Beyond use date PDF

PDF | On Dec 1, 2012, Fauna Herawati and others published Beyond Use Date | Find, read and cite all the research you need on ResearchGat (syl) p3040.pdf. Tabel 1. Beyond Use Date Beberapa Produk Vaksin1,3 Nama Vaksin Nama Dagang Pabrik Pembuat BUD yang diizinkan Persyaratan Kondisi Produk Vaksin Vaksin Penyimpanan Hasil Penyiapan Produk Vaksin* Haemophilus ActHIB (Hib) sanofi pasteur 24 jam Kulkas influenzae tipe-b Hiberix (Hib) GlaxoSmithKline 24 jam Kulkas atau suhu kamar. Beyond Use Date (BUD) is very different from expiration date. USP Chapter 797 defines BUD as the date or time after which a compounded sterile preparation (CSP) may not be stored or transported and is calculated from the date or time of compounding. Expiration date is It is critical to use pre-drawn syringes with the earliest discard time first to avoid waste. If pre-drawn syringes are used, consider the following manufacturer-released information supporting stability of vaccine in vials and in pre-drawn syringes. HQS162F_2021-01 The standard of trust Beyond use date in vial or syringe for COVID-19 Vaccine Beyond-Use Dates • The date (or time) beyond which the drug should not be stored • Assigned by the facilities doing compounding - Needs to be consistent • Deviates from the official labeling (package insert) - Considered compounding • Should be based on drug-specific, scientifically valid research studie

beyond use date pada suhu 2-8°C adalah 24 jam expiration date serbuk injeksi seftriakson 1g dalam vial yang belum dibuka adalah 3 (tiga) tahun; sedangkan setelah direkonstitusi (beyond use date) sifat fisika dan kimia stabil selama 24 jam pada suhu 25°C dan selama 4 hari pada suhu 2-8°C. Single use vial seftriakson yang telah direkonstitus shorter of the two timeframes to determine your CSP's beyond-use date. Q: Does USP provide guidance on beyond-use dates? A: Yes, and most people use the USP limits to determine their beyond-use dates. You can, however, exceed USP's recommended beyond-use dates if you have independent sterility testing done, but most people use the USP limits Beyond Use versus Expiration Date Expiration date - scientifically determined Beyond use date - for prescriptions or repackaged drug (the date after which a dispensed product should no longer be used by a patient) Repackaging non-sterile oral and liquid dosage forms packaged in unit -dose container

The expiration date on the label 28 28 Intermediate -acting Insulin (NPH) Humulin N pen The expiration date on the label 14 14 Novolin N pen The expiration date on the label 14 14 Long -acting Insulin Lantus SoloStar The expiration date on the label 28 28 Levmir F lexPen The expiration date on the label 42 4

reduced efficacy. All of these medications should be labeled in such a way that the Beyond Use Date is securely attached to a part of the package and will not be discarded. Beyond use dating can be found in the products package insert under the How Supplied/Storage and Handling section Beyond-Use Date (BUD) (see . General Notices and Requirements . and . Pharmaceutical Compounding — Nonsterile Preparations 〈795〉)—For the purpose of this chapter, the date or time after which a CSP shall not be stored or transported. The date is determined from the date or time the preparation is compounded. Biological Safety Cabinet (BSC

Title: Stability and Sterility: Assigning Beyond Use Dates This activity discusses the factors that influence the stability and sterility of sterile product preparations and considerations when assigning beyond-use dates. Learning Objectives: • List factors that influence beyond-use date assignments for compounded sterile preparations Beyond-Use Date—The beyond-use date is the date after which the prescription drug may not be used. The beyond-use date defines an appropriate period of time during which a prescription drug may be retained by a patient after it is dispensed and takes into account such factors as the conditions under which the medication may b

