"Compounders" and "compounding manufacturers" defined
On May 22, 2013, the Senate’s Health, Education, Labor and Pensions (HELP) Committee approved S. 959, legislation intended to replace section 503A of the federal Food, Drug & Cosmetic Act, as well as to expand the authority of the U.S. Food and Drug Administration (FDA) to regulate pharmacy compounders and their products. With its approval by the HELP Committee, the bill can advance to the Senate for a full vote. [Editor's note: See our related story: "Senate panel approves compounding bill, May 24, 2013.]
Compounding manufacturers defined
Among other things, the proposed legislation creates two categories of compounding pharmacies: “traditional compounders” and “compounding manufacturers.”
A compounding manufacturer:
Â Makes sterile drug products without receiving, or in advance of receiving, a prescription, and introduces those drugs in interstate commerce; or
Â Repackages a drug using sterile preservative-free single-dose vials or by pooling sterile drugs. Compounding manufacturers would be subject to the FDA current Good Manufacturing Practices (cGMP) applicable to drug manufacturers. Certain exemptions are available depending on circumstances.
Compounding manufacturers must:
Â- Require a pharmacist to oversee the operations of the compounding manufacturer;
Â- File with FDA every six months a list of drugs compounded during the previous six-month period;
Â- Report to FDA serious adverse drug experiences within 15 days after receipt of information and maintain these records for 10 years;
Â- Comply with specified labeling requirements for the compounded drugs;
-Â Pay registration fees and re-inspection-related costs to FDA.
Traditional compounders defined
On the other hand, a “traditional compounder” means a licensed pharmacist in a state-licensed pharmacy that compounds a drug:
Â- Upon receipt of a prescription for an individual patient; or
- In limited quantities before receipt of a prescription for an individual patient, if there is an “established history” of such prescriptions.
Compounded drugs meeting these requirements appear to be exempt from the proposed legislation.
In addition, if a pharmacy located in a “health system” is engaged in compounding and dispensing within that health system (even if interstate), it is deemed a traditional compounder and is generally exempt from the proposed legislation.
FDA surprise inspections
FDA has published a “2013 FDA Pharmacy Inspection Assignment” in which it described its new, recently undertaken nationwide inspections of select sterile compounding pharmacies. Its objective was to determine whether certain pharmacies “posed a significant threat to public health from poor sterile production practices.”
FDA inspected 29 pharmacies using its own established “risk criteria.” The whirlwind inspections were conducted from February to April 2013 across 18 states. The overwhelming majority of inspections were conducted in concert with state pharmacy boards. In the process, FDA interviewed pharmacy technicians, collected information on pharmacy operations and standard operating procedures, and collected select product samples with which to run sterility and stability tests. FDA also reviewed potency, sterility, and endotoxin failures, and undertook sterile-room air-flow studies.
Even though the entities are classified as pharmacies, FDA inspectors undertook evaluation “according to federal standards regarding aseptic practices.” Most of the inspected pharmacies were issued FDA observations in the form of FDA Form 483s.
Some of the Form 483 observations publicized by FDA in its inspections included: “incomplete and/or inadequate drug product batch failure investigations, inappropriate and/or inadequate clothing for sterile processing, lack of appropriate air filtration systems, insufficient microbiological testing,” and “practices” thought to “create a risk of contamination.”
FDA appears to have used this data to help persuade Congress that stronger FDA oversight of sterile compounding pharmacies is required.