Drug expiration dating calculations
Drug expiration dating calculations - catholic girls dating guide
_________________________________________ For questions on patent term, USPTO's Office of Patent Legal Administration help line at 571-272-7702 is available as a resource.
The calculator contains prompts to enter specific information related to the patent in order to help in estimating expiration dates.
In addition, federal and state (NC) regulations require that the following information appear on the label.
"Where possible, the beyond use date should be in accordance with allowances specified in the approved labeling.
One such source is the FDA's Orange Book for Approved Drug Products with Therapeutic Equivalence Evaluations which includes patent expiration dates, some of which may include periods of exclusivity administered by the FDA that add onto patent term.
Additional patent term may also be privately granted by an Act of Congress, and court decisions may establish patent expiration dates that are not reflected in USPTO records.
This means that the product was formulated according to the manufacturer's directions, or that the formulation contains the same concentration of drug, in the same diluent, in the same packaging, for the same intended period of use, and so on. When this is not possible, a pharmacist ideally consults with the manufacturer to establish a beyond use date.
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.
The pharmacist should communicate the deviations from the package insert to the manufacturer when requesting stability information.
Otherwise, the pharmacist should ensure that the manufacturer's stability information is product specific, that is, the exact strength, diluent, fill volume, and container type (PVC bag, plastic syringe, elastomeric infusion device, etc.) will be used by the pharmacist when preparing the HSD.
The factors include the following: The term of a patent is important in that it provides the specified period for infringement.
In general, for the term of a patent, whoever without authority makes, uses, offers to sell or sells the patented invention, within the United States, or imports into the United States any patented invention during the term is an infringer of the patent and may be subject to monetary damages, injunction and other forms of legal relief.
It is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by a party against the United States, its departments, agencies, instrumentalities, entities, officers, employees or agents, or any other person.