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It is an opportunity for us to reflect on the language and ideas that represented each year. So, take a stroll down memory lane to remember all of our past Word of the Year selections. Change It wasn’t trendy , funny, nor was it coined on Twitter , but we thought change told a real story about how our users defined Unlike in , change was no longer a campaign slogan. But, the term still held a lot of weight. Here’s an excerpt from our Word of the Year announcement in The national debate can arguably be summarized by the question: In the past two years, has there been enough change? Has there been too much? Meanwhile, many Americans continue to face change in their homes, bank accounts and jobs.

USFDA Guidelines for Pharmaceuticals

For VCU Medical Center, a bed hospital in Richmond, Virginia, outsourcing some of our packaging needs presented an efficient and cost-effective solution to managing our packaging workload. We decided to outsource repackaging of several oral liquids not available in unit dose form since packaging these items onsite was labor intensive and time consuming.

Inventory Management Challenges While outsourcing provides numerous benefits, it also can pose some inventory management challenges. Anticipating potential issues and implementing a solid system to manage this process will help ensure optimal inventory.

(f) All medications repackaged by the pharmacy shall be labeled with an expiration date, name and strength of drug, lot number, date of issue, manufacturer’s name if generic, and cautionary and/or accessory labels, in accordance with N.J.A.C. ‐, United States.

Unit Dose Pharmaceuticals The decision to repackage bulk, oral-solid medications in-house or purchase these drugs in unit-dose form is a central consideration when ensuring patients receive high-quality, cost-effective medications. Both methods offer advantages and disadvantages depending on the size of the hospital and its individualized needs; while hospitals that require a limited amount of packaging may do well repackaging bulk products in-house, facilities that utilize higher volumes may benefit from purchasing pre-packaged, bar coded, unit-dose medications from an outsourcer.

The hospital currently relies on a decentralized drug distribution model, utilizing medication carousels, an automated narcotic management system, automated anesthesia carts in the operating rooms, and ADCs on the units. At that time, we utilized an older-model machine to repackage medications on a per-patient basis. Medications were packaged and dispensed by patient in a single strip, and then stocked by patient in secure carts located in each nursing unit. Unfortunately, the repackaging machine did not include bar-coding capabilities, nor did it interface with the other pharmacy information systems.

As a result, our ability to monitor inventory and improve efficiency was severely limited. Eight years ago, in a quest to create a more holistic, automated system, we switched to decentralized distribution supported by ADCs stocked by drug, rather than by patient. With this change, we can now rely on the in-depth reporting capabilities of our ADCs to drive increased efficiencies in inventory and usage.

To support this approach, we decided to focus on purchasing the majority of our medications in bar-coded, unit-dose form, rather than make the investment in upgrading our repackaging operation. Those medications that are not available in unit dose from the manufacturer are repackaged in-house using a small, tabletop packaging machine.

A History: ’s Word of the Year

It is not applicableto disinfectants, drug products for veterinary use, drug products used in clinical trials, drug products regulated solely as natural health products subject to the provisions of the Natural Health Products Regulations, and radiopharmaceuticals and biological drug products as listed in Schedules C and D of the Food and Drugs Act.

This guidance document contains: The examples provided in this guidance are for illustrative purposes only and do not represent actual drug products. This guidance document came into effect in , was subsequently revised in , and has since been removed from circulation by Health Canada because much of its content was deemed to be out-of-date. The purpose of this document is to provide guidance to sponsors to facilitate compliance with the labelling requirements pursuant to sections 3, 9, and 10 of the Food and Drugs Act as well as related provisions of the Food and Drug Regulations, the Controlled Drugs and Substances Act, and its related Regulations including the Narcotic Control Regulations, Parts G and J of the Food and Drug Regulations and the Benzodiazepines and Other Targeted Substances Regulations.

This guidance should be used in conjunction with any other relevant Health Canada guidelines, policies and technical documents.

For more than 45 years, the Medi-Dose System has been used by facilities of all sizes to package solid oral, unit dose medications. Working with pharmacists and technicians, Medi-Dose has been designed to be the easiest, fastest and most cost-effective way to unit dose and bar code your inventory.

