Do you have stability studies to justify your expiration dating beyond-use date on repackaged drugs? Do you know what class of packaging materials you use? Do you have a separate quality team overseeing your packaging operation? Proposed changes in pharmacy packaging requirements could have a significant impact on your operations and budget. Shorter dating and more regulations could mean more time spent on packaging, more waste due to shorter dating, more personnel needed for packaging and higher costs. Lower your risk. Improve medication safety.
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Submit written or electronic comments on the draft guidance by August 29, General comments on agency guidance documents are welcome at any time. Send one self-addressed adhesive label to assist that office in processing your requests.
Specifically, the draft guidance states certain circumstances under which we intend to exercise enforcement discretion and do not intend to take action against repackagers for failure to conduct stability studies to support expiration dates for drug products in accordance with FDA regulations. The draft guidance is a proposed revision of section We originally issued CPG b.
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products Draft Guidance for Industry August Download the Draft Guidance Document Read the Federal Register Notice Draft. 66 For solid oral dosage form drugs repackaged into unit-dose containers, FDA does not intend to 67 take action regarding the requirements of §§ and (i.e., expiration dating Shortens the expiration date to be used under certain conditions for solid oral dosage forms repackaged in unit-dose containers from 12 months to 6 months or 25 percent of the time remaining until the expiration date on the container of the original manufacturer's product.
This expiration dating ensures the drugs' safety and efficacy over their intended shelf life. CPG b.
Since its adoption inthe CPG has stated that, in light of the USP standards and under certain conditions, the agency does not deem it necessary that stability studies be conducted on drugs that are repackaged into unit-dose containers. Therefore, the CPG has stated that we do not intend to initiate enforcement action against any unit-dose repackaging firm for failure to have stability studies supporting expiration dates, provided certain conditions are met, including that the expiration date does not exceed 6 months.
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At the time the CPG was adopted, this recommendation was substantially comparable to the USP standards on expiration dating of nonsterile unit-dose repackaged drug products. Inthe USP revised its standards on the beyond-use dating of nonsterile solid and liquid dosage forms that are packaged in single-unit and unit-dose containers.
Jan 14, Do you have stability studies to justify your expiration dating (beyond-use date) on repackaged drugs? FDA guidelines suggest six months dating (or 25 percent of the remaining manufacturer expiration date, whichever is less) in the absence of a risk-based approach to stability studies. Do you know what class of packaging materials you use? May 31, The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ''Expiration Dating of Unit- Dose Repackaged Drugs.'' The draft guidance is a proposed revision of section of FDA's Compliance Policy Guide (CPG) (CPG b). We are proposing to revise. Mar 10, The expiration date on the large container. The BUD of 6 months agrees with the time frame for expiration dating stated by FDA in a decades-old compliance policy guide for unit dose repackaging firms, said Dennis Tribble, an expert in pharmacy operations automation who works for medical device maker BD.
The USP now states that, for such products, the beyond-use date must be 1 year from the date the drug is packaged into the single-unit or unit-dose container or the expiration date on the manufacturer's container, whichever is earlier, unless stability data or the manufacturer's labeling indicates otherwise USP 27, General Notices and Requirements, at We have considered the USP revision to its beyond-use standard and believe that similar conditions are appropriate for CPG b.
We believe that under certain specified conditions, it may be appropriate to assign up to a one-year expiration dating period to solid and liquid oral dosage form drug products repackaged into unit-dose containers, without conducting new stability studies on the repackaged drug products.
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Therefore, we are proposing to revise CPG b. Under draft revised CPG b.
Expiration Dating of Unit Dose Repackaged Drugs Use the 1/4 method to determine the expiration date of a medication repackaged on: March 10, The stock bottle expiration date is 3/
These other conditions include, but are not limited to, standards for containers, repackaging operations, and the repackaging environment. Additionally, because CPG b. We invite comments on the draft guidance. Additionally, we intend to conduct further study of the appropriateness of the proposed revision of CPG b.
We do not intend to make a final decision on the proposed revision of CPG b. We invite interested persons to submit data establishing appropriate expiration dating for such drug products.
The draft guidance, when finalized, will represent the agency's current thinking on expiration dating on nonsterile unit-dose repackaged drug products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
An alternative approach may be used if such approach satisfies the current requirements of the applicable statutes and regulations. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.
A company that wishes to repackage medications must be licensed by the FDA and the Florida Dept of Health as a Repackager 3. FDA good manufacturing standards require that repackaged medications have a MAXIMUM expiration date of 6 months unless stability testing has been completed. The draft CPG specifies certain conditions when it may be possible to assign up to month expiration dating to nonsterile solid and liquid oral drug products repackaged into unit-dose containers. The expiration date does not exceed six months; and The six month expiration period does not exceed 25 per cent of the remaining time between the date of repackaging and expiration date shown on.
Comments are to be identified with the docket number found in brackets in the heading of this document. The draft guidance and received comments may be seen in the Division of Dockets Management between 9 a.
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Expiration dating of unit-dose repackaged drugs
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FDA guidelines suggest six months dating or 25 percent of the remaining manufacturer expiration date, whichever is less in the absence of a risk-based approach to stability studies. USP Class A materials can support one year dating with stability studies.
USP Class B materials can only support six months dating. USP Class D materials can only support 30 days dating. Proposed FDA guidelines ensure packaging and dating consistency regardless of location.
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FDA requires proof that products have not been packaged on the same equipment without validation of cleaning. Packaging materials must comply with FDA guidelines for water vapor and light transmission.
Canisters in packaging machines should be proven as capable to protect the stability of the product while in storage. Canisters would be considered a container closure system and comply with USP requirements for light resistance.
Shorter dating. More waste.