BACKGROUND.A. The Practice of Repackaging, in General The Food and Drug Administration (FDA) defines repackaging as the process of moving a finished drug product from the container in which it was distributed by the original manufacturer to a different container without making any other changes to the drug. Repackaging is considered to be an acceptable practice.
What does mislabeled mean in pharmacy?
April 11, 2016 Customers can get information about the drug they are taking thanks to the prescription labels. The name of the medication, the appropriate dosage, and the directions should all be included on the label. Along with the container for the pills, a brochure containing information on the possible adverse reactions to the medication is often included inside the bag.
- Before leaving the pharmacy, it is essential for a person to have all of this information in order to guarantee that the medicine will be taken appropriately, and it is the role of a pharmacist to ensure that a patient has the necessary information.
- On the other hand, there are situations in which a careless pharmacist or pharmacy technician may incorrectly label a container of medication.
Errors in labeling can include, but are not limited to: Insufficient instructions or enough cautions are not provided. A patient is responsible for being aware of any and all special requirements that their medicine may have, including whether it must be taken with meals, how long they must avoid the sun, or any other necessity.
- When pharmaceutical instructions, like these, are not provided, a person taking the medicine may take it wrongly and may not comprehend the potentially hazardous side effects that may arise.
- Directions that are incorrect.
- Sometimes, when typing the instructions on the prescription bottle label, pharmacists make a typing error.
For example, the doctor may have written a prescription for a drug that should be taken three times a week, but the pharmacist may have accidentally typed the directions so that they should be read three times a day. It’s also possible that the doctor prescribed 10 milligrams to be taken once every seven days rather than once every day, or vice versa.
- When directives are given incorrectly, there is a chance that catastrophic repercussions will ensue.
- Incorrect dosage.
- In the event that a patient is picking up two medications from a pharmacy, there is a possibility that the pharmacy may have switched the two medications without the patient’s knowledge by filling the correct medications but placing them in the wrong bottles or applying the wrong labels to the bottles.
As a direct consequence of this, a patient may end up taking the incorrect dosage of the correct prescription, which may result in either an overdose or an underdose. If a pharmacist gives the wrong instructions or inadequate information, a customer may wind up taking more than twice the dose that was given to them or less than the dose that they were supposed to take.
- In either scenario, the patient may suffer significant consequences as a result of the incorrect categorization.
- In the event that an error at the pharmacy caused you to sustain unneeded injuries and rack up unwarranted medical expenditures, you should speak with a seasoned attorney about your legal options as soon as possible.
We would be delighted to take your call and would be happy to give you with a no-cost consultation.
Why are medications sometimes repackaged?
Because the original producer of many drugs does not package them in unit dosages or because they are made and packed in bulk, there has been a rise in the need for repackaging pharmaceuticals. Repackaging prescription medicine items helps to cut down on medication mistakes, which in turn boosts both the patients’ and the drug’s overall levels of safety and effectiveness.
What is compounding and repackaging?
‘The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery. device, or device in accordance with a licensed. practitioner’s prescription, medication order, or. initiative based on the.
What does repackaged label mean?
Medication that has been repackaged has merely had its previous packaging removed and been replaced with a new style of packaging that is more convenient, less hazardous, and more compact.
What means mislabeled?
Mis·la·bel | \ ˌmis-ˈlā-bəl \ mislabeled or mislabelled; mislabelling or mislabelling transitive verb: to improperly or falsely label (something). According to the results of DNA testing conducted on seafood in Texas and other locations, nearly one-third of the time, seafood that is sold in markets and restaurants is mislabeled. — Bill Lambrecht
What is a mislabeled specimen?
For instance, if a specimen from one patient is mistakenly labeled with the name of another patient, some research refer to this error as “mislabeled specimens,” whereas other studies categorize this error as “wrong blood in tube.”
When medication is repackaged a record is kept for?
Documentation together with labeling – In the event of a crisis, the mark should include proper names, doses, directions, and who should be contacted. In addition to that, the details about the producer have to be mentioned. The physician will add supplementary material, which may include your contact information, the anticipated date of delivery, and any other relevant consumer warnings.
- Maintaining accurate records is a crucial task.