Use CDC's beyond-use date labels for this vaccine to track storage time at refrigerated temperatures. Expiration Date To determine the expiration date, scan the QR code located on the vial or carton. The QR code will bring up a website; then choose the . lookup option, enter the lot number, and the expiration date will be displayed p3040.pdf. Tabel 1. Beyond Use Date Beberapa Produk Vaksin 1,3 Nama Vaksin Nama Dagang Pabrik Pembuat BUD yang diizinkan Persyaratan Kondisi Produk Vaksin Vaksin Penyimpanan Hasi BEYOND USE DATES: USP Chapter 795 defines Beyond Use Date (BUD) as the date after which a compounded nonsterile preparation (CNSP) should not be used. The BUD is determined from the date the CNSP is compounded. When determining BUD, the pharmacis

The Electromagnetic Spectrum (with Hubble, Webb, and

Expiration Date and Beyond-Use Date section of the chapter. This Revision Bulletin clarifies that the Expiration Date and Beyond-Use Date section of General Chapter <7> that was official prior to May 1, 2019, is still official text in light of the postponement of revisions to this section expiration date. As the expiration date approaches, contact the manufacturer to determine vaccine without ensuring the expiration date has passed. Freezer Before mixing, the vaccine may be stored in the freezer between -25°C and -15°C (-13°F to 5°F) for up to 2 weeks. This beyond-use date replaces the manufacturer's expiration date Compounders provide the beyond-use date (based on the manufacturer's stability information and the literature with respect to stability, compatibility, and degradation of ingredients) to limit patient use of the compounded preparation. All compounded preparations must contain a beyond-use date.10 How do I figure out the beyond-use date for 'beyond use', and for data protection compliance issues to be 'suspended' provided certain safeguards are in place: information has been deleted with no intention on the part of the data controller to use or access this again, but which may still exist in the electronic ether. For example, it could b

(PDF) Beyond Use Date - ResearchGat

ssigning beyond-use dates (BUDs) to compounded sterile prepa-rations (CSPs) is a complex process, fraught with responsibility and risk. 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. administration). Beyond-use exposure and storage dates or times (see Labeling ¢7² and Pharmaceutical Compounding— Nonsterile Preparations ¢795²) for sterile products that have been either opened or prepared for administration are not specified in all package inserts for all sterile products COVID-19 Vaccine Beyond-Use Date(BUD) Summary . For complete storage and handling information, please review each manufactures' EUA Fact Sheet for Providers: Pfizer-BioNTech. Moderna Janssen. Pfizer-BioNTech Moderna Janssen Undiluted Vial Diluted Vial Unpunctured Vial Punctured Vial Unpunctured Vial Punctured Vial Ultra-Cold Freeze Use CDC's freezer storage temperature log for COVID-19 vaccine to document storage unit temperatures. Monitor how long the vaccine has been in the freezer . using CDC's beyond-use date labels for Pfizer-BioNTech . COVID-19 vaccine. » Vaccine stored in the freezer can be transferred to refrigerator storage for an additional 120 hours (5 days) Beyond use dates should be in accordance with the manufacturer's approved labeling. 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

The term, beyond use date, is defined in the 2008 <797> compounding standards as the date or time after which a compounded sterile preparation shall not be stored or transported. 1 The definition proposed in the 2019 revision reads, the date, or the hour and date, beyond which the preparation must not be used and must be discarded. • Prolonged exposure to dexmedetomidine beyond 24 hours may be associated with tolerance and tachyphylaxis and a dose-related increase in adverse events (5.6) -----ADVERSE REACTIONS-----­ • The most common adverse reactions (incidence greater than 2%) are hypotension, bradycardia, and dry mouth To confirm beyond use date for any medication, call pharmacy at: _____ Harmony Healthcare International (HHI) 430 Boston Street, Suite 104, Topsfield, MA 01983 Tel: 1.800.530.441 USP General Chapter <795> requires a Beyond Use Date (BUD) for all compounded pharmaceutical preparations. In the absence of literature data, the maximum BUD that can be assigned for an aqueous oral suspension is 14 days. This study was conducted to determine a BUD for Compounded Marbofloxacin Oral Suspension (MOS) in three conventional. Beyond-Use Date vs. Expiration Date In veterinary medicine, both beyond use dates (BUDs) and expiration dates provide important information about a medication's shelf life. Though they sound similar and interchangeable, there are key differences between BUDs and expiration dates that directly impact patient outcomes and practice purchasing.

