Due to a constantly changing environment regarding controlled substances, the following recommendations are made to assist pharmacies with the dispensing of controlled substances. All rights reserved. Earlier this year, the AGs Office announced the formation of the Interagency Group on Illegal Prescribing, a coalition of state and federal agencies to investigate and prosecute prescribers, pharmacists and others who contribute to the opioid epidemic by illegally prescribing or dispensing pills. Note: The IDFPR license number is required for the registration with the DEA. When a registrant has controlled substances that are expired or unwanted the registrant should notify ORS. It does not store any personal data. When schedule II, III, IV and V medications are stored in a residents apartment or room, they must be stored with the residents other medications in a designated and locked storage area. 8. Participates in controlled substances inventory management in the Pharmacy and the hospital. Washington State requires all controlled medications to be stored in such a way that no resident can access another residents medication. cy fr-m-s plural pharmacies 1 : the art, practice, or profession of preparing, preserving, compounding, and dispensing medical drugs 2 a : a place where Schedule 3-5: The drugs under these schedules have less as compared to the above potentials for abuse, are accepted for medical treatment, and have less physical dependence and psychological dependence (e.g. You also have the option to opt-out of these cookies. This is called as storage record of a nursing unit. Upon removal from the registrants location, ES will notify ORS and ORS will update the Controlled Substances Database. %%EOF Its a collection of policies and procedures for your pharmacy, so customize and organize your manual to fit your pharmacys needs and to address challenges specific to your practice. Creating such a ORS will follow up with the registrant if the required inventories are not entered into the Controlled Substances Database in a timely manner. Each finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter); The number of units or volume of each finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and. Please remove any contact information or personal data from your feedback. Public Health Code - Article 7 - Controlled Substances. MassPAT, the newly redeveloped PMP online system, is one of the most essential tools prescribers and pharmacists have at their disposal.. In determining the number of units of a controlled substance in a commercial container that has been opened, the registrant shall, if the substance is listed in Schedule I or II, make an exact count or measure of the contents. 0 1444 0 obj <>/Filter/FlateDecode/ID[<0F21AD11D7253744824AFEC09C42ECEE><0FC93FA95C5C904F8EECF40D37701AAD>]/Index[1405 82]/Info 1404 0 R/Length 159/Prev 424491/Root 1406 0 R/Size 1487/Type/XRef/W[1 3 1]>>stream Depending on their respective schedules, controlled substances are required to be stored in securely locked, substantially constructed cabinets or safes (i.e., not easily broken into or moved; see 21 CFR 1301.71). SCOPE: Pharmacy KEYWORDS: Staffing, coverage, 5. endstream endobj 28 0 obj <> endobj 29 0 obj <. Registration of a controlled substance is linked to its storage and usage location. Therefore, changes of address and/or location of the controlled substances (e.g., a faculty member moves into a new lab) must be reported to the DEA and the IDFPR as soon as possible. December 31, 2021 by Sujay Mistry. hbbd```b``Q AD2H`\Vvgx40[6 `l(,H2@"I?v9do>6DW `sl1F+Xyf20 ?7 D Pharmacists must continue to provide necessary medications to patients while ensuring that the amount of controlled substances being dispensed is appropriate. The Office of Research Services (ORS) will be responsible for assisting individuals engaged in research in complying with applicable rules and regulations. hXmo6+bh$Ydiri]&jb3kHK\_ bZHJzD2/ ## cxdDhG$YR,eHI4GRYfM dpO 4+`U'`)PpKsYJOh"`C%kF|vWP%R>k "-^k"}C)Q(P!PR@QCKK$?Dzjp"3#I1MAAx~A0nsPcAd*C3 L0EEicsy4(\1c1=gL(;>Ov<8NSq]&yR&nj1r*y^pLn#zV$=0fp:kxTknwNjC'W,g0t7)YOh@1j1FF ]&yM;-'eZZ{6 iK"*)hzW({B_ThBS ,6K?Ns@Z.3@T1gQ5alj+vK&k'XdVeoqqIp+8Fb;:Hivp."/X$s]g_N?_s`q>]ZkgIN,352_CV\E.5TY @0-4_'(Yvi7=P|bsa2Lz,V8!Ay$sH|{sa_Z,H*?