Oregon Law: Responsibilities of Pharmacists and Staff - PDF

Oregon Law Responsibilities of a pharmacist and non-pharmacist personnel ○ PIC is responsible for all operational aspects of pharmacy (policies & procedures) to prevent/reduce errors, annual self inspection, oversight of staff, establishing controls to prevent diversion, annua...

Oregon Law Responsibilities of a pharmacist and non-pharmacist personnel ○ PIC is responsible for all operational aspects of pharmacy (policies & procedures) to prevent/reduce errors, annual self inspection, oversight of staff, establishing controls to prevent diversion, annual CS inventory, quarterly inventory of C2 (every 93 days) quality assurance plan, maintenance of rx files, notifying board of staff violations ○ PIC must have completed 1 yr of practice or a PIC training course, could be PIC for < 3 pharmacies at a time ○ When changing PIC within 15 days must report to board, do self inspection, inventory of CS ○ Precepting max of 4 interns at a time when doing direct patient care activities, more are allowed for non-patient care activities ○ Consultant pharmacists: may store records at a licensed pharmacy or may become licensed "drugless" pharmacy Qualifications, scope of duties, limitations, restriction of duties, conditions to practice for non-pharmacist personnel ○ Tech must be identifiable to public as a tech, may not access pharmacy until pharmacist is there ○ Techs may: preform final verification of drug (but not use discretion/judgment), affix labels, reconstitute, accept oral refill authorizations if no changes, repackage multi dose drugs; must clearly be identifiable as techs, may not access pharmacy when there is no pharmacist on duty, may only receive/transfer rx with prior pharmacist verification; ○ Techs may not: accept oral rx from prescriber, counsel pts on any meds ○ No max pharmacist: tech ratio, can supervise as many as the pharmacist believes is reasonable and safe.  ○ Intern license renewal: need 2 hours CE in cultural competency, annual background check ○ Interns need 1440 hours of school based rotational internship and 1 hours of CE in pain management, must also undergo criminal background check with fingerprints, must disclose arrests/charges/convictions ○ Intern may: perform all same activities of a pharmacist (such as administer vaccines, transfer CS rx over the phone, receive rx from provider except for prescribing a drug/device through a protocol and performing final drug verification Licensure, registrations and certifications for pharmacists or non-pharmacist personnel ○ Pharmacist license expires june 30 of the odd number years, renew biennially ○ Pharmacist license renewal: 30 hours CE in previous 2 years & cannot carry over hours CE requirements: 2 hours in pharmacy law, 2 hours in patient safety / med errors 2 hours of cultural competency ], 1 hour in pain management Must keep CE records for 6 years and provide documentation if requested ○ Pharmacist must notify board within 15 days of changing email address, employment location, residence address ○ Classification and processes of disciplinary actions : board may suspend/revoke license for violating oregon pharmacy act or unprofessional conduct, such as being found guilty of felony, being impaired, gross negligence etc, must report to board conviction of misdemeanor/felony or if arrested for felony within 10 days  ○ Reporting to and participating in programs addressing the inability to practice with reasonable skill and safety: health professional service program for impaired pharmacist/interns board may refer you or you can refer yourself , not free pharmacist must cover cost in general the program is 2 years minimum, maybe longer if board says so Requirements for issuing prescriptions/drug orders ○ Requirements for drug uses, limitations or restrictions: all rx must be issued for a legit medical purpose in the prescriber's scope of practice. Patient-provider relationship is required. Corresponding liable rests upon pharmacist who fill prescription, if its not properly prepared or not issued for legit purpose or out of scope ○ Scope of authority, scope of practice, limitations or restrictions of practice and valid registration of practitioners who are authorized to prescribe, dispense or administer drugs any prescriber that prescribes CS must have their own DEA number included on rx All prescribers must always prescribe in scope of practice PA may prescribe any drug (including CS) which supervising physician has determined as okay, need PA DEA# on prescription APRN may prescribe any drug (including CS) independently, need DEA# for CS Optometrist may issue tx for C3,4,5 for conditions related to the eye, for C2 hydrocodone combo drug only (no other C2) ○ Requirements for issuing non-controlled prescriptions/drug orders Must contain physician's signature (or e signature) and be within the scope of practice Expiration date of non-CS prescriptions is 12 months from the date of issue May combine valid refills available into 1 larger dispensing if rx is not cs nor psychotherapeutic drug, must notify prescriber of this Pharmacist may make emergency refills NTW 72 hour supply if prescriber not available and patient needs refill only for non-CS Auto refills: no CS allowed patient must approve each rx and patient may request to end it Needles and syringes may be sold to age > 18 without rx, if < 17 must be lawful need, to any age with rx Emergency insulin may be prescribed/dispensed by a pharmacist who has completed an ACPE-accredited training program, pt must have evidence of previous insulin rx, may dispense < 30 day supply NTE 3x per year ○ Requirements for issuing controlled prescription/drug orders CS may be issued electronically but it is not required in oregon, paper prescriptions for C2-5 are valid, telephone tx for C3,4,5 is valid Rx for C2 may not contain refills Multiple prescriptions for C2 may be issued on the same day (same issue date) but with “do not fill until [date]” and each rx is valid, authorizing up to a 90 day  supply. Each rx becomes invalid 30 days after the “do not fill until” date Rx for C2 may be sent by fax for LTCF pt, pt in hospice, compound for direct pt administration. If a C2 is faxed but it is not for one of these categories the pharmacist must be presented with the original prescription prior to dispensing C3,4,5 limited to 5 refills or 6 months from issue date, whichever comes first ○ Authority limitations of practitioners ability to authorize refills Prescriber cannot issue rx to obtain stock of CS for their own dispensing to pt directly C2 cannot contain refills, C3,4,5 may contain up to 5 refills ○ Conditions under which the pharmacist or non-pharmacist personnel participates in the administration of drugs in the management of the patients therapy Pharmacist can test & treat for COVID effective october 1 2024 (despite PREP act) Pharmacist may administer drugs pursuant to rx or CDTM or protocol if properly trained on drug administration, observes/monitors the patient for AE, keep administration record for 3 years min Collaborative drug therapy management (CDTM) contract: outline types of diseases/drugs involved, plan for communicating with the provider, the contract may include therapeutic substitution within CDTM Pharmacists prescribing (via compendium) must develop a patient centered plan, notify the provider within 5 days, and keep records for 7 years. May not  prescribe for family, may not require pt to schedule appt for hormonal contraceptives When prescribing hormonal contraception through the state protocol pharmacist must fax documents to the patient's HC provider within 5 days of the visit. Must also give the patient a “patient visit summary” to take away ○ Requirements regarding counseling Counseling must be offered for new rx and if previous rx has changes; if pt declines pharmacist must document that offer was made Alternative forms may be used to supplement counseling such as videos, printouts etc Counseling is not required for inpt of a hospital Documenting counseling or documenting offering to counsel: if pt declines pharmacist must document that the offer was made in the pt profile ○ Returning or reusing drugs Retail pharmacy may not accept returned drugs from patient for redispensing once dispensed Some exceptions for donations may apply, but pharmacy has to be enrolled in the “medication donation” program, charitable clinics and prison pharmacies can return drugs. In general retail pharmacies cannot return meds non - CS drugs can be returned to retail pharmacy only for destruction/disposal Regulations and agencies regarding pharmacy practice ○ Requirements for promoting quality and safety of public health: Pharmacist mat dispense naloxone to any person or when dispensing opioid > 50 MME; does not need to  be dispensed to a individual pt, any person with naloxone can distribute it prn Mus provide oral counseling regarding opioid overdose prevention, recognition, response Pharmacist may dispense early refill for a med for opioid use disorder: 1 refill in 12 month period if rx expired OR Up to 3 refills of current rx if pt has lost/had stolen med Pharmacist must preform pt assessment, must inform pt’s PCP/prescriber To be eligible to administer vaccines pharmacist must complete a training program, have a current BLS/CPR certificate on site, must report vaccine to OHA ALERT within 15 days Pharmacist can administer vaccines to patient 7 years of age and older (without a prescription) through the oregon health authority protocol Can administer as young as 6 months for flu shot only If public health emergency can administer to age >3 ○ Protecting patient and health record confidentiality Violating patient confidentiality is a violation of professional conduct, may subject pharmacist to disciplinary action and fines Can release patient info to another provider who is actually providing care to that patient, may also release if there is a legal requirement (legit law enforcement inquiry ect) Must give pt notice of any privacy practices before serving them in the pharmacy  Responsibilities for determining whether prescriptions/drug orders are issued for a legitimate medical purpose and within all applicable restrictions ○ All rx must be issued for a legit medical purpose in the prescriber's scope of practice , patient provider relationship is required. Corresponding liability rests upon pharmacist who fills prescriptions not prepared properly Pharmacist is responsible for refusing to fill rx if he/she believes it was not issued for legit medical purpose, issued outside of valid patient/prescriber relationship or outside of the scope of the prescriber Transferring prescriptions/drug order information between pharmacies by a authorized personnel ○ Unfilled C2 that was issued electronically may be forwarded/transferred electronically only cannot do this for hard copy prescriptions, nor for faxed prescriptions ○ C3,4,5 can be transferred 1 time only but pharmacist sharing real time online databases (chains) may transfer up to the maximum refills permitted by law and the prescribers authorization (the number of authorized fills/refills) Transfers must be completed by end of next business day from the request Prospective drug utilization reviews ○ Requirements for reporting to PMP and accessing PMP data CS information must be submitted to PMP by pharmacy within 72 hours of dispensing Gabapentin and naloxone are also required to be reported to PMP This info is highly confidential and patients cannot see their own info from the pharmacy only by requesting the board. Not required to check PMP or if patient is  in hospice/palliative care or in a facility (hospital, nursing care ect) Delegate (intern/tech) may access PMP but must have their own login not shared login info Must inform patients about requirements to report rx info to PMP Exceptions to dispensing or refilling prescriptions/drug orders ○ Providers may issue a verbal C2 prescription in a true emergency. In this case quantity may not exceed # needed for emergency period, written rx must be delivered to pharmacy within 7 days ○ EPT RX: no provider relationship required. Rx doesn't need pt name, RX expired 30 days Patient or partner can fill rx Labeling of dispensed drugs ○ Label requirements: name & address of pharmacy, date of filling, name of pt, name of prescriber, directions, rx number. Drug name quantity, strength (unless prescriber request these to be omitted) ○ If substitution was made (brand - generic) label must sat generic name for [brand] Packaging of dispensed drugs ○ Customized adherence medication package (CAMP): drugs may be placed in same “well” (individual bubble pouch) as long as all drugs there are compatible with each other, are distinguishable from each other, and none require dispensing in original container ○ Med-pack may be used with patients consent: serial number is required for each drug therein and a serial  number for the pack itself, beyond use date of the pack is 60 days. ○ Any repackaged drugs in the hospital pharmacy must be labeled with manufacturer and lot number ○ Must use a safety closure container (child proof) unless pt requests not to. Patient must sign release for the use of non-saftey containers Drug product conditions prohibiting dispensing ○ In general adulteration refers to purity quality or strength of the drug being inappropriate misbranding refers to misleading labeling or a label lacking required information ○ Any drugs damaged (or even potentially damaged) by water, fire or other causes shall not be dispensed. Never dispense expired drugs these should be removed from inventory area ○ Shouldn't have drug samples in a retail pharmacy. Sometimes hospitals may have samples for practitioners to dispense directly to patients but this requires a physician to place he order in writing for themselves not for the pharmacist to dispense Requirements for the distribution and/or dispensing of non-prescrption pharmaceutical products, including controlled substances and hazardous drugs ○ Dispensing or administration If pharmacy lacks enough C2 remainder must be filled within 72 hours of partial fill As long as rx isnt expired ( or going to expire in 72 hours) C2 can be partially filled for up to 30 days per patient request (or prescriber request) C2 for patient in LTCF or terminal illnesses may be partially filled for up to 60 days ○ Labeling or non-prescription drugs and devices OTC drug must be labeled with: active ingredients, amount of active ingredients in each dosage unit, the purpose of the product, specific warnings including when to contact a doctor, possible AE, directions for use, lot number, pregnancy, breast feeding warnings, “questions? Call __” and inactive ingredients Dietary supplements may be marked with 3 types of claims: health claims, structure/function claims, and nutrient content claims. Cannot claim to treat, prevent or alleviate symptoms. FDA does not approve these ○ Packaging and repackaging of non prescription drugs and behind the counter products Repackaged OTC drug products are not exempt from FD&C act related to drug production Must be repackaged, stores and labeled in accordance w FDA approved labeling Any repackaging of OTC drugs should be done with caution taking into account the expiration date and other special features (storage conditions, tamper resistance ect) that are labeled on the OTC medication If packaging an OTC med for dispensing pursuant to a prescription it then must be labeled with directions from the prescribers prescription which override the OTC product labeling ○ Dispensing restricted, non-prescription drugs: pseudoephedrine max limit without prescriptions: 3.6 g in 24 hours. 9 g in 30 days. Must verify photo id, and patient must be > 18 years old. Must obtain signature of purchaser  Valid prescription cancels out all limits, can fill whatever amount prescriber says Pharmacy must post a sign in conspicuous are to inform persons of the methamphetamine offender registry act and keep the drug behind the counter Dextromethorphan without rx must be > 18 years old Ordering acquisition and distribution of drugs including maintenance and content of such records ○ Must keep records for 3 years, all prescription records (this includes transfers in/out) all MTM documentation, CS inventory records, pt profiles & drug orders (invoices) Paper CS prescriptions must be kept 3 years but non-cs paper rx must be kept 120 days then can store electronically only ○ Must keep immunization training records for 6 years minimum ○ Must keep clinical pharmacy records for no less than 7 years ○ Must keep all records onsite for 12 months then can move offsite ○ Distribution including the maintenance and content of such records Prescription files must be kept in 3 separate files, readily retrievable C2 apart from C3,4,5 apart from non-CS Recordkeeping in compliance with legal requirements, including content, inventory, maintenance, storage, handling and reporting ○ Non-dispensing requirements for operations of pharmacies or practice settings Must have effective controls against the diversion of drugs in place through written and established  policies, electronic alarm and video systems is required to be in place ○ Possession, storage and handling of non-hazardous drugs Hospitals that use automated distribution cabinets must allow pharmacist to verify drug before stocking, be monitored for accuracy of withdrawal procedure by all hospital staff, ensure that a blind count is made of CS when loading/removing CS Emergency kits must be verified by pharmacist, secured with tamper evident system labeled with all drugs therin. Use in emergencies only may contain CS Exp date of kit is earliest exp date of any drug therein, pharmacist must be notified when kit has been