Pharmacy regulations and controlled substances

• Emergency kits should contain a 24-hour supply of a maximum of 10 controlled substances, in unit dose packaging, with only 3 being injectables.
• All antineoplastic drugs need compounding in a vertical hood, class II biological safety cabinet, with PPE, and labeled both inside and outside with precautions, including a "chemo spill kit".
• The Department Of Health (DOH) must be notified immediately of theft/loss of controlled substances, even if recovered, with responsible parties identified and action taken against them.
• Schedule 2 controls cannot be orally prescribed for more than a 5-day supply.
• Schedule IV substances can be prescribed for 30 days or 100 units, whichever is less, except for Benzos, Sedatives, and Hypnotics, which are limited to a 5-day supply.
• NYS scripts must be received within 72 hours after filling an oral script.
• Pharmacists need to include their signature, date of filling, the prescription number it was filled under, and that it was a follow-up to an oral order on the prescription.
• If a written script is not received within 72 hours, the pharmacist should write "oral Rx not received," the Rx name, and the date, then put the order in the control file, place it on follow-up Rx with the date of receipt, Rx script number, and the date filled.
• Manufacturers/distributors can destroy controls with FDA approval, with a copy of the approval filed with the DOH within 30 days of receipt and keep the record for 5 years.
• Medical cannabis products must have a specific concentration of THC + CBD on the label, with no less than 90% or more than 110% total THC or CBD (MUST BE 21).
• Reports must include THCA, CBDA, any other phytocannabinoid (marketed or over 0.2%), and terpenoids content.
• Medical cannabis should not be smoked or vaporized where smoking is prohibited unless authorized by a research license.
• Medical cannabis consumption is prohibited in any motor vehicle (public or private), as defined by vehicle and traffic law.
• If a cannabis patient dies, the practitioner must report the death no more than 5 business days after becoming aware (report to the office).
• Expired patient cannabis in caregiver possession must be disposed of no later than 10 days after the expiration of patient certification.
• Standing orders for controls for individual patients in institutional dispensers (hospitals) only valid for 7 days and should be rewritten, unless the patient is stabilized with convulsive disorders, or at prisons/healthcare facilities with a class 3 control license, where they can be valid for 30 days.
• Practitioners do not have to send E-Scripts if they certify to the DOH that they will not issue more than 25 scripts in a 12-month period, including controls, and this must be renewed every 12 months.
• Practitioners must submit control substances dispensing data to the Bureau of Narcotic Enforcement (schedules II - IV) within 24 hours after delivery.
• If delivered by mail, the data must be submitted no later than 72 hours after shipping from the pharmacy.
• PMP (Prescription monitoring program registry) practitioners can designate staff to access the registry on their behalf.
• Consulting the PMP is required prior to prescribing schedule II, III, or IV drugs, except for a 5-day supply of control from the ED of a general hospital.
• Pharmacists selling or furnishing hypodermic needles or syringes with a script must include their signature and date of sale on the script (quantity dispensed not required).
• Buprenorphine is FDA-approved for narcotic addiction.
• Partially filled controls require notation of the amount given on the prescription, with the remaining portion filled within 72 hours (after that, need a new script), and an Rx signature is required for partial and date for terminally ill patients or those in RHCF.
• Control scripts are valid for 30 days.
• If a patient develops a new condition that requires a control, it can be dispensed if the MD has established an MD/patient relationship, it's an emergency with immediate use, there is no alternative available, and the script does not exceed a 5-day supply as determined by directions for use.
• Rx for filling controls must include the signature, date of filling, and Rx number of the pharmacist. Must keep records for 5 years and inform the BNE (bureau of narcotic enforcement) 24 hours after substance delivered
• MDs prescribing of controls, and Rxs filling of the control, are both responsible.
• MDs authorized to prescribe controls (MD, Dentist, Vet, Podiatrist) must do so within their usual course of practice.
• Emergency kits must be secured near the nursing station.
• In emergency kits, for medications other than controls, only injectables are allowed, except for sublingual nitroglycerin and up to 5 non-injectable prepackaged medications (not to exceed a 24-hour supply).
• The total number of non-injectables cannot exceed 25 for the entire facility.
• Preprinted scripts with strength/dosage/quality for controls cannot be used.
• Partially used blister packs can be re-dispensed only if returned, but cannot be emptied, repacked, or have medications added, and no drug from bulk dispensing containers can be returned, as well as no control can be returned.
• For drugs repacked into "unit dose or multi-dose Blister packs" in nursing homes, they can be returned if they have a date of repack, lot number, and expiration date that is clear on the package, no more than 90 days have elapsed from the repack date, and the repack is maintained in the pharmacy.
• Nursing homes can establish policies with vendors (Rx {Nursing Home} to Rx {Vendor}) to return unused medications that are sealed in unopened, individually packaged units within their shelf life for re-dispensing.
• Oral and parenteral medications in single-dose seals cannot be withdrawn, parenteral multidose seals cannot be withdrawn, and drugs must show no signs of deterioration.
• If an electronic prescription fails, annotate the oral/unwritten Rx as a replacement for the Electronic Prescription (To OG Pharmacy).
• CPR, BLS, and ACLS are acceptable towards CE's, equivalent to 5 hours worth, but first aid is not accepted.
• NPs, Midwives, and PAs can prescribe controls and must report to the BNE within 24 hours.
• There are three types of control filing systems: one folder for C2's, one folder for C3, C4, and C5, and one folder for non-controls.
• Mid-level practitioners have specific abilities to prescribe and administer C2-5 drugs.
• Animal Shelters (AS) can administer and procure C2 and C5 drugs.
• NPs and Nurse Midwives can prescribe, administer, dispense and procure C2-5 drugs.
• PAs can prescribe ONLY C2–5 drugs.
• "Drug Adulterant Testing Supplies" are products used to determine if a control substance contains fentanyl or a fentanyl analog.
• The supplies are stored in licensed Pharmacies, clinics, medical offices, and any healthcare professional or pharmacist setting.
• Any healthcare professional or pharmacist is authorized to dispense the supplies to any person.
• The quality of drug testing supplies should not exceed what is necessary to perform 5 assays of substances in a single transaction.
• An Rx can execute non-patient specific orders for dispensing a 7-day starter pack of HIV post-exposure prophylaxis medications by an MD or NP in NYS.
• An Rx can execute non-patient specific orders for insulin and supplies to someone with a valid script for such, which has expired within the last 12 months from an MD or NP certified in NYS.
• For emergency prescriptions, an attempt must be made to get authorization from the MD of the patient-specific script (but cannot), but the MD does not object to dispensing patients under a non-specific regimen.
• The refill of the exact script quantity (conformed to directions) cannot exceed a 30-day supply, and the MD must be informed within 72 hours of dispensing the refill.

Quiz 1

• If the DOH does not grant approval to destroy controls, it must be surrendered to the Bureau of Narcotic Enforcement and the date must be requested.
• In the surrender documentation include: the inventory, 2 persons who conducted the inventory (licensed practitioners like Rxs, nurses), the reason for surrender of each substance, and the proposed date for surrender and alt date.
• Receive a surrender date in writing from the BNE and ship controls no later than 5 days from the date the BNE set, and keep record for 5 years.
• In a medical emergency and if only the brand-name medication is available, it can be dispensed at the regular price, with the date, hour, and nature of the medical emergency recorded on the back of the script or within electronic records.
• The State Board of Pharmacy is appointed by Regents on the recommendation of the commissioner.
• The State Board consists of at least 9 Rxs licensed in NYS for at least 5 years, plus 2 registered pharmacy technicians.
• The executive secretary of the board regulates the practice of pharmacies and registered techs, employment of interns and employees in pharmacies.
• They also regulate and control the sale, distribution, character, and standard of drugs, poisons, cosmetics, devices, and new drugs.
• They prevent the sale or distribution of anything that does not conform to public health law, investigate alleged violations of these terms, and issue permits or registrations.
• The opioid overdose prevention program director/ or someone designated by director must be documented.
• Schedule A poisons include: Arsenic, Atropine, Potassium Cyanide, Chloral Hydrate, Hydrocyanic Acid, Strychnine.
• Schedule B poisons are those liable to be destructive to human life in quantities of 60 grains or less.
• Every person who purchases poison must write: Date of sale, Name + address of purchaser, Name + quantity of poison, Purpose for purchase of poison, and Name of dispenser, and these records must be kept for 5 years.
• A copy of a controlled substance script cannot be given to the patient, but can be given to a practitioner who can prescribe controls.
• Copies of other scripts can be given to patients for purposes of the prescriber only and shall be worded as such.
• CIII, IV, and V substances cannot be transferred, and only 1 refill of scripts can be transferred at a time, and "refill transfer" must be put if receiving pharmacy.
• Schedule II drugs include: Alfentanil (Alfenta), Amobantal (Amytal, Tuinal), Amphetamine (Dexedrine, Biphetamine), Lisdexamfetamine (Vyvanse), and Methylphenidate (Ritalin).
• In NYS, all schedule IV Benzos are classified as C2 drugs, which means that there are no refills.
• Anabolic steroids are also classified as C2.
• The limit is no more than 300 mg of hydrocodone per 100ml or no more than 15mg/unit.
• If there is a class 1 recall of a drug, pharmacies must attempt to contact patients within 3 days of the pharmacy being notified by the FDA, manufacturer, or wholesaler, (can be independent Pharmacy or Headquarter).
• Prior Authorization (PA) is NOT required for buprenorphine products, methadone, any long-acting injectable naltrexone, or detox/maintenance treatment of substance use disorder.
• Schedule 1 drugs require DEA 222 Forms to Purchase, and include: Difenoxin (lyspafen), Dihydromorphine, Heroin (diacetylmorphine, diamorphine), LSD (lysergide), and marijuana.