- The firm that is responsible for the repackaging is required to keep quality records for a period of at least one year following the date of the repackaging.
- Documents need to include the number of days since the last repackaging, the name of the prescription, the name of the drug supplier, and the name of the medication.
It is imperative that both the dosage and the potency of the drug be specified. A person in a position of responsibility inside the repackaging firm is required to examine and sign off on these measures.
Is repackaging considered manufacturing?
| Questions and Answers | Keyword(s) | Category | (hidden – contains search text) | (hidden – contains search text) | FedFac |
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| 168. Are on-site warehouses subject to the threshold determinations of section 313? Warehouse operations can require threshold determinations. Reporting thresholds are based on “manufacture,” “process,” or “otherwise use” of an EPCRA section 313 chemical at the facility. Repackaging (e.g. , pouring the contents of a 55 gallon drum into smaller containers) for distribution into commerce (e.g. , shipped off-site to another federal facility within the same agency) at a warehouse is considered processing and the repackaged quantities of the EPCRA section 313 chemicals must be counted in the facility’s “process” threshold determinations. Simply receiving, storing, relabeling, distributing, or reshipping pre-packaged quantities from a shipment of packages is not “manufacture,” “process,” or “otherwise use. ” | Facility; Manufacture; Otherwise Use; Process; Repackage; Threshold Determination; Warehouse | 1. Determining Whether or Not to Report: Facility > 1.E. Threshold Determinations | 19168 19-168 168 2019 Questions and Answers Consolidation1. Determining Whether or Not to Report: Facility 1.E. Threshold Determinations Facility; Manufacture (Manufactured; Manufacturing; Produce; Produced); Otherwise Use; Process (Processing; Processed; Processes); Repackage (Repackaging); Threshold Determination (Activity Threshold); Warehouse 168. Are on-site warehouses subject to the threshold determinations of section 313?Warehouse operations can require threshold determinations. Reporting thresholds are based on “manufacture,” “process,” or “otherwise use” of an EPCRA section 313 chemical at the facility. Repackaging (e.g. , pouring the contents of a 55 gallon drum into smaller containers) for distribution into commerce (e.g. , shipped off-site to another federal facility within the same agency) at a warehouse is considered processing and the repackaged quantities of the EPCRA section 313 chemicals must be counted in the facility’s “process” threshold determinations. Simply receiving, storing, relabeling, distributing, or reshipping pre-packaged quantities from a shipment of packages is not “manufacture,” “process,” or “otherwise use. ” | Y | |
| 217. Does it matter for purposes of determining the processing threshold if amounts that are received in smaller containers are removed from the smaller containers and repackaged into a larger container prior to their distribution in commerce? No. The act of transferring any amount from one unit container to another prior to distributing the material in commerce constitutes the act of processing. The size of the container does not matter. | Process; Repackage | 1. Determining Whether or Not to Report: Facility > 1.F. Manufacturing Processing or Otherwise Use | 19217 19-217 217 2019 Questions and Answers Consolidation1. Determining Whether or Not to Report: Facility 1.F. Manufacturing Processing or Otherwise Use Process (Processing; Processed; Processes); Repackage (Repackaging) 217. Does it matter for purposes of determining the processing threshold if amounts that are received in smaller containers are removed from the smaller containers and repackaged into a larger container prior to their distribution in commerce?No. The act of transferring any amount from one unit container to another prior to distributing the material in commerce constitutes the act of processing. The size of the container does not matter. | – | |
| 218. Does breaking the integrity of the package that contains the toxic chemical constitute repackaging? No. The listed toxic chemical must be transferred from one package to another in order for the listed toxic chemical to be considered repackaged. | Repackage | 1. Determining Whether or Not to Report: Facility > 1.F. Manufacturing Processing or Otherwise Use | 19218 19-218 218 2019 Questions and Answers Consolidation1. Determining Whether or Not to Report: Facility 1.F. Manufacturing Processing or Otherwise Use Repackage (Repackaging) 218. Does breaking the integrity of the package that contains the toxic chemical constitute repackaging?No. The listed toxic chemical must be transferred from one package to another in order for the listed toxic chemical to be considered repackaged. | – | |
