Relates to State Board of Pharmacy, relates to sterile compounding, relates to permits. The bill contains the following provisions. The bill provides a definition for “compounding pharmacy” and describes sterile compounding pharmacies and non sterile compounding pharmacies. Beginning with appointments made on or after January 1, , the bill adds a physician and an advanced practice registered nurse to the Maine Board of Pharmacy, decreases the number of pharmacist members from 5 to 3. MN H Pharmacy Regulation Pending – Carryover Changes licensing requirements for pharmacies, drug manufacturers, and wholesale drug distributors, requires all licensed pharmacies to comply with federal laws and state laws and rules related to operation of a pharmacy, requires out-of-state pharmacies dispensing drugs to residents of Minnesota to comply with federal laws related to operation of a pharmacy. MN H Health Pending – Carryover Relates to health, changes licensing requirements for businesses regulated by the Board of Pharmacy, clarifies requirements for compounding, makes changes to the prescription monitoring program.
In addition, the label on the final container for each biologic states the following: The package label includes all of the above, with the addition of the following: Precautions should be taken where products labeled to be stored at a temperature between 2 and 8 are stored in a refrigerator, in order to assure that they will not be frozen.
Diluents packaged with biologics should not be frozen.
The USP/NF Section. > Sterile Drug Products for Home Use, Storage and Beyond Use Dating directs that: Most pharmacies have the name, address, and phone number of the pharmacy pre-printed on their prescription labels.
Are we required to show them these files? An FDA employee may request under the requirements of the regulations, management with executive responsibility certify in writing that management reviews and quality audits have been performed and documented, the dates on which they were performed, and that “any required corrective action has been undertaken.
While periodic preventative maintenance is always a good business practice, there is no regulatory requirement that the analyzer must be returned to the factory for recertification as long as the analyzer is performing properly. Who can we legitimately sell medical gas products too? Medical Gas Products are prescription legend drug products and can only be sold to the following entities: FDA has agreed to exercise enforcement discretion regarding the sale of Nitrogen NF to firms that install hospital medical gas systems.
NFPA 99 specifically requires the use of Nitrogen NF in purging and pressure testing of healthcare medical gas piping systems. NFPA 99 is the national standard for health care facility medical gas piping systems, and FDA participated directly in the development of elements of the code. While the practice seems to be acceptable in the FDA’s eyes at this time, it is recommended that if you are going to sell to this market, you obtain a letter from the plumbing company stating that “They understand they are obtaining a drug product and will only use it for the intended purpose of purging and pressure testing of healthcare medical gas piping systems.
They are constructing “safe rooms” that are designed to be used in case of events like the one in West Virginia when the miners were trapped underground. It will be used to support life, however it will not be dispensed or provided by an emergency responder or licensed healthcare provider. The oxygen used in these mine refuge chambers would be considere “oxygen for environmental use” which FDA defines as “oxygen that meets USP specifications and is used to support life artificially in environments that are normally deficient.
While the practice seems to be acceptable in the FDA’s eyes at this time, it is recommended that if you are going to sell to this market, you obtain a letter from the owner of the mine refuge chamber stating that “They understand they are obtaining a drug product and attesting that the use of the Medical Oxygen and Breathing Air would be restricted to use in their chamber. Is this a new requirement?
Comment Period Extended for USP Packaging General Chapters Appearing in PF 43(3)
Terminology To get started in this article, there are some terms that should be defined. Prescriptions and over-the-counter medicines and other healthcare products sold in the United States are required to follow the standards in the USP-NF. The USP also sets standards for food ingredients and dietary supplements. Chapters in the USP that are listed as below are considered enforceable, while chapters enumerated as or greater are considered guidelines.
USP Chapter defines Beyond Use Date (BUD) as the date after which a compounded nonsterile preparation (CNSP) should not be used. The BUD is no longer than 6 months or the earliest expiration date of any ingredient used, whichever is shorter, and stored at controlled room temperatures.
The container used depends on the physical and chemical properties of the compounded preparation. Sterility Assurance of sterility in a compounded sterile preparation is mandatory. Stability Criteria and Beyond-Use Dating The beyond-use date is the date after which a compounded preparation is not to be used and is determined from the date the preparation is compounded. Because compounded preparations are intended for administration immediately or following short-term storage, their beyond-use dates may be assigned based on criteria different from those applied to assigning expiration dates to manufactured drug products.
Compounders are to consult and apply drug-specific and general stability documentation and literature when available, and are to consider the nature of the drug and its degradation mechanism, the container in which it is packaged, the expected storage conditions, and the intended duration of therapy when assigning a beyond-use date see Expiration Date and Beyond-Use Date under Labeling in the General Notices and Requirements. Beyond-use dates are to be assigned conservatively.
When using manufactured solid dosage forms to prepare a solution or aqueous suspension, the compounder is also to consider factors such as hydrolysis and the freeze-thaw property of the final preparation before assigning a beyond-use date.
Usp Nf Expiration dating
The critical characteristics of each lot of specimen selected for the standard are usually determined independently in three or more laboratories. In addition, laboratories throughout the nation, both academic and industrial, participate in the testing. Reference Standards are specifically required in many Pharmacopeial assays and tests and are provided solely for such use; suitability for other nonofficial application s rests with the purchaser.