Quiz 2

• Prescription forms of the deceased should be returned to BNE, NY DOH, or its designee at the designated address by the practitioner's estate or lawful designee.

• A preferred drug program should be available 24/7 and have a toll-free number to respond to requests for PAs.

• It must include qualified healthcare professionals to consult with prescribers.

• Telehealth includes assessment, diagnosis, consultation, treatment, education, care management, and/or self-management.

• Remote monitoring involves collecting personal information from patients at different sites, and NPs, MDs, and Midwives can order it.

• Control labeling must include: The name of the patient for whom it is intended (or if an animal, the species + name + address of the owner), the name, address, and phone number of the practitioner, specific directions for use, dosage, frequency, Max Daily Dose, "Controlled substance, dangerous unless used as directed", Date of dispensing, Name of substance, and have an orange label / orange transparent adhesive tape/ orange aux that cannot be removed.

• DAW must be written (no stamp).

• Nuclear pharmacists must have a Certificate of Nuclear pharmacy by the Board of Pharm specialties of American Pharm. Association OR a minimum of 200 contact hours + 500 clinical hours.

• It must be returned to BNE, NY DOH, or its designee at the designated address by the practitioner estate or lawful designee

• The preferred drug program is available 24/7 and has a toll-free number to respond to requests for PAs. It includes qualified health care professionals.

• Telehealth includes assessment, diagnosis, consultation, treatment, education, care management and/or self management.

• Remote patient monitoring collecting personal information from patients from different sites, can be monitored by NP, MD, and Midwife

• The Control Labeling requires the: Name of patient (or animal & its owner), Practitioner, specific directions & "controlled substance, dangerous unless used as directed", date of dispensing, orange label that cannot be removed.

• DAW must be written without a stamp.

• If mixture contains less than 1.89 gms codeine per 100cc = C3 (Ketamine is C3).

• Marihuana must have been extracted only from leaves / flowers of a female plant, 99.5% pure has to be used. Product with <90% total THC or with >110% must be labeled. The daily dose should be around 10mg. BUT, THC<5mg/doze, concentration should also < 0.5mg/CBD in product with <5mg/ doze

• Org. shall offer on brand must offer ↓THC = ↑CBD and One that has THC = CBD

• Schedule V Drugs include: Codeine preparations (Robitussin AC, Phenergh with codeine), Derenoxon preps (Motofen), Hydrocodone preps, DiPheroxylate preps (Lomotil, Logen), Opium preps (parepectolin, Kapectolin PG, kaolin pectin PG), Lyrica - pregabalin, Vimpat - Lacosamide, Potiga - ezogabine, x copri - cenobite, Reyvow, Ztalmy - ganatolone, and PyRovalerone.

• Fiorinal (Butalbital with Aspirin) and Fioricet (Butalbital with Acetaminophen) are both C3 drugs, and federal regs classify any barbitone acid derivative combined with inactives as C3.

• NY State has stricter regulatory thresholds with the drugs: Fiorinal containing 325 ASP. and. 50 Barb and 40 caffeine, and Fioricet containing 325 ACET. and 50 barb 40 caffeine, are C3 drugs. Fioncet is not scheduled In NYS

• For CE's (continued education), 45 hrs every 3yrs, with 23 out of 45 as live course, 3 hrs must be dedicated to compounding (3 creds), 3 hrs must be dedicated to reduce medication errors (3 creds), and no more than 22 self study hours are allowed. CPR, BLS, ACLS, and EMT courses must be sponsored by American Red Cross ®, American Heart Association ®, American safety + Health institute or National Safety Council like First aid.