opened/used Contents are property of pharmacy, should only be accessed by nurse ○ Training possession, handling, storage and disposal of hazardous drugs See compounding study guide Oregon has a law that specifies flavoring rx drug is not considered compounding which is contrary to USP standards ○ Allowing non-pharmacist personnel access to drugs Hospital pharmacy must be secured from unauthorized access when open & closed, but chief pharmacy officer (PIC) may designate 1 specific nurse per shift to have access to pharmacy when it is closed, the nurse may remove a drug pursuant to valid rx order, must leave copy of the order for the pharmacist to verify next day  Hospital pharmacy: night cabinets may be accessed by 1 nurse per shift, must leave med order for pharmacist review, audit of CS in cabinet must be conducted at least monthly, may only contain prepackaged drugs in quantities NTE immediate therapeutic needs If drug needed not in night cabinet 1 nurse may access pharmacy leaving med order for pharmacist to review ○ Requirements for conducting controlled substance inventories CS inventory must be taken annually, and records must be kept for at least 3 years CS inventory also must be taken within 15 days of a change of PIC C2 must be exact cout C2 inventory : perpetual for hospitals and quarterly for retail Hospitals must reconcile perpetual C2 w actual inventory monthly, quarterly random sampling Hospitals must inspect all areas containing drugs at least every 2 months, and recordkeeping requirements include verification any wasted drug including partials, delivered receipts of CS Theft of any med must be reported to the board within 1 day. If theft of CS must inform DEA within 1 day then complete DEA form 106 and submit to DEA within 45 days Delivery of drugs ○ FDA can rewuire a med guide to be dispensed with certain medications (REMS) in which this patient labeling could  prevent serious adverse events or the med has serious risks Conditions for permitted or mandated product selection ○ May select interchangeable biologic product if: FDA says equivalent, prescriber didn't indicate no substitution is allowed (“dispense as written”) Pharmacist must inform the patient of the substitution Prescriber must also be notified within 3 days of actual product dispensed FDA purple bool shows a list of licensed biologics for interchangeability Compounding sterile, nonsterile, hazardous and non-hazardous preparation ○ See study guide Centralized prescription processing or central fill pharmacy dispensing ○ Must either have shared ownership or a contract in place that outlines responsibilities ○ Central fill pharmacies must share patient profiles electronically with home pharmacy, identify who responsible for each step in the filling process and ensure adequate security measures protect patient info. Can do CS and non-CS for initial and/or refill prescriptions, ○ Pharmacist at either location may do DUR which is required. CF pharmacy may ship meds to pt directly. Patient must be notified of use of central fill Requirements for registration, licensure, certification or permitting of a practice setting/business entity ○ Req for registration, license, cert, permit Pharmacy registration expires march 31 annually  Pharmacist must always be present must always be present when pharmacy open. Only pharmacist can open for the day Report any disaster/accident/emergency that may affect purity of drugs to the board immediately Permanently closing pharmacy: notify pts 15 days prior, conduct inventory, notify DEA where CS will be transferred to Update board 15 days in advance of change in pharmacy ownership or location telework is prescription processing. telework site must be inspected every 6 months. No drugs or devices may be stored at a telework site. Pharmacist must offer/provide counseling ○ Req for renewal or reinstatement of a license, registration, certificate or permit of a practice setting Pharmacy must be registered w DEA to maintain stock of CS and dispense CS This registration may be revoked if convicted of drug related offense Closing a pharmacy: must take final CS inventory and inform board plan for disposition of pharmacy records and prescription drugs. Return pharmacy license and CS registration Remote processing: both pharmacies have PIC, separate licenses, perform DUR, CS are okay, document each step ○ Requirements for inspection of a licensed, registration, certified, or permitted setting All aspects of a pharmacy are subject to inspection, pharmacist cannot refuse to allow entry  May occur at any hours open for business. May take photos/videos/recording Self inspection is required by july 1 If change in PIC self inspection of the pharmacy is required within 15 days Any discrepancies must be corrected and/or addressed with board ○ Classification and processing of disciplinary actions that may be taken against a registered, licensed, certified or permitted practice setting Pharmacy license may be suspended/revoked/not renewed for breaking basically any rules Federal Registration requirements ○ Every pharmacy that dispenses CS must be registered with DEA through form 224, Registration must be renewed q 3 years. If person owns more than 1 pharmacy each place must be separately registered ○ Federal law prohibits the handling of CS for any period of time under an expired registration ○ A pharmacy that plans to transfer its business operations must submit information regarding the transfer to the DEA at least 14 days in advance. On the date of the transfer of business a complete inventory must be taken to document the drug name, dosage form, drug strenth, quantitiy and data transfer. This inventory record serves as the official inventory for the pharmacy acquiring the controlled substances and the pharmacy must keep record for at least 2 years Transferring C2 to another pharmacy requires form 222 or electronic equivalent  Ordering controlled substances ○ DEA form 222 is now solely a single sheet (the old triplicate form has been discontinued) for ordering C2 drugs which may also be done electronically through the controlled substance ordering system (CSOC) CSOS is the only electronic means of ordering c2 drugs (can also be used to order C3,4,5) ○ When items are received, purchaser (pharmacy) must document the actuarial number of items received & the date Must keep receipt (invoice, packaging slip) of the date and confirmation that the order is accurate ○ 222 forms and records or CSC orders must be maintained separately from all other records, kept for 2 years ○ Pharmacy must immediately report loss/theft of DEA form 222 to a DEA officer with a serial number of each form Inventory requirements ○ CS inventory records must be maintained for at least 2 years ○ Inventories of C2 drugs must be kept determined by the actual physical count Inventory records of C2 drugs must be kept separately from C3,4,5 which also must be separate/distinguishable from other drug (non-CS) inventory records ○ For inventory of C3,4,5 the pharmacy may make an estimated count on open bottles that contains < 1,0000 tabs/caps, but exact count is required for bottles with > 1000 tab/cap ○ An inventory of all controlled substances must be taken upon issuance of a DEA registration, and a record must be made showing zero inventory  ○ After initial inventory the registrant is required to take a new inventory at least every 2 years if a drug not previously scheduled becomes listed as a CS inventory must be taken of that drug on the date of scheduling Recordkeeping requirements ○ All records concerning CS must be maintained for at least 2 years, shipping and financial records may be kept at a central location ( not at pharmacy) if the pharmacy submits written notification to DEA field office. Records and inventories of schedule 2 CS must be kept separately from all other records of the registrant. All records and inventories of schedules 3,4,5 CS must be kept either separately from all other records or in a way that the information requires is readily retrievable from ordinary business records Valid prescription requirements (outpatient prescriptions, not inpatient medication orders) ○ Prescriptions for for a CS must be dated on the date issued ( even if there is a different “ do not fill until date”) the RX must contain patients fill name, address and prescribers name address and DEA # ○ RX for CS may be issued by a physician, dentist, podiatrist, veterinarian, mid level practitioner who is Authorized to prescribe controlled substance by their licensed jurisdiction and Registered with DEA or exempt from registration, or An agent/employee of a hospital under the registration of the hospital which is registered with DEA ○ A prescription may not be issued in order for an individual practitioner to obtain CS for supplying the individual practitioner for the purpose of general dispensing to pt ○ To be valid, a