HOSPITAL EXPIRATION DATING PREPACKAGE versus REPACKAGE “Beyond Use” (Expiration Dates) Reference: USP Revised Standards for Product Dating, First Supplement to USP24th rev + NF 19th ed Differentiation between “expiration date” and “beyond use date”.
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. Expiration dates should be clearly indicated on the package label and, unless stability properties warrant otherwise, should occur in January or July.
Are you looking in all the wrong places? When looking for a repackaging distributor, some healthcare providers make choices based solely on the fact that the repackaging company was well known. Then they discover the well-recognized repackaging contractor fell way short on service. In the end, it comes down to solid decision making on your part. Consider these important issues when choosing a repackaging company: Can this company distribute the product where you need it on time and on budget?
USP Chapter : Container Closure Integrity Testing
How often should volumetric solutions be re-standardized? This decision is made based on the stability of the solution, its intended use and storage conditions. If this information is not stated in the text in a USP monograph for the particular volumetric solution, then it is up to your lab to define this frequency. You need to have experimental data to support your decision. Do not assume arbitrary frequencies.
The USP Subcommittee on Packaging, Storage, and Distribution (SCPSD) has revised product dating specifications as they relate to pharmacy practice. As seen in Appendix A, USP defines the.
You will agree with me that an important goal of education is to help students learn how to think. Education for problem solving will help students to think more productively by helping them to combine creative thinking skills to generate ideas and critical thinking skills to evaluate ideas. Being able to apply both thinking skills are necessary for becoming a well-rounded and productive thinker. These are the kind of minds we desperately need in Nigeria and in Africa as a whole. Nigeria is a country replete with problems begging to be solved.
Africa is a continent largely underdeveloped and bogged down by problems left unattended. These problems have over time deteriorated into monstrosities that we are too afraid to even think about ways to tackle them. But the truth remains that these problems exist and must be solved if we are to make life better in our country and continent.
My thinking is, we should tailor our educational system such that learners are equipped and empowered to solve problems, our problems; problems we are facing now and the ones we may not even know we need to solve because we are blinded by the humongous ones we have known and lived with for so many years.
USP Chapter : Container Closure Integrity Testing
Note that this requires knowing what the true value is. Adjuvant A material that enhances the action of a drug or antigen Alcohol Unless otherwise specified, ethyl alcohol ethanol. Concentration is normally in percent by volume. Analyte The specific substance to be determined in an assay or analysis Assay, Analysis Properly, an ‘assay’ determines how much of some particular material is in the sample such as an assay for the Aspirin contentof Aspirin tablets.
facturer specifications or USP standards. lected and inspected for cleanliness and correct func- 3. Bulk component containers are labeled with appro- tioning and is properly used.
Oxygen, while frequently encountered in Pharmaceutical Manufacturing, is not an excipient; but rather because of its reactivity, is some sort of oxidizing reagent. Oxygen has its own USP monograph. It is therefore important to ensure that all steps of the Pharmaceutical Manufacturing process incorporate processes, materials and equipment which minimize any possibility for the introduction of adulterating substances. NF considers Nitrogen and Carbon Dioxide to be an excipient.
These gases have a history of use in other applications. Specifications developed for use in non-pharmaceutical industrial applications may differ from pharmaceutical standards, tests and specifications. Industrial grade gases have none of these cGMP attributes, and may be interpreted by FDA as a potential source of adulterants.
A History: ’s Word of the Year
To mitigate this risk and provide the highest quality preparations to patients, one must fully understand the risk of non-sterility and then identify and carefully interpret available resources on chemical stability. USP defines an expiration date as the date placed by the manufacturer on the container and label of a drug product designating the time frame a product is expected to remain within the approved specifications of its identity, strength, quality, and purity, if stored under the conditions defined on the package insert.
It is important to note that as long as administration of the preparation to the patient began prior to the BUD, the preparation can be used.
August 09, Effective: August 09, until superseded. Subject: Expiration Dating of USP Reference Standards Dear Valued USP Customer, USP Reference Standards do not carry expiration dates in the traditional sense.
Availability and Validity True 7. As per Section 5. This service is not available for the release of back-ordered products or lot changeovers. To receive a monthly list of lot changeovers, please subscribe to our free monthly Email Notice. USP strives to plan ahead to replace depleted lots in a timely manner. However, despite our best efforts, some USP Reference Standards might occasionally be out of stock temporarily.
Contact Reference Standards Technical Service rstech usp. Products that become available within 30 days of your order will be shipped to you automatically. If the product becomes available after 30 days, USP will send you a Notice of Availability to get your confirmation before shipping the order. Are the impurities listed in a table of a specific USP compendial monograph and other required chemicals and reagents available from USP? All USP Reference Standards that are required to carry out the tests within a specific monograph will be provided in a list at the end of a monograph.
If a product is determined by USP to no longer meet the USP compendial requirements, USP will notify customers who purchased the product in the last 12 months that it is being withdrawn. These sources are updated on a daily basis. It is the responsibility of the user to ascertain that a particular lot of a USP Reference Standard has official status either as a “Current Lot” or as a “Previous Lot” within the valid use date.