| 219. A covered facility receives shipments of an EPCRA section 313 listed toxic chemical in rail cars. The listed toxic chemical is transferred from the rail cars into large tank trucks for distribution to customers. The quantity of the listed toxic chemical held in the tank trucks is approximately equivalent to the amount held in the rail cars. Would the transfer of the listed toxic chemical from the rail cars to the tank trucks be considered repackaging and therefore included in processing threshold determinations? Yes. All activities involving the preparation of a listed toxic chemical, after its manufacture, for distribution in commerce are to be included in the processing threshold determination for that chemical. The Agency defines processing to include ‘. . the preparation of a chemical for distribution in commerce in a desirable form, state, and/or quantity (i.e. , repackaging). . ‘ (53 FR 4506; February 16, 1988). The act of removing a listed toxic chemical from one container and placing it in another is considered repackaging, regardless of the size of the containers involved. As such, the facility must include any amounts of a listed toxic chemical transferred from the rail cars to the tank trucks in its processing threshold for that chemical. | Process; Repackage | 1. Determining Whether or Not to Report: Facility > 1.F. Manufacturing Processing or Otherwise Use | 19219 19-219 219 2019 Questions and Answers Consolidation1. Determining Whether or Not to Report: Facility 1.F. Manufacturing Processing or Otherwise Use Process (Processing; Processed; Processes); Repackage (Repackaging) 219. A covered facility receives shipments of an EPCRA section 313 listed toxic chemical in rail cars. The listed toxic chemical is transferred from the rail cars into large tank trucks for distribution to customers. The quantity of the listed toxic chemical held in the tank trucks is approximately equivalent to the amount held in the rail cars. Would the transfer of the listed toxic chemical from the rail cars to the tank trucks be considered repackaging and therefore included in processing threshold determinations?Yes. All activities involving the preparation of a listed toxic chemical, after its manufacture, for distribution in commerce are to be included in the processing threshold determination for that chemical. The Agency defines processing to include ‘. . the preparation of a chemical for distribution in commerce in a desirable form, state, and/or quantity (i.e. , repackaging). . ‘ (53 FR 4506; February 16, 1988). The act of removing a listed toxic chemical from one container and placing it in another is considered repackaging, regardless of the size of the containers involved. As such, the facility must include any amounts of a listed toxic chemical transferred from the rail cars to the tank trucks in its processing threshold for that chemical. | – | |
| 220. Lab packs and hazardous waste in general tend to move progressively from smaller containers to larger containers. Is this repackaging activity covered by the processing threshold? Repackaging toxic chemicals in hazardous waste may be covered by the processing threshold. For an activity to be considered processing under EPCRA section 313, the toxic chemical must be prepared for distribution in commerce. If the listed toxic chemical is not removed or taken from the smallest unit, but is simply placed in a larger container while the contents remain in the smaller container, then the listed toxic chemical is not considered to be repackaged. If the listed toxic chemical is taken out of the smallest unit container and is transferred to another container, it is considered repackaged. However, if, after the toxic chemical has been repackaged, it is not distributed in commerce (e.g. , instead of being distributed in commerce, it is sent off-site for disposal or treatment) the activity is not a covered processing activity under EPCRA section 313. It would only be considered processed if the toxic chemicals in the lab packs, after being repackaged, are sent off-site for recycling or for further use or reuse. | Hazardous Waste; Process; Repackage | 1. Determining Whether or Not to Report: Facility > 1.F. Manufacturing Processing or Otherwise Use | 19220 19-220 220 2019 Questions and Answers Consolidation1. Determining Whether or Not to Report: Facility 1.F. Manufacturing Processing or Otherwise Use Hazardous Waste; Process (Processing; Processed; Processes); Repackage (Repackaging) 220. Lab packs and hazardous waste in general tend to move progressively from smaller containers to larger containers. Is this repackaging activity covered by the processing threshold?Repackaging toxic chemicals in hazardous waste may be covered by the processing threshold. For an activity to be considered processing under EPCRA section 313, the toxic chemical must be prepared for distribution in commerce. If the listed toxic chemical is not removed or taken from the smallest unit, but is simply placed in a larger container while the contents remain in the smaller container, then the listed toxic chemical is not considered to be repackaged. If the listed toxic chemical is taken out of the smallest unit container and is transferred to another container, it is considered repackaged. However, if, after the toxic chemical has been repackaged, it is not distributed in commerce (e.g. , instead of being distributed in commerce, it is sent off-site for disposal or treatment) the activity is not a covered processing activity under EPCRA section 313. It would only be considered processed if the toxic chemicals in the lab packs, after being repackaged, are sent off-site for recycling or for further use or reuse. | – | |