Hold the specimen at for 1 minute. Quickly cool the specimen to room temperature, and reheat it to at a heating rate of about 5 per minute. Quickly cool the specimen to room temperature, and reheat it to at a heating rate of about 10 per minute. Apply the closure firmly and uniformly each time the bottle is closed. Weigh each empty bottle and its closure. Record the weight of each bottle and its closure, and determine the average bottle volume, in L, taken by the following formula: Using a pipet, adjust the water level in the bottles to the fill point.

The bottles so tested meet the requirements and are tight containers if the water vapor permeation rate exceeds mg per day per L in not more than 1 of the 10 test bottles and exceeds mg per day per L in none of them. Cut a relatively flat portion from the side wall of one bottle, and trim it as necessary to fit the sample holder of the spectrophotometer. Obtain the visible spectrum of the side wall by scanning the portion of the visible spectrum from to nm.

Determine, to the nearest 2 nm, the wavelength of maximum absorbance. Fit the bottles with impervious seals, such as aluminum foil, and apply closures.

Challenge Accepted

Are such auto-calibration procedures acceptable instead of external performance checks? If not, then what should the schedule for calibration be? The auto-calibration feature of a balance may not be relied upon to the exclusion of an external performance.

Expiration dating of unit-dose repackaged drugs compliance policy guide () Under the jcaho’s medication system must be submitted within 60 days of unit-dose repackaged solid oral dosage form drug evaluation and. Standards, when finalized, will not .

Medications are pre-measured into specific doses to reduce or eliminate the risk of a dose being measured incorrectly. Patients are charged for only the medications that they actually receive and not charged for an entire bulk bottle. Each dose can be barcoded to allow for new technologies, such as patient bedside scanning and electronic chart documentation. Unit-dose packaging is often not very profitable for the drug manufacturers, and hundreds of common drugs are not commercially available in unit-dose packaging.

Fortunately, there are several options available for unit-dose packaging drugs from bulk bottles: Pharmacy administrators need to evaluate the needs of their facilities and choose the best option to meet those needs. Automated Unit-dose Packaging Systems Automated unit-dose packaging systems can be advantageous for large and small facilities. When the inventory drops to a certain level from an inventory area or the dispensing cabinets, it sends a message to the automated unit-dose packaging system, and the machine packages only what the area or cabinet needs with barcodes that are readable by the hospital operating system.

The advantage of the system is that it keeps the inventory at an optimum level, thus reducing waste. The disadvantages of these systems are the initial purchase cost and an ongoing expense because each container in the machine has to be calibrated to the drug and to the particular brand.

口服固体药品重新包装成单剂量后,如何豁免稳定性研究和指定有效期?

The determination may be made by direct measurement at the place or may be based on reported climatic conditions. Determination is based on not less than 12 equally spaced measurements that encompass either a season, a year, or, where recorded data demonstrate, the storage period of the article. Storage in a container validated to protect the article from moisture vapor, including storage in bulk, is considered a dry place.

Articles shall be protected from moisture, freezing, and excessive heat, and, where necessary, from light during shipping and distribution. Active pharmaceutical ingredients are exempt from this requirement. A shipping container containing a single article, unless such container is also essentially the immediate container or the outside of the consumer package, is labeled with a minimum of product identification except for controlled articles , lot number, expiration date, and conditions for storage and distribution.

In May , a Notice of Availability of the draft revision of FDA’s Compliance Policy Guide Section (CPG b), “Expiration Dating of Unit-Dose Repackaged Drugs,” was announced in the Federal Register.

Processes in the manufacturing of solid-dosage forms have stayed relatively the same for years. Innovations such as continuous manufacturing, however, have been making strides. The ETT has been working with companies on continuous manufacturing processes such as continuous aseptic spray drying and model-based control strategy.

It has also been part of the development of ultra-long-acting oral formulations. One novel approach that entered the market a couple of years ago was 3-D printing of solid-dosage drugs. But has FDA seen more from manufacturers on 3D printing, continuous manufacturing, or other technologies?

FDA Eases Expiration Date Requirements for Repackaged Solid Oral Dosage Drugs

This amended authorization letter responds to that request. Your submissions also refer to an individual Household Antibiotic Kit iHAK , which would be stored at an eligible USPS participant’s workplace and would contain only one unit-of-use bottle of doxycycline hyclate tablets mg and emergency use instructions. Leavitt, Determination Pursuant to Sec. The indication includes presumed exposure, since it is often difficult to know whether and when exposure has actually occurred.

The Auto-Print SUPERCEL® side of the unit-dose package allows for clear visibility of the packaged medication, and six different colors of film are available to allow for identification of controlled medications or for use in color coding medications by expiration dates.

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.

Human Drug cGMP Notes – (Volume 8, Number 2)

Descriptions of testing procedures for raw materials and finished products. Any other information that may be indicative of the quality of a given finished drug product. There should be no history of recurring product recalls indicative of deficient quality control procedures. The supplier should permit visits during normal business hours by the pharmacist to inspect its manufacturing and control procedures.

To the extent possible, all products should be available in single unit or unit dose packages. The name and address of the manufacturer of the final dosage form and the packager or distributor should be present on the product labeling.

Extemporaneous Unit-Dose Packaging of Oral Solids number, and expiration date of the article. Unit-Dose Container: A unit-dose beyond-use dating of repackaged unit-dose containers: (USP 30). The beyond-use date is the date after which an article must not be used. The.

This general chapter contains minimum standards to be used as a guideline for repackaging practices. This guideline is not intended to replace or supplant the requirements of regulatory agencies. Repackaging preparations into unit-dose configurations is an important aspect of pharmaceutical care and of optimization of patient compliance.

For purposes of this chapter, there are two types of repackaging: In addition, dispensers may prepare limited quantities in anticipation of a prescription or medication order from a physician. Dispensers are governed by the board of pharmacy of the individual state. The terms dispenser and pharmacy are used interchangeably. Repackaging firms repackage preparations for distribution e.

Distribution is not patient specific in that there are no prescriptions.

USFDA Guidelines for Pharmaceuticals

For A and B compounding pharmacies, how do you protect your business from heavy-handed interventions from State and Federal Regulators? Can you affirmatively respond to the following questions? Do you know the Federal and State laws you are required to follow? Do you have the right enabling documentation procedures, policies, records, etc. Are you organized effectively to execute the requirements?

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An official dosage form is required to bear on its label an expiration date assigned for the particular formulation and package of the article. This date limits the time during which the product may be dispensed or used. However, under no circumstance should the repackaged pharmaceutical preparation’s expiration date exceed the original manufacturer’s expiration date. It is necessary, therefore, that other precautions be taken by the dispenser to preserve the strength, quality, and purity of drugs that are repackaged for ultimate distribution or sale to patients.

The following guidelines and requirements are applicable where official dosage forms are repackaged into single-unit or unit-dose containers or mnemonic packs for dispensing pursuant to prescription. Repackaged dosage forms must bear on their labels expiration dates as determined from information in the product labeling see Preservation, Packaging, Storage, and Labeling section of the General Notices and Requirements. Each single-unit or unit-dose container bears a separate label, unless the device holding the unit-dose form does not allow for the removal or separation of the intact single-unit or unit-dose container therefrom.

A refrigerator or freezer shall not be considered to be a humidity-controlled environment. Drugs that are to be stored at a cold temperature in a refrigerator or freezer must be protected during storage in the refrigerator or freezer. An outer container may be necessary for such protection; it is recommended that the drug monograph be referenced for storage.

News about GMP/cGMP

This chapter does not apply to pharmacists engaged in dispensing prescription drugs in accordance with state practice of pharmacy. The pharmacist needs to apply and other beyond-use date references in the subsection Expiration Date and Beyond-Use Date in the Labeling section under General Notices and Requirements. Repackaging firms repackage preparations for distribution e. Distribution is not patient-specific in that there are no prescriptions.

On Jan. 22, , FDA’s Center for Drug Evaluation and Research (CDER) announced their agenda for new and revised draft guidance documents the center plans on publishing in Of the approximately draft guidance documents the center plans on publishing in , the majority address clinical, quality, and procedural issues.

Nice Pacer, Mean Pacer: Hal and Carly arrived with Qdoba in hand and smiles on their faces after a long drive down from Ashland. After a glass of wine and plenty of catching up, we all hit the hay to get in a very important night of sleep. JB forgot to grab his running shorts and instead put on mine for his run- making us all laugh and forget the nerves for a little while.

Jen and Carly post run About Carly and I hit Starbucks to get a much needed shot of caffiene while the guys headed over to get in line for the medical check and schwag bag pick up.

CPSC Staff Webinar on Testing and Certification Requirements for Special Packaging


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