(PDF) Beyond Use Date aiscpspa umy2017 - Academia

  1. e if the vaccine has a BUD. Examples of vaccines with BUDs: Reconstituted vaccin
  2. Topical Beyond-Use-Date Databank FORMULA NUMBER API BASE BUD F 004 661 Amitriptyline HCl 2%, Cyclobenzaprine HCl 0.5%, Piroxicam 0.5% PLO GEL MEDIFLO.
  3. A beyond use date that is not more than 60 days from the date of preparation of the customized patient medication package but shall not be later than any appropriate beyond use date for any medicinal drug included in the customized patient medication package. (c) The customized patient medication package can be separated into individual.
  4. beyond their original expiration date. The pro-ducts assigned to Groups 3, 4, and 5 had some lots that were denied initial extension. Overall, 2650 (88%) of the 3005 lots were extended past their original expiration date for an average of 66 months. Of these, 934 lots (35%) are still active and were granted an average extension o
  5. Abstract the establishment of both a beyond-use date and the extension of a beyond-use date need to be scientifically based. What is accepted as scientific evidence is at times misleading. the pharmacist may have the right to utilize some degree of professional judgment in both establishing and extending a beyond-use date, after a review o
  6. Exenatide BYETTA YES Prior to initial use, store under refrigeration at 2°C to 8°C (36°F to 46°F); after initial use, may be stored at room temp ≤25°C (≤77°F). Protect from light. Pen should be discarded 30 days after initial use Teriparatide FORTEO YES 28 days after initial use. Protect from light. Do not use if solution is cloudy
  7. istration of hazardous drugs since 2011, and recently implemented BUD of chemo/biotherapy SDV in concordance with the recent FDA approva

Assigning Beyond Use Dates - University of North Carolina


  1. imizing the medication wastage, while ensurin
  2. istration 3
  3. Beyond Use Date in Vial or Syringe for COVID-19 Vaccines (USP) [pdf] Vaccine Storage Troubleshooting Record (IAC) [pdf - fillable] Identification, Disposal, and Reporting of COVID-19 Vaccine Wastage (CDC) [pdf

Beyond Use Date (BUD) - Scrib

  1. Beyond-use dates for allergy extract dilutions should be based on the best available clinical data. Mixing of extracts with high and low proteolytic enzymes: Cross-reactivity of antigens: Separation of aqueous extracts with high proteolytic enzyme activities from other extracts is recommended
  2. f Beyond Use Date (BUD) adalah batas waktu penggunaan produk obat. setelah diracik/disiapkan atau setelah kemasan. primernya dibuka/dirusak. Kemasan primer. disini berarti kemasan yang langsung. bersentuhan dengan bahan obat, seperti: botol, ampul, vial, blister
  3. ation by the licensed healthcare professional supervising the repackaging process of an appropriate conta
  4. ed from the date or time the preparation is compounded.12 The point in time after which a compounded sterile preparation cannot be ad
  5. safety dari pasien
  6. Beyond-Use Dates (BUD) and Diffusimax® Revision Date: July 2021 Page 1 of 2 Drug Concentration (%) BUD Link (Click to Access) BUD (days) Amitriptyline 2% Diffusimax Diffusimax10 150 Baclofen 2% Diffusimax Diffusimax10 120 Capsaicin 0.02% Diffusimax Diffusimax10 30 Clonidine 0.2% Diffusimax Diffusimax10 60 Cyclobenzaprine 2% Diffusimax.