| 221. Does the placing of a bulk liquid containing a small percentage of a Section 313 toxic chemical into small bottles for consumer sale constitute a reportable/threshold activity of the mixture? Yes, repackaging for distribution in commerce is a type of processing (40 CFR Section 372.3). If the bulk liquid contains a Section 313 listed non-PBT chemical in excess of the de minimis level or a listed PBT chemical at any concentration, the toxic chemical in the liquid would have to be factored into calculations in determining whether the processing threshold is exceeded for that toxic chemical. | Activity Threshold; Process; Repackage | 1. Determining Whether or Not to Report: Facility > 1.F. Manufacturing Processing or Otherwise Use | 19221 19-221 221 2019 Questions and Answers Consolidation1. Determining Whether or Not to Report: Facility 1.F. Manufacturing Processing or Otherwise Use Activity Threshold (Threshold Determination); Process (Processing; Processed; Processes); Repackage (Repackaging) 221. Does the placing of a bulk liquid containing a small percentage of a Section 313 toxic chemical into small bottles for consumer sale constitute a reportable/threshold activity of the mixture?Yes, repackaging for distribution in commerce is a type of processing (40 CFR Section 372.3). If the bulk liquid contains a Section 313 listed non-PBT chemical in excess of the de minimis level or a listed PBT chemical at any concentration, the toxic chemical in the liquid would have to be factored into calculations in determining whether the processing threshold is exceeded for that toxic chemical. | – | |
| 222. A multi-establishment facility, with a primary NAICS code 324 operates a petroleum bulk plant, with NAICS code 424710. The bulk plant receives gasoline from tanker trucks and stores the gasoline in storage tanks on-site. The facility also loads other tanker trucks with gasoline that distribute the gasoline to service stations. Are the listed toxic chemicals in the gasoline processed, otherwise used, or neither? Since the facility repackages the gasoline by transferring it between trucks and bulk storage containers for further distribution into commerce, the facility is processing the listed toxic chemicals in the gasoline. | Activity Threshold; Process; Repackage | 1. Determining Whether or Not to Report: Facility > 1.F. Manufacturing Processing or Otherwise Use | 19222 19-222 222 2019 Questions and Answers Consolidation1. Determining Whether or Not to Report: Facility 1.F. Manufacturing Processing or Otherwise Use Activity Threshold (Threshold Determination); Process (Processing; Processed; Processes); Repackage (Repackaging) 222. A multi-establishment facility, with a primary NAICS code 324 operates a petroleum bulk plant, with NAICS code 424710. The bulk plant receives gasoline from tanker trucks and stores the gasoline in storage tanks on-site. The facility also loads other tanker trucks with gasoline that distribute the gasoline to service stations. Are the listed toxic chemicals in the gasoline processed, otherwise used, or neither?Since the facility repackages the gasoline by transferring it between trucks and bulk storage containers for further distribution into commerce, the facility is processing the listed toxic chemicals in the gasoline. | – | |
| 224. A petroleum bulk plant receives petroleum via pipeline. The petroleum goes from the pipe into a storage tank and exits the facility again through the pipeline. It is then sent to another petroleum bulk plant within the same company but located on non-contiguous and non-adjacent property, which distributes the petroleum into commerce (i.e. , their customers). Did the first plant repackage and therefore process the petroleum? Yes. The petroleum received via pipeline, stored and subsequently transferred to another facility has been repackaged and the listed toxic chemicals have been distributed in commerce. Amounts of listed toxic chemicals contained in the amount repackaged must be considered toward the processing threshold. | Process; Repackage | 1. Determining Whether or Not to Report: Facility > 1.F. Manufacturing Processing or Otherwise Use | 19224 19-224 224 2019 Questions and Answers Consolidation1. Determining Whether or Not to Report: Facility 