prescription for a CS must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by DEA regulations An order purporting to be a prescription that is not issued for a legitimate medical purpose in the usual course of professional treatment or in a legitimate and authorized research is an invalid prescription. The person knowingly filling such a prescription as well as the person issuing it shall be subject to penalties provided for violations of provisions of law related to CS The law does not require pharmacists to dispense a rx of doubtful, questionable or suspicious medical legitimacy. To the contrary the pharmacist who deliberately ignores the high probability that a rx was not issued for a legitimate medical purpose and fills the rx may be prosecuted along with the prescriber for knowingly and intentionally distributing CS ○ Practitioners who are agents or employees of a hospital or other institute may administer or dispense or prescribe CS under the registration of the hospital or other institution in which he or she is employed in the lieu of individual registration, pharmacist should contact the hospital or other institution for verification if they have any doubt in filling prescriptions issued under the hospital DEA registration ○ For electronic prescriptions written by mid level practitioners if required by state law it is DEA policy that a supervisors name and DEA number be listed on the prescription provided the prescription clearly indicated which is the supervisor and the prescribing practitioner ○ There is no federal time limit within which a schedule 2 rx must be filled after being signed by the practitioner, however the pharmacist must determine that the prescription is still needed by the pt and the amount dispensed must be consistent with the requirement that a rx for a CS be issued only for a legitimate medical purpose by a practitioner actingin in the usual course of practice Though there is no express federal limits with respect to quantities of drugs dispensed via a rx, to be valid, a rx for CS must only be for legitimate medical purposes by a practitioner acting in the usual course of professional practice ○ Refilling of a rx for a C2 is prohibited but a prescriber may issue multiple C2 rx authorizing the patient to receive a total of up to 90 ds of a C2 provided the following are met: Each separate rx must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice The individual practitioner must provide written instructions on each prescription (other than the first rx, if the prescribing practitioner intends for that prescription to be filled immediately), indicating the earliest date on which a pharmacy may fill each rx The individual practitioner concludes that providing the pt with multiple rx in this manner does not create an undue risk of diversion or abuse The issuance of multiple prescriptions is permissible under applicable state laws The prescriber complies fully with all other applicable requirements under the CSA, CFR and state law ○ In general RX for C2 may not be faxed for pharmacies but faxing a C2 may be okay & serve as original rx if  Practitioners prescribing a schedule 2 narcotic CS to be compounded for the direct administration to a pt by parenteral, IV, IM, SC or intraspinal infusion may transmit the prescription by fax. The fax serves as a original written rx and no further documentation is needed. All normal requirements of legal rx must be followed Practitioners prescribing schedule 2 CS for residence in LTCF or have an agent transmit and rx to dispensing pharmacy by fax. The fax rx served as the original rx not further documentation needed A practitioner prescribing a C2 narcotic substance for a pt enrolled in a hospice care program certified and/or paid for my medicare of a state licensed hospice program may transmit a rx to the dispensing pharmacy by fax. The practitioner will not be on the rx that it is for a hospice patient. The fax serves as the original prescription no further documentation needed ○ In august 2023 DEA now ALLOWS electronic CS prescriptions to be transferred electronically 1 time only to another pharmacy in this case C2 can be transferred prior to 1st (only) fill as long as it is electronically ○ Schedule 3 and 4 CS may be refilled if authorized on the prescription however the rx may only be filled up to 5 times within 6 months after the date issued. After 5 refills or after 6 months, whichever occurs first, a new rx is required. A pharmacist may dispense a controlled substance listed in scheduled 3,4,5 pursuant to an oral prescription (unless state law mandated electronic prescribing for all CS), made by an individual practitioner & communicated by the practitioner or their authorizing agent and promptly reduced  to written by the pharmacist containing all information required for a valid rx except for signature of practitioner ○ Pharmacy may transfer original rx info for C3,4,5 to another DEA registered pharmacy for the purpose of refill dispensing between pharmacies on a one time basis only. Cannot transfer of any original unfilled rx received in paper (including fax) or oral form to another pharmacy; however after original rx is filled, refills may be transferred. In august 2023 DEA amended stance to now allow electronic prescriptions to be transferred electronically 1 time only to another pharmacy. In this has, can be transferred prior to 1st fill. Any applicable refills must also be transferred all together with the transfer meaning the rest of the RX must be filled at the 2nd pharmacy ○ Transfers for CS must be communicated directly between two licensed pharmacists Dispensing requirements ○ Is it required that the label of CS in schedules 2,3,5 contain “CAUTION: federal law prohibits transfer of this drug to any person other than the pt for whom it was prescribed” ○ A prescription for a C2 may be partially dispensed if the pharmacist is unable to supply the full quantity of the written or emergency oral (phone) prescription, provided that the pharmacist noted the quantity supplied The remaining portion may be dispensed within 72 hours of the first partial dispensing, however if the remaining portion is not or cannot be filled within 72 hours without a new rx the pharmacist must notify the prescriber. No further quantity may be supplied beyond 72 hours without a new rx. It is the position of DEA that the pharmacy must have the balance of the  rx ready for diapening prior to the 72 hour limit, but the pt is not requires to pick up the balance of the rx within that 72 hour limit ○ A prescription for a C2 may be partially filled at the request of the patient or the prescribing practitioner if Partial filling is not prohibited by state law Rx is written and filled in accordance with CSA, DEA regulations and state law Total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and The remaining portions of a partially filled rx in schedule 2 if filled shall be filled no later tha 30 days after the date on which rx was written ○ A prescription for a C2 written for a pt in a LTCF for a pt with a medical dx documenting a terminal illness may be filled in partial quantities to include indivuidual dosage units The pharmacist must record on the rx whether the patient is “terminally ill” or “LTCF pt” C2 prescriptions for pts in an LTCF or terminally ill pt are valid for a period not to exceed 60 days from the issue date unless sooner terminated by discontinuance of med ○ Pharmacist may partially dispense a rx for CS in schedules 3-5 provided that each partial filling is recorded in the same manner as a refilling, the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed and no dispensing occurs beyond 6 months from the date of issuance ○ An emergency situation means prescriber has determined that immediate administration of the drug is necessary for the patient and no appropriate alternative tx is available (including a drug which is not a C2), and it's not reasonably possible for prescriber to provide a written rx for the drug at that time. In an emergency a prescriber may phone a C2 prescription (provided orally, not written) to a pharmacist who may then dispense. Prescriber must provide written & signed rx to pharmacy within 7 days and meet the below requirements: The drug must be limited to the amount needed to tx the patient during the emergency period Pharmacist must immediately reduce rx to written with all required info except prescriber signature If prescribing individual practitioner is not known to the pharmacist he or she must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner Within 7 days after authorizing an emergency oral rx, the prescribing practitioner must furnish the pharmacist a written, signed rx for the emergency quantity of a CS prescribed, the prescription must have written on its face “authorization for emergency dispensing” and the date of the oral order, the