Beyond Use Date (BUD) Obat Racikan M

date printed on the label. Alternatively, vaccine may be stored under conditions below with reduced beyond use dates; beyond use dates must not exceed manufacturer expiration dates. Carefully track cumulative time vials are stored under these alternate conditions. Freezer and refrigerator storage may be easiest. Thermal shippers require significan For oral use only. Avoid contact with eyes. Keep container tightly closed. Keep out of the reach of children. Protect from light. Protect from freezing. The beyond-use date of the compounded product, as dispensed, when stored at refrigerated temperature is not later than 30 days To avoid the use of outdated drugs, CMS requires pharmacists to follow the manufacturer's directions regarding storage, stability, and beyond use dating in the official US Food and Drug Administration (FDA)-approved prescribing information (package insert) [§482.25(a)] beyond-use-date shall be one year from the date the drug is dispensed or the manufacturer's expiration date, whichever is earlier. The beyond-use-date may be placed on the prescription label or on a flag label attached to the bottle. A beyond-use-date is not required on the label of a prescription dispensed to a person at the time of release.

Results of Our Survey on Drug Storage, Stability

Click on the document link below to download the desired document. September 15, 2020 (New): Open Forum for Beyond-Use Date (BUD) Provisions in General Chapter <795> & <797> Presentation; Agenda; Roundtable Summary; July 21, 2020 (New): USP Stakeholder Engagement Plan on Beyond-Use Date (BUD) Provisions in General Chapters <795> & <797> Registration opened for September 15, 2020 Open Foru This study was performed to validate the instrumental method used for the determination of Beyond-Use Date (BUD) for F12373 Methimazole 2.5 mg/0.1 Gm to 10 mg/0.1 Gm Topical Lipoderm®. A Degradation study under stressed conditions and validation in compliance to USP acceptable criteria was conducted for this purpose. A Beyond-Use Date study wa dates, as additional stability data are available from the manufacturer. Remember, once the vial has been punctured, the vial will have a new beyond-use date (BUD) 12 hours from the time of puncture, that needs to be listed on the vial 5.9 Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists . 6 ADVERSE REACTIONS 6.1 Clinical Trial Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOG (D) The beyond use date assigned for sterility in section 1751.8. (3) For sterile compounded drug preparations, E extension of a beyond use date is only allowable when supported by the following: (A) Method Suitability Test, (B) Container Closure Integrity Test, and (C) Stability Studie

Beyond-Use Date Colistin (CMS) 10mg or 125,000 units -- Normal Saline 3mL 3 hours Polymyxin B 5mg or 50,000 units -- Normal Saline 3 mL 3 hours Amikacin 20mg 30mg Normal Saline 3 mL 3 hours Gentamicin 4mg 8mg Normal Saline 3 mL 3 hours Tobraycin 4mg 8mg Normal Saline 3 mL 3 hours. be aware of new personnel competencies, environmental monitoring and beyond-use dates. The chapter updates will require changes to departmental policies and procedures as well as periodic competency assessments. ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings Each preparation dispensed must have a Beyond Use Date (BUD) on the label The following are the BUD guidelines from USP <795> Non-aqueous formulation- 6 months Water containing non-oral - 30 days Water containing oral - 14 days, refrigerated All formulas need a source for BUD. If using one from above, site US Mengenali Perbedaan Expired Date VS Beyond Use Date Obat Rabu, 15 Januari 2020 13192 Obat menurut Food and Drugs Administration (FDA) adalah senyawa yang terdaftar dalam formularium atau farmakope resmi yang memiliki fungsi untuk mendiagnosa, mengobati, mengurangi keparahan, menyembuhkan, ataupun mencegah suatu penyakit

USP Stakeholder Engagement on Beyond-Use Date (BUD

  1. A REMS goes beyond a drug's written prescribing information and can include a Medication Guide, communication plan, and other elements to ensure safe use of a drug
  2. childbearing potential should be counseled on the consistent use of effective contraception. (2.1, 5.3, 8.1, 8.3) • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. (5.5) • TIVICAY tablets and TIVICAY PD tablets for oral suspension are not interchangeable. (2.3, 5.6
  3. reply: An expiration date reflects the stability of the product as prepared by the manufacturer; the beyond-use date (BUD) is the last date that a product can be safely used after it has been altered for patient use; for example, by combining it with another drug to create a compounded medication individualized for
  4. Maxima Pharmaceutical's Beyond Use Date (BUD) Program . Maxima is committed to providing BUD validation for a wide range of drugs and drug combinations in Diffusimax and Diffusimax 10. • Maxima has contracted with a reputable independent third-party with extensive experience in HPLC-chromatography drug assay
  5. Beyond Use Date, description of final product, components of the compound, the lot numbers and expiration dates of each component. Documenting lot numbers and expiration dates of the components must be done for all components in all compounded products. This is require

