Expiration Dating for Unit-Dose Repackagers
Ruling puts patients at risk and FDA-registered unit-dose repackagers at a disadvantage.
|Eugene S. Peiser|
Peiser & Associates Inc.
Earlier this year, Peiser & Associates (Palm Harbor, FL), a firm representing FDA-registered drug repackagers, filed a citizen petition requesting that FDA revise its policy on expiration dating of unit- dose repackaged drugs. This would allow firms that are legally registered and inspected by FDA to use the 12-month expiration date. It would also help "level the playing field" so that registered drug repackagers do not lose business to noncompliant repackagers that operate outside FDA's scrutiny. Furthermore, the requested amendment will help protect patient health by ensuring that unit-dose drugs are repackaged in compliance with FDA regulations.
FDA's guideline states that unit-dose repackaging firms are not re-quired to perform stability studies, as long as their USP-compliant packaging carries an expiration date that doesn't exceed six months. That expiration period should not exceed 25% of the remaining time between the repackaging date and the manufacturers expiration date on the original unopened container. The 24th edition of the USP revised the six-month expiration date to 12 months.
According to the citizen petition filed by Peiser & Associates, this guideline places FDA-registered and inspected repackaging firms at a distinct disadvantage. FDA-registered repackagers are losing business to nonregistered facilities. Most clinics, pharmacies, and hospitals do not follow the controls required by the FDA-registered facilities and are therefore able to place a 12-month expiration date on repackaged drugs. Because these facilities do not provide the controls or protection afforded by FDA-registered packagers, the opportunity for mistakes, mix-ups, or cross-contamination of the drugs is much greater. Firms registered with FDA, on the other hand, must follow strict rules and regulations including CGMPs. These rules and regulations provide a much stricter safeguard for the protection of the public. Furthermore, FDA routinely inspects registered repackagers, whereas drug stores, clinics, hospital, and long-term nursing homes are not subject to such inspections and controls and can repackage drugs without adequate safeguards.
FDA-registered repackaging firms routinely receive drugs from hospitals and clinics. These drugs are then repackaged into unit-dose packaging for convenience and to ensure accurate dosing for the patient. Therefore, these regulated repackagers are performing the same task as these other facilities but with greater quality assurance. However, because they are operating under much tighter control and security, they are incurring more costs than back-room operators and must charge accordingly in order for services to remain profitable.
Many of the back-room repackaging operations are using packaging materials that are not equal to those required by FDA-registered firms. The repackaged drug products are not tested for light transmission resistance or tight container system (leakers), and there is no guarantee that the repackaged drug product meets its required parameters. Drug products repackaged by FDA-registered firms provide a much greater degree of safety to the public.
In addition, hospitals and clinics that use outside packaging services prefer to receive at least a one-year expiration on repackaged drugs. This will lead to many FDA-regulated repackagers ceasing operation because they are unable to provide a one-year expiration date on the repackaged unit-dose drug products.
For these reasons, the FDA ruling is detrimental to a patient's health. Patients may be receiving a repackaged drug product that does not meet all parameters required, and therefore proper treatment may not be provided.
Eugene S. Peiser, Doctor of Pharmacy, is a consultant with Peiser & Associates Inc. He can be reached at 800/367-4313 or firstname.lastname@example.org.