written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail, it must be postmarked within the 7 day period The pharmacist must attach the written rx to the oral emergency rx form before By regulation the pharmacist must notify the local DEA diversion field office if the prescriber fails to provide written rx within 7 days, failure of the pharmacist to do so will void authority conferred in the pharmacy to dispense the CS without a written prescription of a prescribing practitioner  For electronic rx the pharmacist must annotate the record of the electronic rx with the original authorization date of the oral order Security requirements ○ The theft of CS from a registrant is a criminal act and a source of diversion that requires notification to DEA. A pharmacy must notify in writing the local DEA diversion field office within 1 business day of discovery of a theft or significant loss of a CS. the DEA form 106 is used to document the actual circumstances of the theft or significant loss and the quantities of CS involved ○ Breakage or spillage of CS must be recorded on DEA form 41 and signed by 2 individuals that can testify this occurred Transfer or disposal of CS ○ Records involving transfer of CS to another pharmacy or to supplier/manufacturer must be kept for 2 years ○ To transfer C2 drugs the receiving pharmacy must issue DEA form 222 or electronic equivalent to the pharmacy transferring the drugs ○ If a pharmacy goes out of business or is acquired, it may transfer controlled substance to another pharmacy ○ On day CS are transferred an inventory must be taken which documents the drug name, dosage form, drug strength, quantity & date transferred. DEA form 222 or electronic equivalent must be documented ○ Pharmacy may transfer CS to DEA registered reverse distributor who handles the disposal  ○ All CS to be destroyed by a registrant or caused to be destroyed by a registrant shall be destroyed in compliance with applicable federal, state, tribal, and local laws and regulations and shall be rendered non-retrievable. A pharmacy registrant may dispose of its CS inventory in the following manner: Promptly destroy that CS using an on-site method of destruction Promptly deliver ( or allow pickup) that CS to a reverse distributor For the purpose of return or recall, promptly deliver that CS to: the registered person from whom it was obtained, the registered manufacturer of the substance or another authorized registrant Request assistance from a special agent in charge of the administration in the practitioners area Authorized collectors ○ Authorized collectors may receive a CS for the purpose of destruction from an ultimate user, a person lawfully entitled to dispose of an ultimate user decedent's property, or an LTCF on behalf of an ultimate user who resides or has resided at that facility. Retail pharmacies and hospitals/clinics with onsite pharmacies may modify their registrations to obtain authorization to be a collector. Once authorized such entities are “authorized collectors”. ○ Only CS that are lawfully possessed by an ultimate user or other authorized non-registrant person may be collected. Controlled and noncontrolled substance may be collected together and be comingled, although comingling is not required ○ Authorized collectors shall only allow ultimate users and other authorized non-registrant persons in lawful  possession of a CS to deposit such substances in a collection receptacle at a registered location. Once a substance has been deposited into a collection receptacle the substances shall not be counted sorted inventories or otherwise individually handled Other pharmacy operations ○ Central fill (CF) pharmacies are permitted to prepare both initial and refill rx as long as contract is in place or have a common owner with the retail pharmacy. Both the retail and CF pharmacies have a corresponding responsibility to ensure that the rx was issued for a legitimate medical purpose by a practitioner actingin in the usual course of practice, CF pharmacies must affix to the package label showing the retail pharmacy name, address and unique identifier (ex DEA registration number indicating the rx was filled at the CF location). Both pharmacies must keep records ○ Authorized dispensing systems (ADS) means a mechanical system that may store, package, count, label, and dispense medications and maintains all transaction information. A retail pharmacy may register at the site of a LTCF and store CS in an ADS. in an ADE a pharmacy stores bulk drugs in the machine in separate bins or containers, and the pharmacy programs and controls the ADS remotely, authorized LTCF staff are allowed access to its contents which are dispersed on a single dose basis at the time of administration pursuant to a valid rx. The ADS electronically records each dispensing this maintaining dispensing records for the pharmacy. Because drugs are not considered dispensed until the system provides them the drugs in ADS are counted as pharmacy stock. ○ All emergency kits are for emergency use only. And CS may be dispensed for emergency purposes pursuant to a valid rx/order. Thus where the kit is maintained at the LTCF by a pharmacy, CS may not be dispensed from the kit for emergencies prior to receipt by the pharmacist of a valid rx. E kits require DEA registration. May contain all schedules of CS ○ Patients may bring CS from home to hospital for their hospitalization stay as long as treating practitioner deems that it medically appropriate for pt to continue to take, if so, CS brought from pt home to hospital may be secured in a hospital room (small safe or lock box), if the treating practitioner deems it medically inappropriate for pt to continue taking any CS from pt residence to hospital then the hospital may turn over the drugs to a patient's family member, dispose of the drugs, utilize mail-back packaging ect ○ A registered pharmacy may distribute CS (without being registered as a distributor) to another pharmacy as long as the total number of dosage units in all CS distributed by pharmacy does not exceed 5% of the total number of dosage units of all CS dispensed by pharmacy during the calender year If at any time during the calender year the total number of dosage units of CS distributed exceeds 5% of the total number of dosage units of CS distributed and dispensed the pharmacy is requires to register as a distributor ○ Pharmacies may mail CS through US postal service according to the following: The inner packaging of any parcel containing CSC is marked and sealed as required by the provisions of  the CS act and is placed in a plain outer container or securely wrapped in pain paper If the CS consists of a rx medication the inner container is also labeled to show the name and address of the pharmacy, practitioner or other person dispensing the rx Outside wrapper or packaging is free of markings that would indicate the nature of the contents Combat methamphetamine epidemic act 2005 ○ Requirements for drugs such as pseudoephedrine (without rx) through retail sales include: The drug be kept behind the counter or in locked cabinets Sellers check the identity of the purchaser and maintain a log of each sale Maintain a log book (can be electronic) for at least 2 years Train employees on these requirements of law Single day quantity limit is 3.6 (state law may vary) Packaging is limited to bister packs containing no more than 2 doses/unit per blister pack Record keeping Name and address of purchaser, date and time of sale, name a amt sold Purchasers are required to Present gov issued photo ID Sign logbook (written or electronic)  Appendix D ○ Pharmacies have a personal responsibility to protect their practice from becoming an easy target for drug diversion. They need to know of the potential situations where drug diversion can occur and establish safeguards to prevent drug diversion ○ The dispensing pharmacist must maintain constant vigilance against forged or altered rx. The CSA holds the pharmacist responsible for knowingly dispensing a  prescription that was not issued in a usual course of professional treatment ○ Identifying out of scope rx The following criteria may indicate that a rx was not issued for a legitimate medical purpose Prescriber writes significantly more tx (or larger quantities) compared to other practitioners in the same specialty area The patient appears to be returning too frequently. A rx which should last for a month in legitimate use is being refilled on a biweekly, weekly or even daily basis Prescriber writes prescriptions for antagonistic drugs (depressants & stimulants) at the same time The patient presents prescriptions written in the names of other people A number of people appear within a short tome all bearing similar rx from the same prescriber People who are not regulars show up with a prescription from the same prescriber ○ The following criteria indicate a forged rx Prescription