state board of pharmacy law and public safety . chapter 39 page 1 of 174 last revision date: 03/02/2020 . new jersey administrative code title 13 law and public safety chapter 39 . state board of pharmac 11.Beyond-Use Dates for all CSPs are assigned on the basis of direct testing or extrapolation from reliable literature and other documentation. 12.Procedures for measuring, mixing, dilution, purification, sterilization, packaging, and labeling conform to the correct sequence and quality established for the specified CSP Establishing Beyond-Use Dates Terminology - Expiration Date = applies to conventionally manufactured drug products - BUD = applies to Compounded Nonsterile Preparations calculated in terms of hours, days, or months Parameters to consider - Chemical and physical stability - Compatibility of container-closure system - Degradation of. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLIN Delivering Sheet Music Since 1876. Founded in 1876, J.W. Pepper is the best online store for sheet music with over a million titles to choose from. We offer printable sheet music for directors and performers alike as well as music equipment, accessories, and software to support your musical journey. ePrint, Pepper's digital sheet music, can.

Topical Beyond-Use-Date Databank S8 = Schedule 8 FORMULA NUMBER API BASE BUD F 004 661 Amitriptyline HCl 2%, Cyclobenzaprine HCl 0.5%, Piroxicam 0.5% PLO GEL MEDIFLO. the beyond use (expiry) date and time written on the syringe containing full strength BCG onto the empty 60 mL syringe 3. transfer 16.7 mL (1/3) of BCG suspension into the empty syringe 4. disconnect the syringe containing the 1/3 dose of BCG from the Syringe Fluid Dispensing Connector 5

(beyond use date) sifat fisika dan kimia stabil selama 24 jam pada suhu 25°C dan selama 4 hari pada suhu 2-8°C. Single use vial seftriakson yang telah direkonstitusi harus segera digunakan. 2 Expiration date larutan deksametason fosfat dalam single use vial yang belum dibuka adalah 2 (dua) tahun; sedangkan setelah diencerkan, beyond use date. Beyond its use-by date: Australia's System of fiscal equalisation, and how to reform it Submission to the Federal GST Distribution Review Julie Novak Research Fellow September 2011 . Institute of Public Affairs www.ipa.org.au 2 1.0 EXECUTIVE SUMMAR The establishment of both a beyond-use date and the extension of a beyond-use date need to be scientifically based. What is accepted as scientific evidence is at times misleading. The pharmacist may have the right to utilize some degree of professional judgment in both establishing and extending a beyond-use date, after a review of appropriate scientific literature @inproceedings{Cuwondo2008EvaluasiCP, title={Evaluasi cara penentuan beyond use date [masa edar] sediaan racikan pulveres campuran parasetamol dan fenobarbital dari rumah sakit X}, author={Cin Frengky Cuwondo}, year={2008} Record the date and time of first use on the vial label. Discard punctured vial after 12 hours. 1 of 3 2° to 8°C (36° to 46°F) 15° to 25°C (59° to 77°F) Let vial sit at room temperature for 15 minutes before administering Vial images for illustrative purposes only O

Mengenali Perbedaan Expired Date VS Beyond Use Date Obat

from microbial growth for more than five years from date of manufacture. During the course of a 28-day study, samples of Aquasonic 100 were stored both at room temperature, and at 36 - 38°C to simulate conditions in a Thermasonic® Gel Warmer. Samples under both conditions met the USP criteria for preservative effectiveness Use by dates are for ensuring safety and best before dates are for ensuring quality. Use by and best before dates are put on food labels to keep the consumer safe by allowing them to make informed decisions about the food and drink they are buying and consuming. Use by dates are on perishable food products such as meat products and ready. 4. Use numbers or metrics whenever possible. Numbers are concrete. They communicate a clear picture. By contrast, a large staff may be 20 or 200. If you are in charge of a large staff, budget, or region, use numbers to show how large it is meaningful use criteria around problem lists. Participants in the program are required to maintain an up-to-date problem list of current and active diagnoses based on ICD-9-CM or SNOMED CT codes. To comply, at least 80 percent of all unique patients seen by eligible providers must have at least one entry (or a

