FDA Outlines Conditions for Pharmacies to Repackage Drug Products
Beyond use dates are different from expiration dates. Expiration dates are required on commercially manufactured products and are determined after extensive study of the product’s stability. Most expiration dates are given in years for commercial products. Beyond use dates are used for compounded preparations and are generally in days or months. The major problem for pharmacists is that the stability of compounded formulations often is not known. Also, Many instabilities cannot be detected without the use of analytic equipment. This is in contrast to incompatibilities that can be visually observed. It is not possible to use a manufacturer’s expiration date and extrapolate or estimate a beyond use date for a compounded formulation. The compounded formulation probably will not be identical to the manufactured product; it may have a different drug concentration, use different diluents, be a different fill volume, and be packaged in a different container type. When an official monograph isn’t present, a systematic approach to assigning the date can be as follows:.
Beyond-Use and Expiration Date Differences
Unit-dose Packaging. Linda F. The unit-dose packaged medication system has been available since the s; however, it has become a standard of practice for health-systems in the U.
The objective of an expiry date of a medication is to provide a Liquids, oral. 28 Days.
A guidance issued by FDA on January 12 makes clear that the agency does not favor some long-standing habits of pharmacy personnel related to the repackaging of drug products. Take, for example, the beyond-use date BUD for tablets taken from a manufacturer’s large container and repackaged into smaller containers.
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. But referencing the date of the original container’s first opening in determining the BUD is not what pharmacists usually do when repackaging tablets or capsules, he said. Tribble, expressing his own opinion and not that of his employer, said “FDA doesn’t see any difference—or doesn’t appear to see any difference—between perforation of a [sterile] vial for removing its contents and the opening of a bottle of pills.
That regulatory view by FDA agrees with what the agency has said over time, he said. Jillanne M. Schulte, ASHP’s director for federal regulatory affairs, said FDA views the activity of repackaging a drug product as a manipulation that presents a risk and fits into the “larger discussions” about the quality of drug compounding. A guidance specific to biological products, such as therapeutic monoclonal antibodies, is in the works.
A draft guidance on the compounding and repackaging of radiopharmaceuticals by state-licensed nuclear pharmacies was released in December. Footnote 13 in the January 12 guidance on drug product repackaging by pharmacies suggests that the agency may develop a version specific to hospitals and health systems. The footnote reads as follows: “FDA is considering the applicability of the policies described in this guidance to hospitals and health systems and intends to address these issues in separate guidance.
Schulte described ASHP as “cautiously optimistic” that FDA will release repackaging guidance specific to the hospital and health-system settings.
Updating formulations for compounded oral liquid medications in a university health system
The U. The FDA states that this action was taken in response to ” an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose. The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products “.
In addition, once final, it will supersede Compliance Policy Guide Comments regarding the draft document should be submitted within 60 days of publication.
This 1-year date is referred to as the beyond-use date. to authorize the use of certain lots of oseltamivir for oral suspension (Tamiflu, Genentech) Liquids can be inspected for unusual discoloration, in addition to precipitate.
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FDA Draft Guidance on Expiration Dating of Unit-Dose repackaged Solid Oral Dosage Forms
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Orange Book Archives. FDA is still considering applicability of these policies to hospitals and healthcare systems, which it intends to address in yet another guidance document. FDA also issued a separate revised draft guidance document on repackaging of biological products, which will be the subject of a separate blog post. The Agency states, for example, that if tablets are removed from a blister pack and placed in a different container, then that would be considered repackaging.
However, if the blister packs are placed into a different container for later use leaving the blister packs intact then that would not be repackaging. Repackaging may alter the characteristics of drug products in ways that FDA did not consider during the drug approval process, affecting stability, safety and efficacy. Some highlights of the guidance include:. Palmer —. The drug must be repackaged by a state-licensed pharmacy, federal facility or outsourcing facility, and under the direct supervision of a pharmacist.
If repackaged by a pharmacy or federal facility but not an outsourcing facility , the drug must be pursuant to a prescription or order for an individually identified patient. Except for single-dose vials, the drug must be repackaged in a way that does not conflict with approved labeling. However, the guidance notes unlike the draft that the repackaging must be in accordance with the handling or storage instructions for the approved product so as to not conflict with approved labeling.
The most significant changes between the draft and final guidance address beyond use dating BUD for repackaged products: Sterile drug products repackaged by state-licensed pharmacies or federal facilities If the repackaged product is an FDA-approved drug product with a specified in-use time , then the repackaged drug must be assigned a BUD that is established in accordance with the in-use time on the product or the expiration date on the product, whatever period is shorter.
If the drug is a non-sterile product repackaged by a state licensed pharmacy, federal facility, or outsourcing facility : For an FDA-approved product with a specified in-use time, then the repackaged drug must be assigned a BUD that is established in accordance with the in-use time on the product, or the expiration date on the product, whatever period is shorter.
3 Current good manufacturing process and current good cumpounding practices
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A beyond-use date is a date placed on a prescription by a pharmacy for compounded medications they prepare, noting when that prescription should no longer be used. This date is determined by the pharmacy when they prepare a compound prescription based on different factors, including:. The beyond-use date is different than an expiration date of a drug.
This includes moving a medication to a different container, which is the normal practice for pharmacies dispensing prescriptions. Based on the type of drug, how fast it degrades, dosage, type of container, storage conditions, prescription length, the likelihood of contamination. Based on testing a drug in specific conditions related to storage containers, lighting, temperature, etc. The FDA says it’s dangerous to take medications after their expiration date because they may not be as effective, their chemical composition may have changed, or they may have deteriorated to a point where harmful bacteria could breed.
Particularly with antibiotics, it’s important to watch the expiration date because using an expired antibiotic means it may not be potent enough to completely treat your infection, leaving you at risk for a worse one.
Advice for when parents ask about expired medicine
This reduces the volume of the blood, decreasing peripheral vascular resistance. Hydrochlorothiazide belongs to the thiazide class of diuretics, acting on the kidney to reduce sodium Na reabsorption in the distal convoluted tubule. This reduces the osmotic pressure in the kidney, causing less water to be reabsorbed by the collecting ducts. HCT is often used to treat hypertension, congestive heart failure and symptomatic edema.
It is effective in diabetes insipidus and is also sometimes used in hypercalciuria.
Basics of Sterile Compounding: Criteria for Determining Beyond-use Dating Comparative Stability of Vitamin K1 Oral Liquids Prepared in Sterile Water for.
Change to read:. The immediate container is that which is in direct contact with the article at all times. The closure is a part of the container. Prior to being filled,the container should be clean. Special precautions and cleaning procedures may be necessary to ensure that each container is clean and that extraneous matter is not introduced into or onto the article. The container does not interact physically or chemically with the article placed in it so as to alter the strength,quality,or purity of the article beyond the official requirements.
The Pharmacopeial requirements for the use of specified containers apply also to articles as packaged by the pharmacist or other dispenser,unless otherwise indicated in the individual monograph. Articles intended for sale without prescription are also required to comply with the tamper-evident packaging and labeling requirements of the FDAwhere applicable.