looks “too good” the prescribers handwriting is too legible quantities , directions, doses differ from usual medical use Rx does not comply with acceptable abbreviations or appears textbook presentation Rx appears to be photocopies Directions are written in full with no abbreviations Rx is written in different color inks or written in different handwriting  ○ If at any time a pharmacist is in doubt they should require proper identification. Although this procedure is not foolproof (identification papers can also be stolen/forged). It does increase the risk to the individual trying to fill fraudulent rx. If a pharmacist believes they have discovered a pattern of rx abuse they should contact BOP or local DEA diversion field office Appendix H (guidelines for e-kits in LTCF) ○ A pharmacy may place a e-kit with CS in a non-DEA registered LTCF if: Source from which LTCF may obtain CS for e kits and that the souce supply is a DEA registered hospital/clinic pharmacy or practitioner The security safeguards for each emergency kit stored at the LTCF including who may have access to the e kit and specific limitation of the type and quantity of CS permitted in kit Responsibility for proper control and accountability of e kit within LTCF including the req that the LTCF and supplying registrant maintain complete and accurate records of the CS placed in the ekit, the disposition of the CS and to take and maintain periodic physical interventions The emergency medical conditions under which the CS may be administered ti LTCF pt including the req that CS ba administered by authorized personnel only as expressly authroized by individual practitioner The prohibited activities that if violated could result in state revocation, denial, suspension of privilege to supply or possess emergency kits containing CS DEA forms ○ 106: to report theft or significant loss of CS  ○ 41: to report CS destruction ○ 222: order/transfer C2 ○ 224 for a pharmacy’s registration w DEA to be authorized to obtain and dispense CS Risk evaluation mitigation strategy (REMS) ○ REMS is focused on preventing, monitoring, managing a serious risk by education and/or reinforcing actions to reduce the severity of a event - it is not designated to mitigate all AE Different drugs have different REMS req ○ In order to dispense a REMS drug the pharmacist may be required to be certified in that specific REMS. patient may be required to document monthly lab test before pharmacist is authorized to dispense drug Pharmacist may need extra training, drug may be subject to day supply limit ○ REMS may necessitate manufacturer to create “med guides” which contain FDA approved information, are apart of the drug labeling and are provided to pt at time of dispensing HIPPA and privacy ○ Notice of privacy practices Must be provided to anyone who asks for it Must be made available on a pharmacy’s website May be emailed to pt if pt has agreed to receive it through email ○ Privacy practices must contain : how pharmacy will use/disclose the PHI, the individuals rights, effective date of the notice, who the person may contact for more information, the pharmacies legal duty with respect to law  ○ Breach: impermissible use or disclosure that compromises the privacy of persons PHI; NOT a breach: the low probability that PHI has been compromised, person to whom the impermissible disclosure was made would not have been able to retain the info or disclose to another HC professional Following breach pharmacy must notify affected individual (s) within 60 days. May have to notify HHS ○ Pharmacy should make good faith effort to obtain patients acknowledgement of receipt of the notice but not absolutely required to obtain this is extenuating circumstances Drug recalls ○ Recall may be conducted by a pharmacies own initiative or pursuant to FDA request Recall may require that the pharmacy notifies patients taking the drug Class 1: dangerous/defective product that could cause serious problems/death Class 2: product may cause temp health prob or post slight threat of a serious nature Class 3: unlikely to cause any adverse health reaction bur violates FDA labeling/manufacturing Vaccines VIS & VEARS ○ VEARS is a national vaccine safety surveillance program that helps detect unusual or unexpected AE related to vaccines. VEARS accepts reports from anyone (HC pro or pt), makes all data publicly available, and it is required of HC professionals to report to it when necessary ○ VIS: required to be given to pt prior to vaccine being administered and must document: edition date of the VIS, date VID is provided, name/title of person administering, manufacturer & lot #  ○ VIS must be offered to pt to take away with them & must be provided to pts parent/guardian if a minor Compounding General overview ○ All facilities (pharmacies) must have a designated person qualified & trained to be responsible for implementing appropriate compounding procedures, which applies for non-sterile, sterile and hazardous, and it could be the same person for all 3 if the facility performs all 3. The facility may also designate more than one designated person (for example there are 2 people for sterile) and it does not have to be a pharmacist ○ Compounding does not include mixing, reconstituting or other acts performed in accordance with the directions in the approved labeling or supplemental material provided by the products manufacturer If adding flavor which is outside of approved labeling that is considered compounding ○ In general preparations designated to be delivered to a body part that does not have contact with the environment outside of the body such as bladder cavity or peritoneal cavity are required to be sterile Ophthalmic products and compounded aq inhalation solutions and suspensions are required to be sterile Otic preparations are not required to be sterile unless being administered to a patient with a perforated eardrum, irrigations for the mouth, rectal cavity and sinus cavity are not required to be sterile nor are nasal sprays ○ Hazardous drug compounding can be sterile or non-sterile  ○ Pharmacies are prohibited from compounding products that are commercially available or essentially a copy of a commercially available product however a pharmacy may compound a very similar but slightly different product that the prescriber prescribes if it: Would product give a significant difference in the pt care compared to commercial product Is necessary bc of change in dosage form, strength, or omit component to which pt has a allergy ○ In general pharmacies should use components/substance in compliance with USP or national formulary monographs if one exists for that substance. If not may use components from an FDA approved drug. If no such drug exist use FDA list of bulk drug stabstanced for use in compounding ○ Compounded drugs prepared by pharmacies are not FDA approve and thus not subject to CGMP requirements (current good manufacturing practices) ○ Antibiotics, cytotoxic drugs or hazardous materials call for pharmacy use special equipment dedicated specifically for that one product or disposable equipment Nonsterile products ○ Personnel grabbing, training All personnel who compound or have direct oversight of compounding must be initially trained and qualified by demonstrating knowledge and competency according to requirements knowledge and competency must be demonstrated initially and at ever 12 months Training must include understanding requirements of chapter 795 , understand and interpret safety data sheets, understand procedures related to compounding duties  This training must be documented in the pharmacy Must re-evaluate employee(s) annually Gloves are required to be worn when compounding products, change or wipe gloves before new compounding Other grabbing such as hair covers or gowns are suggested and may be required by individual pharmacies procedures. Gowns may be reused if they are not torn, punctured or soiled Can re-use gowns if not soiled/torn Cleaning should occur before initiating compounding each time. Temp in storage areas should be monitored daily Knowledge and competency must be demonstrated initially and every 12 months for those that clean/sanitize. Containers used must not alter the quality, strength, purity of the compounded drug preparation. Must be stored off the floor and stored in a way that prevents contamination. Should use the oldest stock first ○ Procedures Non-sterile compounding is not required to take place in a separate room but should have its own designated area no more than 1 preparation may be compounded at a time in that specific workspace This non-sterile workspace must be separate and distinct from the sterile workspace is there is one A master formula record must be created before a new preparation is compounded in a pharmacy for the  first time. Then, a compounding record must be completed each time a preparation occurs Different