Truvada for PrEP Fact Sheet: Enduring Safe and Proper Us

Beyond Use Date (BUD). The BUD is 30 days at room temperature for oral mucosal preparations, and 14 days refrigerated for oral preparations (swallowed). The BUD must appear on the prescription label. Storage and Handling of Rx. Any appropriate storage and handling instructions must be included with the prescription. Training Documentation 1-Oct-2020. 1-Oct-2021. Dexmedetomidine HCl injection in 0.9% sodium chloride, 200 mcg/2 mL (100 mcg/mL), 2 mL single dose vial. Pfizer. 0409-1638-02. 95175DK. 1-Nov-2020. 1-Nov-2021. Epinephrine.


•The date the dilution or mixture was prepared • Full name of each drug and diluent in the container • Final concentration of each drugin mg/ml • Expiration dates of each drug and diluent • The Discard date for the preparation Unless otherwise specified by the manufacturer, the discard date is the earliest expiration date of drug or diluent in the container, or thirty (30 a. To execute an extension, use NAVPERS 1070/621 (or automated equivalent), which must be completed and signed by the member and an official authorized per MILPERSMAN 1070-190 prior to the date of expiration of enlistment. Agreements executed subsequent to the date of expiration of enlistment are without legal force and effect. b Use of electronic technology or telepharmacy by hospital. quantities and expiration dates required on labels. Sec. 20-617a. Flavoring agent added to prescription product. Sec. 20-618. (Formerly Sec. 21a-107). Repackaged drugs not considered . 6. Beyond Use Date adalah tanggal yang ditetapkan pada produk yang telah dibuka, di mana kondisi produk tersebut masih dalam rentang stabil dan masih dapat dikonsumsi. Untuk BUD tanggalnya tidak tertera. Waktu dimulai sejak obat sampai ke tangan pasien sampai maksimal hari yang sudah disebutkan di atas date marked on it has been passed, or if it is repackaged. Table 1 is a summary of the expiry dates of compounded preparations, as per APF. Specific formulas within the APF may have storage conditions and expiry dates which deviate from those listed in Table 1. Assigning an expiry date longer than 28 days should be based on reliable literature

Title [Company] Author: Mark Kieren Created Date: 11/1/2017 2:21:45 P A unit-of-use package that is a blister package may not be reprocessed by a pharmacist once it has been deblistered from a unit-dose container (see General Notices and Requirements for application of the appropriate beyond-use date for a multiple-unit or unit-dose container). Deblistering is the process of removing medication from a blister.

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vaccines and diluents in storage unit according to expiration dates Exceptions: • Reconstitution with a beyond use date or time (BUD) • Multidose vial with BUD once opened • Manufacturer-shortened expiration date. Vaccine Expiration Dates Original Development Date: Original Effective Date: Revision Date: July 11, 2016 1 of 1 | P a g e Proton Pump Inhibitors-Therapy Beyond 6 months Duration LENGTH OF AUTHORIZATION: Continuation of therapy: 6 months CLINICAL NOTES Prescription-only proton pump inhibitors are indicated for treatment and maintenance of duodenal ulcer

Beyond Use Date for creams and ointments I have the beyond use dates for tablets, liquids, vials, drops, etc etc. But I haven't been able to find a resource that mentions what the Beyond Use Date is for creams or ointments Except for use-by dates, product dates don't always refer to home storage and use after purchase. Use-by dates usually refer to best quality and are not safety dates. But even if the date expires during home storage, a product should be safe, wholesome and of good quality -- if handled properly and kept at 40 °F or below

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[PDF] Standards of practice, professional judgment, and

[PDF] Evaluasi cara penentuan beyond use date [masa edar

Search List of Extended Use Dates to Assist with Drug

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