Federal Requirements

Handling Hazardous Drugs(Compounding):

  • PPE must be worn

  • tablets should not be cut & capsules should not be opened

Adulteration: when a drug product or device is contaminated, impure, or is not of the advertised strength

Misbranding: when a drug product is associated with false or misleading labeling or advertising

Legend Drug: prescription only drugs, must contain Rx only on it

Drug Take Back Program: allows patients to return any expired or unused medications to an authorized medication collection site for proper disposal

OSHA (Occupational safety and health administration): government agency that helps protect employees and healthcare workers from exposure to potentially hazardous substances and chemicals

  • requires the MSDS (material safety data sheets), contains info on chemicals, characteristics, flammability, volatility, storage requirements, exposure prevention, and what do in case of spill or exposure

Poison Prevention Packagina Act of 1970: requires that medications be packaged in child proof containers, 80% of children cannot open

2005 Combat Methamphetamine Epidemic Act: restricted the OTC sales of pseudoephedrine, ephedrine, and phenylpropanolamine

  • max of 3.6 g per day or 9 g per month (7.5 g/month for mail order/online pharmacies)

  • must be >18 and show photo ID

REMS (risk evaluation and mitigation strategy): drug safety program required by the FDA for certain medications that prose serious safety concerns

  • accutane, clozaril, pomalyst, revlimid, and thalomid

Drug Supply Chain Security Act (DSCSA - 2013): in effort to reduce the prevalence of counterfiet drugs

  • created a drug pedigree, a national tracing system for medications

  • established national licensing standards for wholesale distribution

Omnibus Budget Reconciliation act of 1990: elevated elevated the strandards for drug for rug therapy reviews and patient counseling in the pharmacy setting (only apply to medicaid patients)

  • pharmacist must conduct a review a drug therapy prior to dispensing each prescription, which involves screening for the therapeutic duplitcations, drug interactions, allergies, and contrindications

HIPAA (Health insurance POrtability and Accountability Act of 1996): sets national standards for the privacy and security of health information

  • PHI (protected health information)

  • PPI (patient package inserts, or medication guides): informational leaflets designed to educate patients about a medication

    • oral contraceptives, IUDs, estrogen or progesterone containing products, and isproterenol inhalation REQUIRE PPI

___________________________________________________________________________

  • for non controlled substances, prescriptions may be accepted by written hard copy, electronic transmission, facsimile transmission, verbal telephone order, or verbal voicemail telephone message

  • no limits for refills alllowed for noncontrolled substances

  • prescriptions expires 12 months from the date written

  • if non controlled substances are stolen/missing → no need to notify the DEA

  • if CONTROLLED substances in any schedule are missing/stolen, the pharmacy must notify the DEA

  • Presctiption and OTC drugs undergo the same drug approval process through the FDA and must be proven to be safe and effective

    • drug advertising for OTC medications is regulated by the Federal Trade Commission

  • Technicians are able to order Schedules III, IV, and V controlled med & non controlled, EXCEPT FOR Schedule II substances

__________________________________________________________________________

DEA Form 106: provides an estimate of what medication is known to be stolen or missing, must be sent to the DEA within 1 business day of the discovery of the theft or loss of controlled substances

  • OG copy goes to DEA, and a copy stays at the pharmacy for at least 2 years

DEA Form 222: to order schedule I & II controlled substances

  • Copy 1(brown) → kept by the supplier

  • Copy2 (green) → sent to the DEA by the supplier at the end of the month

  • Copy 3 (blue) → kept by the purchaser/pharmacy, must be stored for 2 years

DEA Form 224: controlled substance registration for manufacturers, distributors, or dispensers that wish to handle controlled substances

DEA Form 41: controlled substance destruction/disposal

  • can be transferred ot returned to an authorized reverse distributor

  • may be destroyed in front of an authorized DEA member

  • hospital authorized to immediately destroy controlled substances on site

DEA Form 106: to report theft or loss of controlled substances

___________________________________________________________________________

DEA #:

An identifier assigned to any healthcare provider that prescribes or dispenses controlled substances

  • Medical doctors, doctors of osteopathy, vets, dentists, and podiatrists = A, B, or F

  • Midlevel practitioners (PA, CRNA) = M

  • Prescribers authorized to prescribe under a narcotic treatment program = X

*Second Letter is the first letter of the prescriber’s last name*

  1. Add digits 1+3+5

  2. Add digits 2+4+6 and multiply this number by 2

  3. Calculate the total sum from steps 1 and 2

  4. The last digit of the total sum should equal the seventh digit of the DEA number

___________________________________________________________________________

Controlled Substance Classes/Schedules:

Schedule 1 → Drugs that have a high potential for abuse and no medical purpose (cannot be obtained w/o a special license)

  • Ex) Heroin, illicit Drugs

Schedule 2 → Drugs that have a high potential for abuse but have accepted medical uses

  • Ex) most opiods (oxycodone, morphine, hydrocodone), methadone, cocaine

  • CANNOT be refilled, but can be parially filled if the remaining quantity is dispensed within 72 hours

  • CANNOT be ordered through the phone

Schedule 3 → Drugs that have less potential for abuse than schedule II drugs but can still cause low to moderate physical or psychological dependence

  • Ex) Anabolic steroids, ketamine

  • may be refilled up to 5 times within 6 months/ can be partially filled

Schedule 4 → less potential for abuse than schedule II but can still lead to limited physical or psychological dependence

  • Ex) Benzodiazepines, sleeping tablets, propoxyphene

  • may be refilled up to 5 times within 6 months/ can be partially filled

Schedule 5 → Drugs that have some potential for abuse but can still cause limited physical or psychological dependence (can be sold OTC)

  • Ex) diphenoxylate, pregabalin, promethazine with codeine cough syrup

  • normally combo products that contain a schedule II, III, or IV

___________________________________________________________________________

Drug Recall Classes: 

  • Vitamin & supplement recalls are rare

Class I: Drugs or devices that can cause SERIOUS adverse health consequences or death if administered

  • all affected stock in the pahrmacy must be isolated

  • patients must return medication to the pharmacy

Class II: Drugs or devices that could cause temporary reversible effects or have a SMALL chance of causing serious adverse effects if administered

  • stock must be isolated, but a notice to patients is not usually required

Class III: drugs or devices that are unlikely to cause any adverse health effects if administered (recalls are voluntary)

___________________________________________________________________________

Medicare Parts: