Expiration Dating and Stability Testing for Human Drug Products

It’s taking longer than we thought. What happened to Mercurochrome? July 23, Dear Cecil: I had skin surgery recently and was told to apply Mercurochrome to aid in scarless healing. The product, once widely available, is sold by only one vendor in Boise, and I’m told they manufacture their own. Another pharmacist told me they were not allowed to handle or sell it. What happened to this antiseptic that I grew up with? Few under age 30 have ever heard of this stuff. In , the U.

Food Safety Rules and Regulations :: Washington State Department of Health

This article has been cited by other articles in PMC. Abstract Pharmacy compounding involves the preparation of customized medications that are not commercially available for individual patients with specialized medical needs. Traditional pharmacy compounding is appropriate when done on a small scale by pharmacists who prepare the medication based on an individual prescription.

However, the regulatory oversight of pharmacy compounding is significantly less rigorous than that required for Food and Drug Administration FDA -approved drugs; as such, compounded drugs may pose additional risks to patients. FDA-approved drugs are made and tested in accordance with good manufacturing practice regulations GMPs , which are federal statutes that govern the production and testing of pharmaceutical products. In contrast, compounded drugs are exempt from GMPs, and testing to assess product quality is inconsistent.

FDA information on selected cosmetics products, ingredients, and potential contaminants.

Tweet Share Glade is listing the specific fragrance ingredients in each of its products for the first time. Glade The growing trend of revealing ingredients in food products seems to be having an impact on the fragrance industry: The makers of Glade air fresheners have announced that they are now disclosing more information about the chemicals in their products. The company will share the highest ingredient concentrations, down to 0. Fragrance information is notoriously difficult to unearth.

Most ingredients are required to be listed on ingredient labels under the Fair Packaging and Labeling Act , but the FDA does not require companies to disclose their fragrance formulas because the exact makeup of a fragrance can be labeled a trade secret. Complicating the matter is the fact that many companies, including Glade, purchase their fragrances from outside fragrance houses, which closely guard their formulas.

Good Quality Agreements Support Compliance with CGMP

Background[ edit ] Shelf life is the recommended maximum time for which products or fresh harvested produce can be stored, during which the defined quality of a specified proportion of the goods remains acceptable under expected or specified conditions of distribution, storage and display. If the cans look okay, they are safe to use. Discard cans that are dented, rusted, or swollen.

States regulate compounding pharmacies or pharmaceutical companies that mix or compound chemical ingredients into final form. Now FDA regulations also play a regulatory role.

The FDA has also issued warning letters to the following other companies: They have a long way to go. Unfortunately, since Global Herbal Supplies is based in Australia, not the US, it is hard for the FDA to enforce its warnings against non-US companies who make misleading or deceptive marketing claims. In July , a year after the FDA warning letter was sent, Global Herbal Supplies stopped marketing Choraphor and introduced a new product called Dynamiclear, another single-application topical herpes treatment which is very similar to Choraphor in use and application, except for a few different ingredients.

The most common product used to treat cold sores is Abreva docosanol , an FDA-approved topical antiviral product. Abreva has been around for many years. And one of the authors worked for the company that performed the research. The Panel noted that the study was not placebo-controlled, and that both the Dynamiclear and acyclovir treatments appeared to have commenced when, for most of the participants in the study, their cold sores had already proceeded to the stages of blistering, scabbing, or crusting, rather than being applied at the first onset of symptoms.


Supportive Stability Data Number and Size of Batches Initial stability testing by accelerated testing may be performed on a batch smaller than the normal production size as long as the batch is produced by similar equipment as would be used for regular production. Generally, the placing of three initial batches into the long term stability program is considered minimal to assure batch uniformity for establishing an expiration date.

Since a dosage form is a complex unit and there are continued variables in the production process, such as change in personnel, raw material lots and suppliers, and equipment, it is imperative that stability studies are not limited only to initial production batches but a portion of annual production batches be the subject of an ongoing stability program. Accelerated Studies When accelerated stability studies are performed, one batch may be adequate in order to establish a tentative expiration date.

This is acceptable since it is not the purpose of an accelerated test to determine batch uniformity but rather to test for kinetic degradation.

The Food and Drug Administration (FDA, the Agency, or we) is amending certain regulations relating to citizen petitions, petitions for stay of action (PSAs), and the submission of documents to the Agency. In particular, the final rule establishes new regulations to implement certain provisions of.

You may want to read this page first for background. There is no uniform or universally accepted system used for food dating in the United States. Although dating of some foods is required by more than 20 states, there are areas of the country where much of the food supply has some type of open date and other areas where almost no food is dated. Food expiration date coding is a nightmare for the consumer to interpret. There is no standard. Each vendor decides how they want to do it.

The FDA only has guidelines on labeling a product and the required information. This is different from an expiration date on all food products that the consumer can understand. Food products can be divided into two main categories – refrigerated and canned. Most bakery and pharmacy related food items are “sell by” or “best by” dated, which is easy for you and I to understand.

FDA Issues Final Rule on Combination Products cGMPs

Would you be able let us know if there is any guidance regarding re-labeling investigational products at the study site if the IP’s expiry date has been extended? In particular, if instructed by the sponsor can the site staff re-label the study product or are their any other regulations that must be followed? I am aware of only one regulation about expiration dates in the labeling of drug products for investigational use CFR Where new drug products for investigational use are to be reconstituted at the time of dispensing, their labeling shall bear expiration information for the reconstituted drug product.

Access to FDA Safety Data. Adverse Event Reporting System (AERS) AERS collects information about adverse events, medication errors and product problems that occur after the administration of.

It contains no antimicrobial agents. The nominal pH is 5. It allows for drug admixture after connection to a single dose powdered or liquid up to 10 mL drug vial having a 20 mm closure. A breakaway seal in the tube between the vial adaptor and the container is broken to allow transfer of the diluent into the vial and reconstitution of the drug.

The reconstituted drug is then transferred from the vial into the container diluent and mixed to result in an admixture for delivery to the patient. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly.

Solutions in contact with the plastic container can leach out certain chemical components from the plastic in very small amounts. However, biological testing was supportive of the safety of the plastic container materials.

NSLP USDA Foods Product Information Sheets

Current recommendations can be accessed at: Previous BCG vaccination is not a contraindication to tuberculin testing. The skin-test results of BCG vaccinated persons can be used to support or exclude the diagnosis of TB infection. However, an FDA-approved interferon gamma release assay is preferred over tuberculin skin test for persons 5 years of age and older who were previously vaccinated with BCG.

Q: What is Product Dating? Q: Are Retailers Allowed to Sell Products Beyond the Date on A: There are two main types of product dating, “open dating” and “closed dating”. Open Dating uses a .

Right after our hospital began using it I took a look at the product’s package insert and was surprised to discover that the system is for powder filled vials only. Any of Baxter’s approved labeling for the Mini-Bag Plus includes the statement “For use only with single dose drug vials with standard 20 mm closures Our pharmacy had been using the system with a few liquid-filled vials but stopped doing so after discovering that information.

The next time I saw the Baxter rep I asked about it and was told unofficially, of course that some hospitals did indeed use the Mini-Bag Plus with liquid filled vials but that Baxter has concerns that when liquid vials are used it is impossible to know whether or not the entire dose has been transferred from the vial to the bag. This is because if any liquid remained in the vial after the mixing was complete that the person mixing the drug would not know whether or not that liquid was completely or only partially diluted drug.

In other words, did all of the liquid drug enter the bag and become diluted properly, or was there some amount of the drug that never left the vial, leaving the dose in the bag incomplete? The bottom line is that Baxter isn’t sure if the patient will receive the entire dose from a liquid filled vial.


Even though the underlying statute authorizes the standard of identity to include standards for quality, standard of identity regulations primarily address content, not quality. Firms that want to produce a food product that does not have a standard of identity may request petition the agency to set forth a standard of identity see 21 CFR Other entities also are defining food standards:

Food and Drug Administration FDA proposed to tighten the previously proposed expiration dates for oral solid drugs from one year to just six months after they are repackaged into unit doses, except under certain circumstances. 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”. Compliance Policy Guide In addition, once final, it will supersede Compliance Policy Guide Comments regarding the draft document should be submitted within 60 days of publication. In the previous draft guidance on expiration dating issued in May , the FDA had proposed to set the expiration date for nonsterile, unit-dose repackaged drugs to one year, which was also aligned with USP standards at the time for beyond use dating for unit-dose repackaging by dispensers.

The 7-paged guidance does not cover Other dosage forms e. The FDA also proposes to permit the expiration date to exceed the ones described above, provided the above-listed conditions are met and if repackagers have supportive data from appropriate studies including a risk-based assessment , using an adequate number of samples. These samples need to demonstrate that the container closure system used for repackaging is at least as protective for the drug product as the original packaging.

Medical Device Shelf Life Determination

In recent years, FDA regulated companies have been increasingly pulled up by the Agency for failing to follow regulations, especially those governing manufacturing and branding of products. Irrespective of the size of the business, FDA compliance training is essential to ensure adherence to the industry guidelines and to ensure the products do not pose any risk to the consumer or public. Federal agency responsible for protecting public health. FDA regulates a wide range of products including food, dietary supplements, pharmaceutical drugs, vaccines, blood transfusions, medical devices, electromagnetic radiation emitting devices ERED , cosmetics, and veterinary products.

Is it required that the label on an investigational drug vial have a drug expiration date printed on it? FDA issued a guidance several years ago entitled “Guidance for Industry: This guidance explains that FDA expects investigational drug products that will be used in human subjects to be manufactured in compliance with good manufacturing practices CGMPs. Generally, to be in compliance with CGMPs, drug products must bear certain information on the product labeling, such as control numbers or lot numbers and expiration dates.

However, in the case of investigational drug products, FDA recognizes there may be instances when including this information on the product labeling might have an adverse impact on the “blinding” of the product. So FDA permits excluding control numbers and expiration dates from the product labeling for “blinding” purposes, provided this information is made available separately, for example, to the clinical investigator should the blind or randomization code need to be broken.

Stability information should be available when the product is shipped from the sponsor to the clinical study site.

The World Tonight: FDA to enforce expiration dates on goods