~RW%YVfua \l8ioB. 15. %PDF-1.6 % The applicant will then be notified by ORS to proceed with the registration with the IDFPR and the DEA. Pharmacy. Pharmacy 2022 Board Meetings. Pharmacists need to maintain the records of the receipt and return of controlled drugs for disposal. Policy & Procedure: Controlled Substances Part 1, For more information on how to handle controlled substances, visit the. We are seeking a Certified Pharmacy Technician for this particular This case was handled by Deputy Division Chief and Chief of Investigations Kevin Ready, Assistant Attorney General Stephany Collamore, and Investigator Chris Cecchini of the AGs Medicaid Fraud Division, Assistant Attorney General Colleen Nevin of the AGs Consumer Protection Division, and James OHara of the AGs Investigations Division. Investigates discrepancies and troubleshoots malfunctions in automated dispensing To access Pharmacy, you must be signed into your personal My HealtheVet account. Free two-day delivery, too. 2 Plus, for most prescriptions, you can get a 3-month supply for the price of 2 months. CVS Pharmacy to Strengthen Policies Around Dispending Opioids and Require Use of Prescription Monitoring Program in Groundbreaking Settlement. Protecting Patient Access to Emergency Medications Act of 2017 signed into law November 17, 2017. The number of commercial containers of each such finished form (e.g. 204.11 Ninety (90) Day Supply . endstream endobj 1406 0 obj <>/Metadata 66 0 R/Names 1446 0 R/OpenAction 1407 0 R/Outlines 175 0 R/PageLayout/SinglePage/Pages 1399 0 R/StructTreeRoot 186 0 R/Type/Catalog/ViewerPreferences<>>> endobj 1407 0 obj <> endobj 1408 0 obj <>/Font<>/ProcSet[/PDF/Text/ImageC]/Shading<>/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/TrimBox[0.0 0.0 612.0 792.0]/Type/Page>> endobj 1409 0 obj <>stream Harmons Dietitians Harmons Dietitians help us make the best choices for long-term health. Many of the more than 350 CVS pharmacies in Massachusetts are MassHealth providers and therefore must comply with all applicable state and federal statutes and regulations governing its participation in the program. Pharmacists struggling to reconcile their duty to dispense To effectively combat the opioid epidemic that is claiming lives and devastating families and communities across our state, we must work together to use all tools at our disposal, said AG Healey. That in turn provides great benefit for patients as well as clarity to pharmacists whose organizations stock and restock controlled substances for EMS organizations. MassHealth administers the CSMP, a program for its members who use large quantities of prescribed drugs. . This website uses cookies to improve your experience while you navigate through the website. organization has locations with multiple Drug Enforcement Administration (DEA) licenses, all organizational policies and procedures related to the CSDPP should be applied consistently. Many substances that are used for legitimate medical and scientific research purposes are otherwise illegal. Otherwise, your pharmacy is legally required to not deliver the medication. Occasionally such patients require drugs for use at home and in such cases dispensing of drugs can be done only on a prescription which must be signed by the staff who is a registered medical practitioner and also authorized to prescribe controlled substances for this purpose. Under these circumstances, the department or unit head responsible for that location will, in lieu of the registrant, need to follow the procedure outlined under Disposal above. 204.10 Blood Clotting Factor . (5) Medication Waste: (A) Damaged partial or full-dose medications shall be wasted on a per patient basis and recorded in the ADC at the time of retrieval. 1 This law modified the 3719.013 hbbd``b`y$s@- T$Xz "AD HO101q` G6 It is the responsibility of the registrant to ascertain that the new address and location(s) of controlled substances coincide on all relevant forms and databases. On receipt of patient named CDs from the Pharmacy provider two RNs must check the delivery is correct against the Pharmacy delivery notes. As a part of these settlements, CVS has also agreed to make a payment of $795,000 to the state, $500,000 of which will be used to address opioid dependence and addiction in Massachusetts. Simple and fast controlled substance workflow saves hours of nursing time each day. Public Health Code - Pharmacy Section The primary pharmacy is required to monitor the prescription use pattern of each CSMP member and use sound professional judgment when dispensing all prescription drugs. If you need assistance, please . Solution Pharmacy is a Medical & Pharmacy Information Website. Use a simple binder with alphabetically indexed inserts; these are available at drug stores and office supply stores. Moreover, this serves to bring clarity to an important issue that has raised many questions over the years. CVS Pharmacy to Strengthen Policies Around Dispending Opioids and Require Use of Prescription Monitoring Program in Groundbreaking Settlement Pharmacy Chain to The feedback will only be used for improving the website. The Controlled Substances Act ( 21 USC Chapter 13) regulates such use, and 21 CFR 1300-1399 promulgates federal regulations to implement that statute. Drugs that are not needed to be stocked in the nursing station may be ordered from the pharmacy unit on the written prescription only by mentioning the total quantity along with duly sign of the doctor. four 100-tablet bottles or six 3-milliliter vials). Focus on But opting out of some of these cookies may affect your browsing experience. The Protecting Patient Access to Emergency Medications Act of 2017 Spells Out Appropriate Dispensing Procedures. It is the responsibility of the registrant to enter the following information into the Controlled Substances Database and to keep such information up to date: In addition to the continuous recordkeeping requirements listed above, initial and biennial inventories are required. 