quantities (120g vs 60 g) of the same product can use can use the same master formula but the compounding record will be different in this care Master formula must include ○ name/strength/dosage form of the preparation, calculations needed for determining quantities, compatibility/stability information, mixing instructions , sample labeling ingo such as BUD guidelines and storage conditions, the container for dispensing, description of final preparation Compounding records must include: ○ name/strength/dosage of the preparation, MFR used for reference, info of components used (sources, lot numbers, exp dates), total quantity compounded, name of person who prepared product, name of person who preformed quality control, date of preparation, prescription number, assigned BUD (specific date), documentation of any issued reported by pt Any deviation from the standard compounding process must be documented ○ When a compound calls for water use purified water or sterile water or irrigation Distilled water may be used only if it “meets the requirements of purified water”  ○ The label should include BUD and a statement that “ this is a compounded preparation” ○ BUD is determined by the date of preparation, not the date that the pt first uses it Term “ water containing” has been eliminated from use as it related to determining BUD Water “activity levels” (Aw) are used to determine BUD Compounded sterile products ○ Personal & training Standard operating procedures (SOPs) written by the pharmacy/facility are required to be made and maintained. Must address training requirements for compounders, selection of components, BUD and labeling and initial ongoing training is required of those that enter clean room only for cleaning/restocking Any person entering a sterile compounding area whether preparing a CSP or not must meet grabbing reqs. Personnel who do not compound not have direct oversight of compounders but do other taste such as cleaning/disinfecting the compounding area ot restocking items may need to be trained per facilities SOPs  Personnel that prepare sterile products required to undergo training initially and media filling testing of aseptic skills Every 6 months for compounders of category 1 and 2 Every 3 months for compounders of category 3 Those who have direct oversight of compounders at least every 12 months Personnel involved in immediate use compounding must be training and demonstrate competency in aseptic process as they relate to assigned tasks and the facilities SOPs Personnel who only prepart immediate use CSPs are not required to preform medial fill testing but the facility SOPs must determine how their competency will be evaluated ○ Garbing When performing sterile compounding a person must remove wedding rings, eyelash extensions, food, gum and mints. An adhesive bandage / covering may be appropriate to cover jewelry that cannot be removed Garbing competency evaluations include visual observation and gloved fingertip and thumb sampling of both hands. Compounders and those who have direct oversight of compounders must complete initial garbing competence evaluation no fewer than 3 separate times. The successful completions must be in succession Failure of any of the 3 initial garbing competence evaluations requires repeat testing until personnel successfully completes 3 evaluations in a row  Ongoing grabbing competency evaluations as well as ongoing aseptic manipulation competency evaluations Must be performed every 6 months for compounders of cat 1 and 2 preparations Must be performed every 3 months for compounders of cat 3 preparations Those who have direct oversight of compounders must complete this at least q 12 months Order of garbing must be determined by the facilities SOP. sterile gloves must be donned in a classified room or SCA. hand dryers must not be used. Disposable soap containers must be replaced not refilled Apply 70% IPA to gloves immediately before compounding and regularly throughout the process Cat 1&2 compounding : gowns may be reused within same shift by the same person if the gown is maintained in classified area or adjacent / within segregated cmpd area, in way that prevents contamination Other garb may not be reused must discard Cat 3 compounding grabbing requirements must be continuously met in the buffer room & cmpd area No exposed skin; face & neck must be covered All low lint outer garb must be sterile Disposable garb cannot be reused. Laundered garb (certain gowns) must not be reused without being laundered and resterilized  Facilities SOPs must describe disinfection procedures for reusing goggles, respirators and other reusable equipment Sterile compounding basics ○ Docking a proprietary bag and vial system for immediate use is not considered compounding Docking for future use is considered compounding and must be performed in ISO class 5 environment ○ CSPs can be compounded using only sterile ingredients OR also using some nonsterile ingredients as long as sterility of the end product is achieved through sterilization process ○ Administration of compounded sterile products cannot begin past the BUD/time. However if administration or infusion has already begun and later it reaches the BUD/time administration of this product can continue ○ A single dose container may only be used for 1 pt regardless of whether or not it is immediate use May be used within 12 hours of opened in ISO class 5 air as long as the labeled storage requirements during the 12 hour period are maintained. Single dose ampules may not be stored. ○ After initially entering/opening a multiple dose container (vial) it has a BUD of 28 days unless otherwise specified by manufacturer ○ CSPs must contain an amount of active ingredient that (slightly) exceeds the monograph limits (if a monograph exists) ir is within 10% of the intended active ingredient amount if no monograph exists ○ If a water containing compounded sterile product is non sterile during any phase of the compounded procedure it  must be sterilized within 6 hours of completion of the preparation ○ Packaged and labeled CSPs should be visually inspected for physical integrity and expected appearance including the final fill amount Sterile compounding categories ○ CSP are not categorized into “immediate use” and cat 1,2,3 The old low/medium/high classification is not obsolete, although may still be found in state law The categories correspond to the condition under which the CSPs must be prepared ○ Immediate use CSPs are exempt from some requirements such as garbing and ISO 5 air, as long as: No more than 3 different sterile product (ingredients) Administration begins within 4 hours of the start of preparation Immediate use CPs may not be stored of any period of time and may not be prepared in advance ○ Category 1 Must be prepared in a PEC that may be located in an unclassified segregated compounding area. Assigned a BUD of < 12 hours at controlled room temp or < 24 hours when refrigerated ○ Category 2: must be prepared in a clean room suite May be assigned a BID of > 12 hours at controlled room temp or > 24 hours if refrigerated ○ Category 3: have additional requirements that must be met at all times May be assigned a BUD longer than BUDs established for Cat 2 CSPs up to 180 days  Sterile compounding procedures ○ The primary engineering control (PEC) provides ISO class air 5. This device is usually a laminar airflow workstation (LAFW) or compounding aseptic containment isolator (CCACI) or may be a BSC or CAI. the compounding process occurs within PEC to maintain sterility through its HEPA filtered unidirectional airflow. PEC itself is placed in buffer area which provides ISO class 7 air throughout the room. The ante area is either ISO class 7 / 8 air and the room is where garbing/handwashing occurs so ante area may have a sink ○ In addition the primary engineering control (or hood) must be an ISO class 5 environment or better. The positive pressure buffer area must be an ISO class 7 env or better the positive pressure ante rooms must be an ISO class 8 env or better ○ The PEC must be cleaned at the beginning of each shift, before each match, and not longer than 30 min when compounding is ongoing. The floors and countertops (in the buffer and ante areas) should be cleaned daily whereas the calls, ceilings, storage shelving should be cleaned monthly ○ Cleaning supplies Must be low lint disposable or reusable tools must be dedicated for specific areas Cleaning, disinfecting and sporicidal agents used within PEC must be sterile. Sterile water must be used when diluting concentrated agents for use in the PEC ○ Master formulation records (MFR) must be created for all CSP prepared for more than 1 pt or when using non-sterile components. Any changes/alterations must be approved & documented based on facility SOP ○ “Compounding record” must be created for all categories Except for when an immediate use CPD is made