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We will continue looking at the FDA's approach for the 503B Outsourcing Facilities regarding essentially copies. The Guidance, released in January 2018, is arranged as follows:
- INTRODUCTION AND SCOPE
- BACKGROUND
- Section 503B of the FD&C Act
- Compounding, Generally
- Compounded Drugs that are Essentially Copies of Approved Drug Products
- Compounded Drugs that are Essentially Copies of Unapproved Non-Prescription Drug Products
- POLICY
- Definition of Essentially a Copy of an Approved Drug
- Recordkeeping
APPENDICES A & B
This week, we will look at the highlighted sections in the BACKGROUND section above as an aid in understanding the position of the FDA.
C. Compounded Drugs that are Essentially Copies of Approved Drug Products
- As with all compounded drugs, drugs compounded by outsourcing facilities have not undergone FDA premarket review for safety, effectiveness, and quality, and lack a premarket inspection and finding of manufacturing quality that is part of the drug approval process.
- Because they are subject to a lower regulatory standard, compounded drugs should only be distributed to healthcare facilities or dispensed to patients to fulfill the needs of patients whose medical needs cannot be met by an FDA-approved drug.
- The restrictions on compounding drugs that are essentially copies of approved products ensure that outsourcing facilities do not compound drug products under the exemptions in section 503B for use in patients who could use an approved product. Compounding copies of these products would unnecessarily expose patients to drug products that have not been shown to be safe and effective.
- In addition to these immediate public health risks, section 503B's prohibition on producing a drug product that is essentially a copy of an approved drug product protects the integrity and effectiveness of the new drug and abbreviated new drug approval process.
D. Compounded Drugs that are Essentially Copies of Unapproved Non-Prescription Drug Products
- The definition of essentially a copy of an approved drug in section 503B(d)(2) also refers to non-prescription drug products. Congress did not provide exemptions under section 503B for such drugs, which ensures that outsourcing facilities do not compound unapproved over-the-counter (OTC) drug products under the exemptions in section 503B.
- Such products may only be produced under the requirements that apply generally to conventional drug manufacturers. Section 503B also protects FDA's OTC drug monograph process. FDA has an ongoing process to evaluate the safety and effectiveness of OTC medications, and if the Agency determines that an OTC drug meeting certain conditions is generally recognized as safe and effective, it will publish a final monograph specifying those conditions.
- Compounding copies of such drug products would undermine the OTC drug monograph process under which drug manufacturers must comply with the published monograph, which includes a set of specific regulatory requirements that limit the formulation of the drug product, and both the content and format of its labeling.
A complete copy of the Guidance can be obtained at:
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatory
information/guidances/ucm510153.pdf
Just a reminder, this is for 503B Outsourcing Facilities, NOT traditional 503A pharmacies.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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Tip of the Week
Fortunately, our country survives and thrives not on the efforts of politicians but in spite of them. Our country survives because of the hard work of its citizens and the desire to continue to live in a free country. Hopefully, one day, politicians will wake up and realize that "they" are not what it's all about�it is the citizens and the standards upon which America was founded!
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