1.F. Manufacturing Processing or Otherwise Use Process (Processing; Processed; Processes); Repackage (Repackaging) 224. A petroleum bulk plant receives petroleum via pipeline. The petroleum goes from the pipe into a storage tank and exits the facility again through the pipeline. It is then sent to another petroleum bulk plant within the same company but located on non-contiguous and non-adjacent property, which distributes the petroleum into commerce (i.e. , their customers). Did the first plant repackage and therefore process the petroleum?Yes. The petroleum received via pipeline, stored and subsequently transferred to another facility has been repackaged and the listed toxic chemicals have been distributed in commerce. Amounts of listed toxic chemicals contained in the amount repackaged must be considered toward the processing threshold. | – | |
| 226. A covered facility receives a chemical in bulk, repackages the chemical into reusable containers that are sent to customers, who then return the containers to be refilled. How does the facility consider residual amounts of the product returned to the facility in used containers, which are then subsequently refilled and redistributed in commerce? When the facility originally places the toxic chemical into the reusable containers, the facility is processing toxic chemicals. Because the residual amounts that are returned to the facility in the reusable containers are not transferred to other containers or packages, the residual amounts have not been repackaged. Therefore, the listed chemicals in the residual amounts do not have to be considered toward the facility’s processing threshold again. | Process; Repackage | 1. Determining Whether or Not to Report: Facility > 1.F. Manufacturing Processing or Otherwise Use | 19226 19-226 226 2019 Questions and Answers Consolidation1. Determining Whether or Not to Report: Facility 1.F. Manufacturing Processing or Otherwise Use Process (Processing; Processed; Processes); Repackage (Repackaging) 226. A covered facility receives a chemical in bulk, repackages the chemical into reusable containers that are sent to customers, who then return the containers to be refilled. How does the facility consider residual amounts of the product returned to the facility in used containers, which are then subsequently refilled and redistributed in commerce?When the facility originally places the toxic chemical into the reusable containers, the facility is processing toxic chemicals. Because the residual amounts that are returned to the facility in the reusable containers are not transferred to other containers or packages, the residual amounts have not been repackaged. Therefore, the listed chemicals in the residual amounts do not have to be considered toward the facility’s processing threshold again. | – | |
| 227. A covered facility receives a chemical in bulk and repackages it into smaller containers that are sent to consumers. Are amounts repackaged considered toward an activity threshold? Amounts of the toxic chemical that a covered facility repackages for distribution in commerce must be considered toward the processing threshold. | Process; Repackage | 1. Determining Whether or Not to Report: Facility > 1.F. Manufacturing Processing or Otherwise Use | 19227 19-227 227 2019 Questions and Answers Consolidation1. Determining Whether or Not to Report: Facility 1.F. Manufacturing Processing or Otherwise Use Process (Processing; Processed; Processes); Repackage (Repackaging) 227. A covered facility receives a chemical in bulk and repackages it into smaller containers that are sent to consumers. Are amounts repackaged considered toward an activity threshold?Amounts of the toxic chemical that a covered facility repackages for distribution in commerce must be considered toward the processing threshold. | – | |
| 228. After an EPCRA section 313 toxic chemical is spent, a covered facility removes waste containing the toxic chemical from the production process and places it into drums. The facility sends these drums containing 30,000 pounds of the toxic chemical off-site to be recycled. The facility exceeds the 25,000-pound processing threshold for this toxic chemical and is required to file a Form R for the listed toxic chemical. What is the appropriate box to check in Part I, Section 3.2 of the Form R? All activities involving the preparation of a listed toxic chemical, after its manufacture, for distribution in commerce are to be included in the processing threshold determination for that chemical. The act of repackaging an EPCRA section 313 toxic chemical and then transferring it off-site for recycling is considered processing. As such, facilities sending toxic chemicals in wastes off-site for recycling should check ‘repackaging’ in Part I, Section 3.2 of the Form R. | Recycling; Repackage | 1. Determining Whether or Not to Report: Facility > 1.F. Manufacturing Processing or Otherwise Use | 19228 19-228 228 2019 Questions and Answers Consolidation1. Determining Whether or Not to Report: Facility 1.F. Manufacturing Processing or Otherwise Use Recycling (Recycle); Repackage (Repackaging) 228. After an EPCRA section 313 toxic chemical is spent, a covered facility removes waste containing the toxic chemical from the production process and places it into drums. The facility sends these drums containing 30,000 pounds of the toxic chemical off-site to be recycled. The facility exceeds the 25,000-pound processing threshold for this toxic chemical and is required to file a Form R for the listed toxic chemical. What is the appropriate box to check in Part I, Section 3.2 of the Form R?All activities involving the preparation of a listed toxic chemical, after its manufacture, for distribution in commerce are to be included in the processing threshold determination for that chemical. The act of repackaging an EPCRA section 313 toxic chemical and then transferring it off-site for recycling is considered processing. As such, facilities sending toxic chemicals in wastes off-site for recycling should check ‘repackaging’ in Part I, Section 3.2 of the Form R. | – | |
| 230. A covered facility receives a shipment of five-gallon cans of paint containing a listed toxic chemical. The facility breaks up the shipment into separate five-gallon cans and packages each can in a box with a paint brush for sale. Is the listed toxic chemical repackaged and thus processed for purposes of EPCRA section 313? No. ‘Repackaging’ refers to the act of removing a toxic chemical from one container and placing that toxic chemical into another container. Simply repackaging one container (that contains a toxic chemical) into another container does not constitute processing of that listed toxic chemical under EPCRA section 313. The nesting of containers is not repackaging for EPCRA section 313 purposes. | Activity Threshold; Process; Repackage | 1. Determining Whether or Not to Report: Facility > 1.F. Manufacturing Processing or Otherwise Use | 19230 19-230 230 2019 Questions and Answers Consolidation1. Determining Whether or Not to Report: Facility 1.F. Manufacturing Processing or Otherwise Use Activity Threshold (Threshold Determination); Process (Processing; Processed; Processes); Repackage (Repackaging) 230. A covered facility receives a shipment of five-gallon cans of paint containing a listed toxic chemical. The facility breaks up the shipment into separate five-gallon cans and packages each can in a box with a paint brush for sale. Is the listed toxic chemical repackaged and thus processed for purposes of EPCRA section 313?No. ‘Repackaging’ refers to the act of removing a toxic chemical from one container and placing that toxic chemical into another container. Simply repackaging one container (that contains a toxic chemical) into another container does not constitute processing of that listed toxic chemical under EPCRA section 313. The nesting of containers is not repackaging for EPCRA section 313 purposes. | – | |
| 231. A facility receives a waste from off-site, samples the waste, and then sends the remaining waste off-site to be recycled without changing the packaging. Has the facility processed the listed toxic chemical in the waste? No. Provided that the listed toxic chemical transferred to the off-site facility remains in the packaging in which it was received, it has not been repackaged. The facility has simply opened the original package for sampling and transferred the listed toxic chemical to another facility. Because no repackaging has occurred, no processing has taken place. | Process; Repackage | 1. Determining Whether or Not to Report: Facility > 1.F. Manufacturing Processing or Otherwise Use | 19231 19-231 231 2019 Questions and Answers Consolidation1. Determining Whether or Not to Report: Facility 1.F. Manufacturing Processing or Otherwise Use Process (Processing; Processed; Processes); Repackage (Repackaging) 231. A facility receives a waste from off-site, samples the waste, and then sends the remaining waste off-site to be recycled without changing the packaging. Has the facility processed the listed toxic chemical in the waste?No. Provided that the listed toxic chemical transferred to the off-site facility remains in the packaging in which it was received, it has not been repackaged. The facility has simply opened the original package for sampling and transferred the listed toxic chemical to another facility. Because no repackaging has occurred, no processing has taken place. | – | |