6-15 SupplementRegulations and Standards Included in This Section 1. Under this amendment to the Controlled Substances Act, patients can receive the care they need in a more streamlined and efficient manner. 3719.34 Provisions inapplicable. controlled substance to cover a full 90 day script will contain the earliest refill date at 30-day intervals such that the pharmacist will know the earliest date when the refill may be completed. AG Healey sent a lettersupporting the CDCfor drafting guidelines that will provide much-needed information to primary care providers across the country about when and how opioids should be prescribed for chronic pain creating a single, nationwide, evidence-based standard. 204.9 Administration of Vaccines . 1 Same-day or next-day delivery is also an option for most prescription orders for an additional fee. The guidelines proposed by the CDC make clear that addictive opioids should not be the initial treatment for chronic pain and should only be used where their benefits outweigh the risks. NO prescription for a controlled substance shall be authorized by telephone. This also means that the medication will only be delivered to an assisted living community after the pharmacy has the prescription in hand. For Schedule I and II drugs, the request will include a completed DEA form 222. Schedule 1: The drugs under this schedule have a high potential for abuse and have no accepted medical use in treatment (e.g. An initial inventory shall include: Damaged, defective, expired, or impure substances awaiting disposal must also be inventoried including name, total quantity, and the reason why the substance is being maintained. 3719.28 Rules for administration and enforcement. Many states have laws that require every pharmacy to have a current policy and procedures manual. A lock icon ( All applicants must submit a copy of their DEA registration to ORS, which will then update the Controlled Substances Database. As far as the DEA is concerned, the registrant, not the institution, is solely responsible for ensuring that any rules and regulation pertaining to the use of controlled substances are implemented. Quality assurance manual, reporting template, Prescription Intake for Oral or Electronic Prescriptions for Schedule II Drugs for Inpatients, Handling, Receiving, and Dispensing Controlled Substances, Compliance with Title 7 Combat Methamphetamine Epidemic Act of 2005, Non-licensed employee theft, robbery, or loss of controlled substances, Administration of Immunization by Injection, Verifying licensure and exclusion database, Inventory Reconciliation Reports of Controlled Substances Reporting Discovered Losses, Handling, Receiving, and Dispensing Controlled Substances. Fire Service Based EMS Advocates website. The PMP, a secure website maintained by DPH, collects dispensing information on certain controlled substances, including opioids, dispensed pursuant to a prescription. The cookie is used to store the user consent for the cookies in the category "Other. Pharmacy Chain to Pay Total of $795,000; AGs Office to Direct $500,000 of Settlement to Address Opioid Dependence and Addiction. Policies benefit the pharmacy team even more than the pharmacy owner because they keep the pharmacy operations running efficiently. F. MATERIAL(S) NEEDED: None . The application is reviewed by the DEA and can be either accepted or denied.3 With an approved application from the DEA, the EMS organization can store, deliver, and receive controlled medications.1 These controlled medications can then be given to the patient when they are en route to the hospital.1 Furthermore, instead of applying for a new registration through the DEA for each separate EMS facility, an EMS agency may obtain a single registration in each state instead of a separate registration for each location.3, An EMS agency must adhere to 3 regulations to stay compliant with the application it submitted to the DEA. Documentation/recording of the return of controlled drugs for demolition by the pharmacist from the respective ward of the hospital is considered a good practice of record. The cookie is used to store the user consent for the cookies in the category "Analytics". We will use this information to improve this page. Pharmacy Rules Committee Work Group. Delivers medications to clinic procedural treatment operating room and patient care areas . Initial and biennial inventories must be entered by the registrant into the Controlled Substances Database; hard copies must be printed out by each registrant and kept at the location where the substances are stored. For example, if the registrant is approved for the use/purchase of schedule II non-narcotic drugs (e.g. 0 Manages users within the automated dispensing technology database as per policy. 3 The biennial inventory date must be within two years of the last inventory. 2023 MJH Life Sciences and Pharmacy Times Pharmacy Practice News and Expert Insights. ) or https:// means youve safely connected to the official website. The AGs Office continues to work on solutions that include eliminating barriers to treatment and supporting prevention and education initiatives across the state. 1486 0 obj <>stream %PDF-1.6 % However, occasionally, faculty will leave without appropriately disposing or transferring all controlled substances from their lab or other location. (Some companies/communities require CIV and CV to be under double lock as well. The registrant should maintain a log book of who has access to controlled substances in their lab, and the substances and amounts used. Pharmacy Guidelines for the Use of Controlled Substances for the Treatment of Pain. Please limit your input to 500 characters. ORS will forward the request to Purchasing on behalf of the registrant. Prevention and education are essential pieces to ending this epidemic., The opioid crisis is an epidemic one we must address through smart health interventions across prevention, intervention, treatment, and recovery, said Dr. Monica Bharel, Commissioner of the Department of Public Health (DPH). Protecting Patient Access to Emergency Medications Act of 2017, HR 304, 115th Congress, Sec 2 (2017-2018). Saves pharmacy time spent resolving discrepancies. Please do not include personal or contact information. 59 0 obj <>stream Handles all controlled medications following federal and legal requirement as set through policy and procedure. Refill VA Prescriptions. The U.S. Department of Justice affects pharmacy practice through its 1338 0 obj <> endobj %%EOF Pharmacy is the science and practice of discovering, producing, preparing, dispensing, reviewing and monitoring medications, aiming to ensure the safe, effective, and affordable use of medicines. The Controlled Substance Dispenser stores medications in a secured area in the automated dispensing cabinet and dispenses each dose into a special drawer where nurses can easily access it. Current information on the initial application fee and biennial license fee for the IDFPR is found at http://www.ilga.gov/commission/jcar/admincode/077/077031000000300R.html. The required forms and detailed instructions are available on the DEA website: http://www.deadiversion.usdoj.gov/drugreg/reg_apps/index.html. Every time your community receives a new controlled medication, create a controlled drug administration record. Initial and biennial inventories must be kept for two years from the date the inventory was conducted. The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. While it is necessary to take such order by a nurse on doctor order sheet by stating it is a telephone order along with mention of the complete name of the doctor with initial of a nurse. iv. RQ Email: admin@abcaccreditationmanuals.com. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. Registrants may only order controlled substances by completing the Controlled Substances Purchase Request on the Controlled Substances Website. The Office of The PMP is one component of a larger effort to address the opioid epidemic in Massachusetts. According to the law, an EMS organization must submit an application to the Drug Enforcement Administration (DEA).3 This application is for registration and for demonstration that the applicant organization can provide the needed services in the specific state. We also use third-party cookies that help us analyze and understand how you use this website. Loyola faculty or staff who seek to obtain controlled substances (at this stage, the applicant) must first complete the Controlled Substances Registration Request form on the LUC Controlled Substances Website [available within ORSs Compliance Approval Portal (CAP) at https://cap.luc.edu/Secure/Login.aspx]. endstream endobj 2790 0 obj <. Your pharmacy can only dispense controlled substances after receiving a written prescription. q^hy`x]b Fd`sB3mY9E@pAq GLjv' @,?H3@ ) The AGs Office further alleges that some of these transactions occurred despite a prior denial by MassHealth of a claim for the same controlled substance on the same day. Illinois has its own Controlled Substances Act, which follows and supplements the federal law. 2802 0 obj <>/Filter/FlateDecode/ID[<997DA5647022274292CC1402443D91E5>]/Index[2789 23]/Info 2788 0 R/Length 81/Prev 502655/Root 2790 0 R/Size 2812/Type/XRef/W[1 3 1]>>stream Such accountability of controlled substances needs to furnish to the pharmacy department while a request for a new supply of drugs. Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features. Controlled substances in Schedules III, IV and V may also be dispensed by a pharmacy pursuant to an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required [for a valid prescription], except for the signature of the practitioner. 21 CFR 1306.21 (a). Many substances that are used for legitimate medical and scientific research purposes are otherwise illegal. l93FrbQV444uR Share sensitive information only on official, secure websites. This will include educating researchers about the requirements, maintaining the controlled substances website as described below, and providing regular oversight to insure compliance, Registration Request Form and Controlled Substances Database. Name of the prescriber and their signature. During handling of control substances, the following duties should be performed administration department. endstream endobj startxref Purchasing may require additional information from the registrant in the case of initial orders and amendments to initial orders for use of controlled substances in research (see 21 CFR 1301.18 and 1301.32). 6. 0 (6y%PV nne_%I U:]n@=w#% k} Schedule 1 is the most addictive and includes such drugs as heroin, peyote, and certain morphine derivatives. 5. v. NO prescription for a controlled substance shall be dispensed through hbbd``b`z$` H+Ab D KD(ZbVYd0 b 2 hb```b``^[ ,@QF ?AU`6cPl]Jgk^zSo-K Investigates discrepancies and troubleshoots malfunctions in automated dispensing technology. Save my name, email, and website in this browser for the next time I comment. To ensure accountability, a complete and accurate continuing record is required for each substance and must be maintained by the registrant on a current basis. The average pharmacy Amazon Pharmacy Accepts most insurance plans Reviewed by pharmacists Automatic refills Available to you 24/7 Shows prices upfront Delivers to your door Meds are as low as $1/month Offers 6-month supply Even more for Amazon Prime members When paying out of pocket, Prime members can save on medication. Biological Clock And Their Significance Leading To Chronotherapy, Role and Responsibility of Administration, Policies and Procedures for Ordering of Controlled Substances, Procedure for Dispensing of Controlled Substances for In-Patients, Ordering Non-Ward Substances from Pharmacy, Prescribing of Control Drugs in Out Patient Department (OPD), Dispensing of Control Drugs for House use when Pharmacy is closed. 204.8 Copay only Billing . The registrant would need to go through the DEA and the IDFPR first to get this approved. OF~FE>6bw. This page is located more than 3 levels deep within a topic. )@8+5H]wE3\3r`!XY::-` & Ri@#qeA`@l>AfL`.! The head nurse should enter the information of control substance administration within 24 hours in a daily basis administration form. A .mass.gov website belongs to an official government organization in Massachusetts. Necessary cookies are absolutely essential for the website to function properly. Utilizziamo i cookie sul nostro sito Web per offrirti l'esperienza migliore ricordando le tue preferenze. After receiving an IDFPR license, the applicant must register with: In addition to registering with IDFPR, applicants must be registered with the Drug Enforcement Administration (DEA). While the nurse must write such verbal order on the doctors order sheet and later on duly sign by a doctor within 24 hours. Pharmacy 2023 Board Meetings. (D) Controlled Substances require a witness to return and a detailed return explanation to be entered. LUC faculty and staff engaged in research that involves the use of DEA controlled substances will be responsible for registering with the DEA and IDFPR, updating the controlled substances database as described below, and for assuring compliance with applicable state and federal regulations. Use tab to navigate through the menu items. When the controlled substances are received, the registrant must enter the necessary information in the Controlled Substances Database. Loyola University Chicago requires that all LUC faculty and staff conducting activities with DEA controlled substances be registered with the DEA and IDFPR and comply with state and federal regulations regarding the acquisition, storage, use and disposal of those substances. Annual Policy and Procedure