Tuesday, August 20, 2013


For those who missed it in July...

Patient Safety: GPhA supports the goal of clarifying FDA’s authority over compounding in order to protect patient safety and prevent another public health crisis.

Traditional Compounding: Traditional compounding plays a vital role for patients, and any new regulation should maintain that role. Pharmacy compounding should adhere to the standard of "one patient, one prescription, one drug."

Good Manufacturing Practices - Sterile Products: The FDA’s regulations for pharmaceutical manufacturers are based on the principle that quality cannot be inspected or tested into a finished product, but quality must be designed into the product and manufacturing processes. cGMP regulations establish the regulatory framework in the U.S. as the blueprint for assuring safety and efficacy. The large-scale manufacture of sterile medicines – no matter who performs this function – must involve similar activities as they have similar potential for risk, and should therefore be regulated in a consistent, risk-based manner. All large-scale manufacturers of sterile injectable medicines should be required to prove that they can manufacture these medicines consistently and safely, through documentation to the FDA and submitting to both preapproval and routine risk-based cGMP inspections. A sterile injectable drug should not be the object of compounding, unless these aforementioned regulations and guidances are enforceable by the FDA or if the products are compounded for a specific individual patient, per a physician prescription.

Bulk Drug Substances: GPhA strongly supports establishing standards for the quality of the bulk substances used in compounding.

Drug Shortage Exemption: To solve a drug shortage by lowering safety and quality standards is not in the best interest of the public health. Any drug shortages exemption should also clarify that sterile products on the drug shortage list cannot be compounded indefinitely.

Notification Prior to Compounding: GPhA strongly supports a requirement for large-scale compounding pharmacies and "compounding manufacturers" who plan to compound a marketed drug on the shortage list to notify FDA prior to the start of compounding.

Pre-marketing Registration, Inspections & Fees: GPhA believes that large-scale compounders and "compounding manufacturers" should be subject to pre-marketing inspections by FDA, and FDA should be provided with the resources needed through fees on these large-scale compounders or "compounding manufacturers."

Labeling: In the interest of providing physicians and patients with complete information, any product compounded outside of the institution in which it will be administered should be labeled as a compounded product.

Adverse Event Reporting: Large-scale compounding pharmacies and "compounding manufacturers" should be required to report adverse events to FDA


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