| 277. A car manufacturer has a central 25,000 gallon storage tank on-site. A pipe leads from the central storage tank to a fill station where the cars are filled with gas before being sent off-site to be sold. Is the processing of the toxic chemical components of the gasoline considered ‘repackaging only’ or ‘as an article component’ in Part II, Section 3.2(e) of the Form R? The toxic chemicals in the gasoline should be reported as processed as an ‘article component’ because they are incorporated into the car which is an article (40 CFR Section 372.3). | Articles Exemption; Process; Repackage; Storage Tanks | 1. Determining Whether or Not to Report: Facility > 1.F. Manufacturing Processing or Otherwise Use | 19277 19-277 277 2019 Questions and Answers Consolidation1. Determining Whether or Not to Report: Facility 1.F. Manufacturing Processing or Otherwise Use Articles Exemption (Article Exemption); Process (Processing; Processed; Processes); Repackage (Repackaging); Storage Tanks 277. A car manufacturer has a central 25,000 gallon storage tank on-site. A pipe leads from the central storage tank to a fill station where the cars are filled with gas before being sent off-site to be sold. Is the processing of the toxic chemical components of the gasoline considered ‘repackaging only’ or ‘as an article component’ in Part II, Section 3.2(e) of the Form R?The toxic chemicals in the gasoline should be reported as processed as an ‘article component’ because they are incorporated into the car which is an article (40 CFR Section 372.3). | – | |
| 846. A covered facility repackages and distributes some toxic chemicals manufactured by other companies. Is the facility responsible only for passing on the manufacturer’s information to its customers or is it required to provide supplier notification? The repackaging facility must provide supplier notification to its customers only if it is in a NAICS code corresponding to SIC codes 20 through 39. If the only information the facility knows is from the SDS, all it can do is provide this same information to its customers. If the facility knows the product contents or concentrations are different from what appears on the supplier’s notice, the facility must provide the more accurate information to its customers. EPA suggests, but does not require, that the repackager inform the supplier of the inaccuracy in their SDS. If the facility is not in a NAICS code corresponding to SIC codes 20 through 39, but instead, is a covered facility in a newly added industry beginning in 1998, it would not be required to initiate supplier notification. It should, however, pass along such notices prepared by their supplier to any facility in a covered NAICS code who purchases a mixture or trade name product containing a toxic chemical. | Repackage; Supplier Notification | 6. Supplier Notification | 19846 19-846 846 2019 Questions and Answers Consolidation6. Supplier Notification 6. Supplier Notification Repackage (Repackaging); Supplier Notification (Supplier Notice) 846. A covered facility repackages and distributes some toxic chemicals manufactured by other companies. Is the facility responsible only for passing on the manufacturer’s information to its customers or is it required to provide supplier notification?The repackaging facility must provide supplier notification to its customers only if it is in a NAICS code corresponding to SIC codes 20 through 39. If the only information the facility knows is from the SDS, all it can do is provide this same information to its customers. If the facility knows the product contents or concentrations are different from what appears on the supplier’s notice, the facility must provide the more accurate information to its customers. EPA suggests, but does not require, that the repackager inform the supplier of the inaccuracy in their SDS. If the facility is not in a NAICS code corresponding to SIC codes 20 through 39, but instead, is a covered facility in a newly added industry beginning in 1998, it would not be required to initiate supplier notification. It should, however, pass along such notices prepared by their supplier to any facility in a covered NAICS code who purchases a mixture or trade name product containing a toxic chemical. | – | |
| 944. A DOD facility has a petroleum bulk terminal for storing fuel that contains EPCRA section 313 chemicals. The fuel is periodically transferred from the petroleum bulk terminal to other parts of the facility. Although this transfer is “repackaging,” the facility does not distribute the fuel in commerce. Must the facility consider the amount of EPCRA section 313 chemicals in the fuel towards its processing threshold? What about the otherwise use threshold? Quantities of EPCRA section 313 chemicals that are “repackaged” but not distributed in commerce do not meet the definition of “processed. ” However, if the fuel is used on-site in a non-exempt activity, the EPCRA section 313 chemicals in the fuel must be considered in the facility’s “otherwise use” threshold determinations. If the facility exceeds the “otherwise use” threshold for any EPCRA section 313 chemicals in the fuel, then the facility must report any releases or other waste management activities for the chemicals, such as any releases that occur during the “repackaging” step. | Fuel; Otherwise Use; Process; Releases; Repackage; Threshold Determination | 1. Determining Whether or Not to Report: Facility > 1.E. Threshold Determinations | 19944 19-944 944 2019 Questions and Answers Consolidation1. Determining Whether or Not to Report: Facility 1.E. Threshold Determinations Fuel; Otherwise Use; Process (Processing; Processed; Processes); Releases (Released); Repackage (Repackaging); Threshold Determination (Activity Threshold) 944. A DOD facility has a petroleum bulk terminal for storing fuel that contains EPCRA section 313 chemicals. The fuel is periodically transferred from the petroleum bulk terminal to other parts of the facility. Although this transfer is “repackaging,” the facility does not distribute the fuel in commerce. Must the facility consider the amount of EPCRA section 313 chemicals in the fuel towards its processing threshold? What about the otherwise use threshold?Quantities of EPCRA section 313 chemicals that are “repackaged” but not distributed in commerce do not meet the definition of “processed. ” However, if the fuel is used on-site in a non-exempt activity, the EPCRA section 313 chemicals in the fuel must be considered in the facility’s “otherwise use” threshold determinations. If the facility exceeds the “otherwise use” threshold for any EPCRA section 313 chemicals in the fuel, then the facility must report any releases or other waste management activities for the chemicals, such as any releases that occur during the “repackaging” step. | Y |
Can nurses repackage medications?
A resident of a nursing facility for whom the medication is to be repackaged is required to sign a “Informed Consent” form that is provided by the facility. This form contains an explanation of the repackaging process and notifies the resident of the immunities from liability provided herein. Only residents who have signed this form will be eligible for repackaging.
What is extemporaneous repackaging?
Repackaging that was done on the spot Repackaging larger quantities of medicines that will be consumed in a relatively short amount of time.
What are the responsibilities of pharmacy technicians who compound and repackage?
What exactly is a Pharmacy Technician? Someone who works in a pharmacy and provides assistance to pharmacists is known as a pharmacy technician. It is the responsibility of a pharmacist to write prescriptions, and pharmacists frequently require assistance with customer service and other administrative chores.
There are a variety of tasks that might fall within the purview of pharmacy technicians, including the gathering of patient information, the labeling of prescriptions, the taking of phone calls, and the invoicing for prescriptions. The specific pharmacy in which they work determines the range and specificity of their employment responsibilities.
Repackaging medication FAQs
Attending pharmacy technician school or a pharmacy technician training program is an option that is frequently pursued by those who are interested in pursuing a career as pharmacy technicians. They will be more prepared for their future career, regardless of whether it is in a compounding pharmacy or a retail pharmacy, thanks to this training.
What is meant by repackage?
The meaning of the term “repackage” a transitive verb meaning to wrap anything up again or for the first time more precisely meaning to put something into a form that is more useful or appealing.
Who can repackage OTC products?
2. The drug product is repackaged at a pharmacy that is licensed by the state, a facility that is operated by the federal government, or an outsourced facility.3. A licensed pharmacist repackages the medication either independently or directly supervising another qualified pharmacist.
Is it mislabeled or mislabelled?
Examples from the Top Quiz on Definitions / msl b l / verb (used with object), mislabeled, mislabelling, or (particularly British) mislabeled, mislabelling; sometimes spelled mislabeled and mislabeled. to label in a manner that is erroneous, inaccurate, or otherwise misleading: to mislabel a bottle of drugs.
- QUIZ THIS QUESTIONNAIRE ON BLUE ANTAGONISTS WILL CERTAINLY “BLUE” YOU AWAY.
- What color would you say is the polar opposite of blue? Test your knowledge of the different ways in which we may define the color that is the antonym of blue.
- In Hindu practice, what does the color SAFFRON represent? The website Dictionary.com Unabridged Random House, Inc.2022 is based on the Random House Unabridged Dictionary.
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What is misbranding of a drug?
Inaccurate or Deceptive Labeling – According to Section 502(a), a medicine or medical device is considered to be misbranded if the labeling associated with it is shown to be inaccurate or deceptive in any way. It is stated in Section 201(n) that in order to determine whether the labeling or advertising of an item is misleading, it is necessary to take into consideration, among other things, not only any representations made or suggested by a statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts that are material in the light of such representations.