Regulatory Compliance PHAR 841 – PHAR MACY PR AC T ICE MAN AGEMEN T WEEK 12 HOUR 1 R I CHAR D D’ASSALENAUX, PHAR MD 1 Objectives Examine the pharmacy manager's role in monitoring compliance with Local, State, and Federal regulations Demonstrate how policies can mitigate problems with regulations and protect patient privacy Organize the elements required to run a pharmacy business Your Name Here. NOT. May 2024 Edition of The Script (ca.gov) 2 Terms You Need to Know Pharmacist-in-Charge (PIC) Pharmacy Self-Assessment Title 22 DEA Form 222 CSOS Cures 3 Federal Laws Pure Food and Drug Act of 1906 The Food, Drug and Cosmetic Act of 1938 ◦ Durham–Humphrey Amendments, 1951 Prescription Drug Marketing Act of 1987 (PDMA) Omnibus Budget Reconciliation Act of 1990 Health Insurance Portability and Accountability Act of 1996 (HIPAA) 4 Federal Agencies Food and Drug Administration Drug Enforcement Agency Department of Health and Human Services Internal Revenue Service 5 State Laws The Pharmacy Law (Business and Professions Code 4000 et seq.) Board of Pharmacy Regulations (California Code of Regulations Title 16 Section 1700 et seq.) California Uniform Controlled Substances Act (Health and Safety Code 11000 et seq.) Confidentiality of Medical Information Act (Civil Code 56 et seq.) Public Resources Code Title 22 § 70263. Pharmaceutical Service General Requirements for Hospitals https://archive.org/stream/gov.ca.ccr.22.3/ca.ccr.22.3_djvu.txt ◦ NOTE: Search 70263 on Website. Go to 3rd result from search 6 California Agencies Board of Equalization http://www.boe.ca.gov/ (Property Tax) Secretary of State http://www.sos.ca.gov/ (Register Business) California Department of Fair Employment and Housing (DFEH) http://www.dfeh.ca.gov/ CURES https://oag.ca.gov/cures Board of Pharmacy http://www.pharmacy.ca.gov/ Department of Public Health https://www.cdph.ca.gov/ 7 Local Laws City Business License City Business Tax City Construction Permits Minimum Wage Law County Property Taxes NOTE: If business in unincorporated area of county, then county laws apply https://business.lacity.org/start-business/register-your-business https://www.lacounty.gov/business/starting-a-business-in-the-county 8 Starting a Business Visit the Small Business Administration https://www.sba.gov/starting-business/how-start-business/10-steps-starting-business 9 PIC = Pharmacist in Charge A legal definition 4036.5. Pharmacist-in-Charge “Pharmacist-in-charge” means a pharmacist proposed by a pharmacy and approved by the board as the supervisor or manager responsible for ensuring the pharmacy’s compliance with all state and federal laws and regulations pertaining to the practice of pharmacy. https://www.pharmacy.ca.gov/laws_regs/lawbook.pdf 10 PIC Duties 4113. Pharmacist-in-Charge: Notification to Board; Responsibilities (a) Every pharmacy shall designate a pharmacist-in-charge and, within 30 days thereof, shall notify the board in writing of the identity and license number of that pharmacist and the date he or she was designated. (b) The proposed pharmacist-in-charge shall be subject to approval by the board. The board shall not issue or renew a pharmacy license without identification of an approved pharmacist-in-charge for the pharmacy. 11 PIC Duties (c) The pharmacist-in-charge shall be responsible for a pharmacy's compliance with all state and federal laws and regulations pertaining to the practice of pharmacy. (d) Every pharmacy shall notify the board in writing, on a form designed by the board, within 30 days of the date when a pharmacist-in-charge ceases to act as the pharmacist-in-charge, and shall on the same form propose another pharmacist to take over as the pharmacist-in-charge. The proposed replacement pharmacist-in-charge shall be subject to approval by the board. If disapproved, the pharmacy shall propose another replacement within 15 days of the date of disapproval and shall continue to name proposed replacements until a pharmacist-in-charge is approved by the board. 12 No PIC? 4113. Pharmacist-in-Charge: Notification to Board; Responsibilities (continued) (e) If a pharmacy is unable, in the exercise of reasonable diligence, to identify within 30 days a permanent replacement pharmacist-in-charge to propose to the board on the notification form, the pharmacy may instead provide on that form the name of any pharmacist who is an employee, officer, or administrator of the pharmacy or the entity that owns the pharmacy and who is actively involved in the management of the pharmacy on a daily basis, to act as the interim pharmacist-in-charge for a period not to exceed 120 days. The pharmacy, or the entity that owns the pharmacy, shall be prepared during normal business hours to provide a representative of the board with the name of the interim pharmacist-in-charge with documentation of the active involvement of the interim pharmacist-in-charge in the daily management of the pharmacy, and with documentation of the pharmacy’s good faith efforts prior to naming the interim pharmacist-in-charge to obtain a permanent pharmacist-in-charge. By no later than 120 days following the identification of the interim pharmacist-in-charge, the pharmacy shall propose to the board the name of a pharmacist to serve as the permanent pharmacist-in-charge. The proposed permanent pharmacist-in-charge shall be subject to approval by the board. If disapproved, the pharmacy shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a pharmacist-in-charge is approved by the board. 