for more than 1 pt, compounding record is required May be in the form of a prescription or medication order or label May be stored electronically as long as it is retrievable & contains the required information ○ Maximum batch size for all CSPs requiring sterility testing must be limited for 250 final yield units Number of CSPs needed to be sent for sterility testing depends on the number of CSPs to be compounded in the single batch ○ Sterility testing is required for category 3 May be required for category 2 based on the BUD. not required for category 1 preparations ○ Labeling on the dispensed CSP should indicate that the preparation is compounded ○ Factors that determine BUDs include storage conditions (controlled room temp, refrigerator ect) compounding  method, if sterility testing is performed, storage conditions ect ○ Non-preservative topical ophthalmic CSPs Requirement for antimicrobial effectiveness testing is not required if preparation is Prepared as a category 2 or 3 CSP For use by a single pt Labeled to indicate that once opened it must be discarded after 24 h stored at controlled room temp or 72 h in the fridge ○ Using compounded sterile products to compound additional compounded sterile products Multidose CSP after punctured may not be used longer than 28 days Single dose CSP may be used for up to 12 hours to make other sterile products ○ Notification and recall of CSPs with out of specification limits SOP must contain procedures for Determining severity of problem & urgency for implementation and completion of the recall To determine distribution of any affected CSP To identify pt who received the CSP For disposal and documentation or recalled CSP To investigate and document reasons for failure Hazardous drug compounding ○ Personnel & training Access to areas where HDs are handled must be restricted to authorized personnel All personnel who perform custodial waste removal and cleaning activities in HD handling areas must be trained in all appropriate procedures to protect  themselves and the environment to prevent HD contamination All personnel who handle HDs must be trained before handling HDs & reassessed at every 12 months with documentation, training must include: overview of HDs and risks SOPs related to handling of HSs proper use of PPE, use of equipment (engineering controls) response to HD exposure, sill management, disposal. Personnel of reproductive capability must confirm in writing that they understand the risk of handling HDs ○ Gowning and PPE Disposal PPE must not be re-used. Reusable PPE must be decontaminated and cleaned after use Gowns, head, hair, shoe covers and two pairs of chemotherapy gloves required for compounding sterile and nonsterile HDs. 2 pairs of chemo gloves required for administering injectable antineoplastic HDs Gowns shown to resist permeability of HDs are required when administering injectable antineoplastic HDs Appropriate PPE (per pharmacy SOP) must be worn when handling HDs during: receipt, storage, cleaning, transport, compounding (sterile & nonsterile), administration, deactivation, spill control. Waste disposal Gloves: chemotherapy gloves must be powder free, must be inspected for defects prior to use, do not use gloves with pin holes or weak spots, when used for sterile cmpd, the other chemotherapy gloves must be  sterile. Change chemotherapy gloves every 30 min and when torn, punctured or contaminated. Gowns: must be disposable and resist permeability by HDs. must close in the back (no open front), long sleeved and have closed cuffs. Cloth lab coats, surgical scrubs, isolation gowns are not appropriate Change gowns every 2-3 hours or immediately after a spill/splash. Gowns worn in HD handling areas must not be worn to other areas When compounding HDs second pair of shoe covers must be donned before entering, shoe covers worn in HD areas must noy be worn to other areas. Disposable sleeve covers mat be used to protect arms Goggles must be used for eye protection, eyeglasses or safety glasses with side shields do not protect eyes adequately from splashes. Face shields in combination with goggles provide full eye and face protection Respiratory: surgical masks must not be used. Surgical N95 respirator provider respiratory protection and barrier to splashes droplets sprays. For respiratory protection a NIOSH certified fit test N94 is sufficient. However N95 respiration offer no protection against gasses and little protection against direct liquid splashes Disposal of used PPE: place in appropriate waste container & further disposal per local, state, federal regulations. PPE worn during cmpd should be disposed in the proper container and chemotherapy gloves & sleeve covers worn during compounding  must be carefully discarded into approved waste container ○ Hazardous compounding procedures HDs must be unpacked in area that is neutral/normal or negative pressure relative to surrounding areas HDs must not be unpacked from shipping containers in sterile compd areas or in positive pressure areas HDs must be stored in way that prevents spillage/breakage if container falls, do not store of floor antineoplastic HDs requiring manipulation other than counting or repackaging of final dosage or repacking final dosage forms and HD API must be stored separately from non-HDs in a manner that prevents contamination and personnel exposure. These HDs must be stored in an externally ventilated, negative pressure room. Sterile and nonsterile HDs may be stored together but the HDs used for non sterile compounding should not be stored in areas designated for sterile compounding to minimize traffic into sterile compounding areas. Refrigerated antineoplastic HDs must be stored in a dedicated refrigerator in a negative pressure area Clean equipment should be dedicated for use with HDs and should be decontaminated after every use tablet/capsule forms of antineoplastic HDs must not be placed in automated counting machines Disposable or clean equipment for compounding (mortars/pestles/spatulas) must be dedicated for use with HDs APIs or other powdered HDs must be handled in a C-PEC to protect against occupational exposure, especially during particle-generating  activities (such as crushing tablets, opening capsules, and weighing powder) HDs must be delivered to the HD storage area immediately after unpacking & a spill kit must be accessible in the receiving area PPE including chemotherapy gloves must be worn when unpacking HDs Preparation of HD (even a very low volume) may not be done outside of a negative pressure area Sterile and nonsterile HDs must be compounded within a C-PEC (containment primary engineering control) located in a C_SEC (containment segregated compounding area) the C-SEC used for sterile and nonsterile compounding must be: externally vented, physically separated from prep areas, and at a neg pressure All C-PECs used for manipulation of sterile HD must be externally vented. Sterile HD compounding must be preformed in a C PEC that provides an ISO class 5 or better air quality, such as a class 2 or 3 BSC or CACI If compounding both sterile and nonsterile HDs the CPECs must be placed in separate rooms unless the CPECs used for nonsterile compounding are sufficiently effective that room can maintain ISO 7 air throughout nonsterile compounding. If CPECs for sterile & nonsterile compounding are in the same room must be 1 meter apart A sink must be available for hand washing. An eyewash station must be readily available  All containers of hazardous chemicals must be labeled, staggered or marked with identity & hazard warnings Must all have designated area for receipt, unpacking, storage or HD And designated areas for nonsterile compounding and separately for sterile compounding Certain areas are required to have neg pressure to contain hazardous drugs and minimize risk Signs designating hazard must be prominently displayed at the entrance to HD areas Schedules Amphetamine/dextroamphetamine: schedule 2 Dronabinol (oral cap): schedule 3 Clonazepam : schedule 4 Butalbital/ASA/caffeine: schedule 3 Pregabalin : schedule 4 Alprazolam : schedule 4 Lorazepam : schedule 4 APAP/codeine (tylenol #3) : schedule 3 Zaleplon: schedule 4 Fentanyl : schedule 2 Hydromorphone: schedule 2 Butorphanol : Schedule 4 Testosterone : schedule 3 Survorexant : schedule 4 Eszopiclone : schedule 4 Lacosamide : schedule 5 Dexmethylphenidate : schedule 2 Ketamine : schedule 3 Tapentadol : schedule 2  Meperidine: schedule 2 Lisdexamfetamine: schedule 2 Nabilone : schedule 2 Modafinil : schedule 4 Midazolam : schedule 4 Meprobamate: schedule 4 Oxycodone: schedule 2 Carisoprodol : schedule 4 Diazepam: schedule 4 Buprenorphine: schedule 3 Methadone : schedule 2 Methylphenidate : schedule 2 Armodafinil : schedule 4 Morphine sulfate: schedule 2 Phenobarbital : schedule 4 Clobazam : schedule 4 Zolpidem : schedule 4 Tramadol : schedule 4 Hydrocodone + APAP: schedule 2