current regulations, often required when exporting drugs to certain countries. Pharma Compliance Professionals can assist in obtaining these certificates to ensure smooth international operations for your business.

9. How does post-market surveillance work in the pharmaceutical and cosmetic industries?

Post-market surveillance refers to the monitoring of a product after it has been released to the market to ensure ongoing safety and compliance. This includes tracking adverse events, product complaints, and ensuring the product continues to meet regulatory standards. Pharma Compliance Professionals help companies set up and maintain post-market surveillance systems to avoid regulatory penalties.

10. What are the key steps in FDA audit preparation?

Preparing for an FDA audit involves:

  • Conducting internal mock audits to identify areas of potential non-compliance.

  • Ensuring that documentation, such as Standard Operating Procedures (SOPs), is up to date and accessible.

  • Training staff to follow compliant practices.

  • Developing a plan for responding to potential observations or citations, such as FDA Form 483.
    Pharma Compliance Professionals offers full FDA audit preparation services to ensure you are fully compliant before inspection.

11. What is the process for drug establishment registration?

Drug establishment registration is required for any company involved in the manufacturing, preparation, propagation, or processing of drugs in the U.S. This includes both domestic and foreign companies. Pharma Compliance Professionals assists with facility registration, NDC code acquisition, and ensuring all information is submitted to the FDA.

12. How can Pharma Compliance Professionals help with SOP development?

Standard Operating Procedures (SOPs) are essential for ensuring consistent and compliant practices across your business. We help companies develop, maintain, and update SOPs in alignment with FDA regulations, covering everything from manufacturing to documentation practices.

13. What is the difference between IND and ANDA applications?

  • IND (Investigational New Drug): This is for experimental drugs undergoing clinical trials before they are marketed. The IND allows a company to legally ship an experimental drug across state lines.

  • ANDA (Abbreviated New Drug Application): This is for a generic version of an already approved drug. It doesn’t require clinical trials, just proof that the generic is bioequivalent to the original.

Pharma Compliance Professionals assists with both IND and ANDA applications to ensure timely and successful submissions.

14. Why is FDA labeling review critical for my product?

Accurate labeling ensures that your product is marketed legally in the U.S. and meets the FDA's stringent requirements. Incorrect or incomplete labeling can result in product recalls, delays, and fines. Our labeling review services ensure that your product’s packaging is fully compliant with FDA standards.

15. What tools and platforms do you use to support clients?

We leverage tools like Google Analytics, LinkedIn, Google Ads, Squarespace, and compliance management systems to provide a comprehensive, data-driven approach to your compliance needs. This helps us track performance, manage tasks, and deliver timely results to our clients.