• CPR = 5 hours CE; recertification hours = 3 CE hours, BLS = 5 hours CE; recertification hours = 3 CE hours, ACLS = 12 hours CE; recertification hours = 5 CE, so the Card Issues upon completion would proof CE.

• In case for Conditional registration, 1 yr (if not compliant with CE's ) → Must complete CE's at rate of 1 1 hours/month. Complete additional CE's during 1 regular period the renewals or extensions past 1 year.

• The Certificate of registration: is valid only to address on certificate, or other boards requests within 30 days before locations are approved, so for the Board must be notified within 30 days of any changes in officers of corp. or in stockholders with 10% or more of the stock in Corp., and must notify board within 48hrs of fire of flood.

Quiz 4

• Drugs repacked for in-house use will expire in 12 months or 50% of the time remaining on the manufacturer's expiration date (whichever is less) from the date of repacking.

• If a PA request is not answered within 24 hours, PA is automatically granted

• C3 drug refills: no more refills allowed than the amount on the Rx, provided that the amount on the Rx does not equate to more than a five-day supply with (30 day).

• C3 drugs cannot be refilled >6 months.

• If the C3 quantity >30 refills, then only 1 REFILL is allowed.

• C2 drugs and Benzos CANNOT BE REFILLED

• Immunizations administered on non-patient-specific orders cannot be administered outside of the Advisory Committee on Immunization Practices (ACIP). Immunization reporting is only done above <19 years of age

• For immunization reporting with subjects <19 that occurs IN NYS → report to city immunization Registry (CIR), or if OUT OF NYS → report to NYS immunization info system (NYSLLS).

• If age <=19, the report in either: NYSIIS or CIR must have patient consent. Lastly, the health report must also get to the patient's primary MD within 1 month of consent. The physician has to write their opinion.

• Prescriptions should not prescribe >7 days' supply of C2, C3, and C4 for opioid users experiencing acute pain

• The process to certify patients for cannabis management requires a minimum of 2-hour course approved by the office of cannabis management

• Practitioners using medical cannabis must put the doctor's, business address, phone number, email, DEA code, Statement of licensure for controlling substance and its indication with a rec./limitations for if patient is temporary they must put extent to authorize use and MD signature, date, etc.

• All authorizations expire after ** Valid for 1yr unless a person is terminally (ill then until death) ^^^^^^^NEVER MORE THAN 1 YEAR, with the doctor also maintaining the certificate for 5 years

• Certified medical cannabis patients can designate up to 5 caregivers, as long as they are human and not a facility.

• A pharmacist may substitute a less expensive drug with the same active ingredients, dosage form, and strength as the product prescribed UNLESS the prescriber does not enable the substitution (no “DAW” on script) or for oral scripts: if it does not explicitly state if substitution is allowed or not; it cannot be filled.

• Pharmacists should place the name, strength of the medication, and manufacturer on the container unless the prescriber states otherwise.

• Reserve/ main stock of controlled substances should be kept secure in a locked safe, while "working" non-controlled substances can be stocked anywhere that theft cannot occur.

• A preceptor pharmacist can only have an intern or 2 part-time interns for a year and must be in practice for one year.

• If an electronic prescription is printed and given to a pharmacist, it is no longer electronic and is now considered a prescription.

• In hospitals, med orders for med-controlled substances that are “PRN” (pro re nata) are not valid after 72 hours and must be rewritten

• Emergency med-controlled substances must be given within 48 hours orally with a physician's annotation of signature for emergency use is required.

• Pharmacies are not required to keep a hard copy of electronic prescriptions as long as the electronic prescriptions of med have proof within 5 years for safe harbor. A retail pharmacy must also have med equipment.

• An application to renew cannabis registration must be filed with the office of cannabis management no more than 6 months and no less than 4 months prior to registration or else the renewal will be declined.

• A control prescription must be filled within 30 days of being written.

• Control drugs must be filled in < 30 days, or else it must be verified. A pharmacist cannot oversee more than 2 registered technicians to perform licensed tasks. Additionally, there are no more than 4 unlicensed technicians working with or without the tasks described