Authorization Page Pharmaceutical Services Subcommittee Roster I. Here, our Pharmacists provide more than just prescriptions and over-the-counter medications they provide advice and support. Although ORS will maintain records and databases, and conduct on-site inspections, it is the registrants responsibility to ensure that databases are up to date. Usa il codice e approfitta del 30% di sconto su tutti i corsi singoli. Accessed December 27, 2018. Those patients are in addition to individuals with other emergencies, such as heart attacks, seizures, and injuries from serious accidents. Scheduled II and III medications that are managed by Assisted Living must be doubly locked. Pharmacy Operational Manual includes pharmacy policies and procedures as required under California and federal law, as well as most policies required by PBM manuals. Current information on the fee for annual renewal of the DEA registration is found at http://www.deadiversion.usdoj.gov/drugreg/categories.htm. The Office of Diversion Control in the U.S. Drug Enforcement Administration (DEA) enforces these regulations. 46 0 obj <>/Filter/FlateDecode/ID[<084F39E70AFF8643AA594950FD083AB6><24D9145C8AF3054292C0940A35934584>]/Index[27 33]/Info 26 0 R/Length 90/Prev 69812/Root 28 0 R/Size 60/Type/XRef/W[1 2 1]>>stream The registrant may request, via the Controlled Substances Database, that additional LUC employees who are supervised by the registrant (within the same department and registered physical location) be authorized to use the substances for approved activities. Consult with your own policies and procedures.). (B) Controlled Substances require a witness to waste and a waste comment to 3719.32 Regulating the sale of poisons. Mass.gov is a registered service mark of the Commonwealth of Massachusetts. 3719.30 Prohibition against leaving or depositing dangerous drug or poison on thoroughfares. Whether the inventory was taken at the beginning or close of business. An official website of the Commonwealth of Massachusetts, This page, CVS Pharmacy to Strengthen Policies Around Dispending Opioids and Require Use of Prescription Monitoring Program in Groundbreaking Settlement , is, for CVS Pharmacy to Strengthen Policies Around Dispending Opioids and Require Use of Prescription Monitoring Program in Groundbreaking Settlement. Prescription Monitoring Program: All SC-permitted pharmacies must also register with SCDHEC-Bureau of Drug Control Prescription Monitoring Program. 27 0 obj <> endobj Tuttavia, puoi visitare "Impostazioni cookie" per fornire un consenso controllato. Both nurses should sign and date both of the In case of issues or problems with the request, ORS will contact the applicant to get these resolved. Novel Immunotherapy in Up-front Setting Shows Improved Outcomes in ALL, January 2023 Over-the-Counter Product News, Employer Inquires About Pharmacists Retirement Plans, Joseph L. Fink III, BSPharm, JD, DSC (Hon), FAPHA. endstream endobj startxref %PDF-1.6 % These requirements are covered in this policy. Dispensing of Controlled Drugs: A controlled substance is a drug or chemical which ownership, manufacture, or use is regulated by a respective government of countries such as illegally used drugs or prescription medications. If you would like to continue helping us improve Mass.gov, join our user panel to test new features for the site. Controlled substances require extra attention for everything from ordering, receipt and recordkeeping to actually dispensing the medication. Examine controlled substance inventory management. In Solution Pharmacy all Materials are Provided for Educational Purposes Only. For more information on how to handle controlled substances, visit the Washington State Legislatures website. On-site inspections will be made at least annually by ORS to ensure that registrants have properly fulfilled these responsibilities. Narcotics and controlled drugs on wards by a nurse. Our Mission is to deliver high-quality compliance documents and assist with pharmacy compliancein the most cost-effective way. Through enrollment in and utilization of the PMP, doctors and pharmacists can access patient prescription history information which can be used to assist in clinical decision-making and to prevent or stop the abuse or misuse of controlled substances. The PMP provides the prescription history of a patient that can help identify drug-seeking behavior. Contact PMP at scripts@dhec.sc.gov or (803) 896-0688. After the initial inventory, a new inventory must be taken by the registrant at least every two years. Job Summary and Scope. The Pharmacy Technician, Controlled Substance reflects the mission, vision, and values of NMHC, adheres to the organizations Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.
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