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Authorization
The US FDA is authorized to perform inspections involving drug products under the Federal Food, Drug, and Cosmetic Act. For many decades, this primarily involved pharmaceutical manufacturing and associated companies. However, changes were made beginning with the FDA Modernization Act of 1997 (FDAMA97) and the Drug Quality and Security Act (DQSA), passed in 2013, that affected pharmacy compounding and established a new "compounding-manufacturing" hybrid category of outsourcing facilities (503B).
According to DQSA (Sec. 503A Pharmacy Compounding):
"In General.—Sections 501(a)(2)(B), 502 (f)(1) and 505 shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the unsolicited receipt of a valid prescription order or notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient, if the product meets the requirements of this section, and if the compounding...etc."
If the requirements are not met, the exemption does not apply, and the FDA can inspect 503A compounding pharmacies.
Purpose
The purpose of the inspection and any issued Form 483 is to notify the company involved of any objectionable conditions.
Process
At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company's senior management. Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.
Discussion
The Form 483 is a report of observed objectionable conditions but does not include observations of questionable or unknown significance at the time of the inspection. FDA investigators are instructed to note only what they saw during the course of the inspection. Each observation is read and discussed so there is complete understanding of what the observations are and what they mean.
Companies are responsible to take corrective action to address the cited objectionable conditions and any related non-cited objectionable conditions that might exist.
What's Next?
The Form 483 is not a final Agency determination of whether any condition is in violation of the FD&C Act or any of its relevant regulations. All the following are considered by the Agency:
- Form 483,
- Establishment Inspection Report,
- all evidence or documentation collected on-site, and
- any responses made by the company.
The agency considers all of this information and then determines what further action, if any, is appropriate to protect public health.
More next week.
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