13 1709.1. Designation of Pharmacist in Charge (a) The pharmacist-in-charge of a pharmacy shall be employed at that location and shall have responsibility for the daily operation of the pharmacy. (b) The pharmacy owner shall vest the pharmacist-in-charge with adequate authority to assure compliance with the laws governing the operation of a pharmacy. (c) No pharmacist shall be the pharmacist-in-charge of more than two pharmacies. If a pharmacist serves as pharmacist-in- charge at two pharmacies, those pharmacies shall not be separated by a driving distance of more than 50 miles. (d) No pharmacist shall be the pharmacist-in-charge of a pharmacy while concurrently serving as the designated representative-in-charge for a wholesaler or a veterinary food-animal drug retailer. 14 More 1709.1 PIC Designation (e) Notwithstanding subdivision (a), a pharmacy may designate any pharmacist who is an employee, officer or administrator of the pharmacy or the entity which owns the pharmacy and who is actively involved in the management of the pharmacy on a daily basis as the pharmacist-in-charge for a period not to exceed 120 days. The pharmacy, or the entity which owns the pharmacy, shall be prepared during normal business hours to provide a representative of the board with documentation of the involvement of a pharmacist-in-charge designated pursuant to this subdivision with the pharmacy and efforts to obtain and designate a permanent pharmacist-in-charge. (f) A pharmacist may refuse to act as a pharmacist-in-charge at a second pharmacy if the pharmacist determines, in the exercise of his or her professional judgment, that assuming responsibility for a second pharmacy would interfere with the effective performance of the pharmacist's responsibilities under the Pharmacy Law. A pharmacist who refuses to become pharmacist-in-charge at a second pharmacy shall notify the pharmacy owner in writing of his or her determination, specifying the circumstances of concern that have led to that determination. (g) A person employing a pharmacist may not discharge, discipline, or otherwise discriminate against any pharmacist in the terms and conditions of employment for exercising or attempting to exercise in good faith the right established pursuant to this section. 15 Self-Assessment Title 16 of the California Code of Regulations section 1715 requires the pharmacist-in-charge of each pharmacy licensed under section 4037 or 4029 of the Business and Professions Code to complete a self-assessment of the pharmacy’s compliance with federal and state pharmacy law. The assessment shall be performed before July 1 of every odd-numbered year. The pharmacistin-charge must also complete a self-assessment within 30 days whenever: (1) a new pharmacy permit has been issued; (2) there is a change in the pharmacist-in-charge; or (3) there is a change in the licensed location of the pharmacy. The primary purpose of the self-assessment is to promote compliance through self-examination and education. Example Self-Assessment questions on next few slides … https://www.pharmacy.ca.gov/forms/17m_13_2021.pdf 16 17 18 19 20 21 22 23 24 DEA Every pharmacy that dispenses controlled substances must register with the DEA (Form 224) https://apps.deadiversion.usdoj.gov/webforms2/spring/login?execution=e1s1 Form 106 is used to report theft or loss of controlled substances https://apps2.deadiversion.usdoj.gov/TLR/login.xhtml;jsessionid=OwihAJl17frIBGymP1_fjzqaEB3OCX3OMi wEajbd.web1 Form 222 is used to order schedule II controlled substances https://apps.deadiversion.usdoj.gov/webforms2/spring/orderFormsLogin?execution=e3s1 https://www.deadiversion.usdoj.gov/pubs/manuals/(DEA-DC-046)(EODEA154)_Pharmacist_Manual.pdf 25 DEA Record Keeping The records which must be maintained by a pharmacy are: 1.Executed and unexecuted official order forms (DEA Form 222) or the electronic equivalent 2.Power of Attorney authorization to sign order forms 3.Receipts and/or invoices for schedules III, IV, and V controlled substances 4.All inventory records of controlled substances, including the initial and biennial inventories, dated as of beginning or close of business 5.Records of controlled substances distributed (i.e., sales to other registrants, returns to vendors, distributions to reverse distributors) 6.Records of controlled substances dispensed (i.e., prescriptions, schedule V logbook) 7.Reports of Theft or Significant Loss (DEA Form 106), if applicable 8.Inventory of Drugs Surrendered for Disposal (DEA Form 41), if applicable 9.Records of transfers of controlled substances between pharmacies 10.DEA registration certificate 11.Self-certification certificate and logbook (or electronic equivalent) as required under the Combat Methamphetamine Epidemic Act of 2005 26 CSOS Controlled Substance Ordering System (CSOS) – Electronic Order Forms Any registrant permitted to order schedule II controlled substances may do so electronically via the DEA Controlled Substance Ordering System (CSOS) and maintain the records of these orders electronically for two years. The use of electronic orders is optional; registrants may continue to issue orders on a paper DEA Form 222. CSOS allows for secure electronic transmission of controlled substance orders without the supporting paper DEA Form 222. The adoption of the CSOS standards is the only allowance for the electronic transmission of schedule II controlled substance orders between controlled substance manufacturers, distributors, pharmacies, and other DEA authorized entities. CSOS uses Public Key Infrastructure (PKI) technology, which requires CSOS users to obtain a CSOS digital certificate for electronic ordering. The electronic orders must be signed using a digital signature issued by a Certification Authority (CA) run by the DEA. Digital certificates can be obtained only by registrants and individuals granted power of attorney by registrants to sign orders. A registrant must appoint a CSOS coordinator who will serve as that registrant's recognized agent regarding issues pertaining to issuance of, revocation of, and changes to, digital certificates issued under that registrant's DEA registration. A CSOS digital certificate will be valid until the DEA registration under which it is issued expires or until the CSOS CA is notified that the certificate should be revoked. Certificates will be revoked if the certificate holder is no longer authorized to sign schedule II orders for the registrant, if the information on which the certificate is based changes, or if the digital certificate used to sign electronic orders has been compromised, stolen, or lost. https://www.deaecom.gov/ 27 Combat Methamphetamine Act In March 2006, the President signed the Combat Methamphetamine Epidemic Act of 2005 (CMEA). As a result of the new law, the DEA issued an Interim Final Rule in the Federal Register on September 26, 2006, which outlined the retail provisions of the CMEA. Under the CMEA, regulated sellers must follow new requirements for retail sales of over-the-counter products containing the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine (PPA), which can be used to manufacture methamphetamine illegally. The CMEA defined "regulated seller" to mean a retail distributor (including a pharmacy and mobile retail vendors) and "at retail" to mean sale or purchase for personal use. 28 CMEA Requirements •Requirement of regulated sellers to place the products behind the counter or in locked cabinets. •Requirement of regulated sellers to check the identity of purchasers and maintain a log of each sale that includes the purchaser's name and address, signature of the purchaser, product sold, quantity sold, date, and time. •Requirement of regulated sellers to maintain the logbook for at least two years. •Requirement of regulated sellers to train employees in the requirements of the law and certify to DEA that the training has occurred. •Places a quantity limit of each of the chemicals that may be sold to an individual in a day to 3.6 grams of the chemical (base) without regard to the number of transactions. •For nonliquids, product packaging is limited to blister packs containing no more than 2 dosage units per blister. Where blister packs are not technically feasible, the product must be packaged in unit dose packets or pouches. •For individuals, purchases in a 30-day period are limited to 9 grams, of which not more than 7.5 grams may be imported by means of a common or contract carrier or the U.S. Postal Service. 29 CMEA Self-Certification While many states have enacted their own legislation regarding the regulation of these products, the federal law also requires regulated sellers to complete a self-certification process with the DEA that includes training their employees on the new regulations and procedures. The self-certification process must be completed online at www.DEAdiversion.usdoj.gov. If state law differs from federal law regarding the regulation of these products, retail outlets are to adhere to the stricter provisions of both. 30 HIPAA http://www.hhs.gov/hipaa/for-professionals/index.html 31 State and Federal Labor Law 32 Summary for Opening a Pharmacy Register business with the California Secretary of State http://www.sos.ca.gov/ Obtain a Employer Identification Number (EIN) from IRS https://www.irs.gov/ Register for a Seller’s Permit with the California Board of Equalization http://www.boe.ca.gov/ Obtain Pharmacy License from California Board of Pharmacy http://www.pharmacy.ca.gov/ Obtain a Business permit from the city https://business.lacity.org/start-business/register-your-business Obtain DEA number from the DEA https://www.deadiversion.usdoj.gov/index.html Perform CMEA Self-Certification https://www.deadiversion.usdoj.gov/meth/index.html Register as a PIC http://www.pharmacy.ca.gov/ Complete the Self-Assessment http://www.pharmacy.ca.gov/licensees/facility/self_assess.shtml Purchase and Post Labor Law Poster https://www.laborlawcenter.com/california-labor-law-posters Then go to work 33

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