Federal Requirements

Pure Food and Drug Act

1906

Prohibits interstate commerce of misbranded/adulterated drugs/foods. Created FDA

Misbranded

Label inaccurate, incomplete. misleading

Adulterated

Fails to meet quality, strength or purity

Federal Food, Drug, and Cosmetic Act

1938

Requires drug manufacturers to provide FDA w/ evidence of safety through New Drug application before sale

Created FDA for regulation

Durham-Humphrey Amendment 

1951

Legend drugs (prescription) vs OTC

Legend drug labels: Caution: Federal law prohibits dispensing w/o prescription 

Kefauver-Harris Amendment 

1962

AKA Drug efficacy amendment 

Drug manufacturers must prove med is not only safe but effective

Invalidated FDA’s automatic 60-day approval

Controlled Substances Act (CSA)

1970

Regulates controlled substances and puts them into 5 schedules CI-CV

Placed in schedules based on medical use and abuse potential

Schedule I

High potential for abuse/dependence. No accepted use are are considered investigational/illicit

Heroin, weed (CI federally by DEA), methaqualone.

Schedule II

High potential for abuse/dependence but considered medically acceptable/necessary.

Stricter regulations compared to CIII-CV.

Narcotics: Codeine, Morphine, Oxycodone.

Stimulants: Methylphenidate, Amphetamine.

Schedule III

Moderate-low potential for physical dependance but high potential for psychological dependence.

Anabolic steroids, buprenorphine, codeine combos. 

Schedule IV

Low potential for abuse/dependence but can still lead to addiction and dangerous when combined w/ other substances. 

Benzodiazepines: Alprazolam.

Muscle Relaxants: Carisoprodol, Tramadol, Zolpidem.

Schedule V

Low potential for abuse/dependence.

Antidiarrheals: Atropine/diphenoxylate

Antitussives: guaifenesin/codeine 

Who implements CSA?

Drug Enforcement Agency (DEA)

Must be registered with DEA to order, handle, store, distribute controlled substances. Waived for any official of US army, navy, marines, Air Force, public health services, or bureau of prison. 

When do prescriptions for non-controlled substances expire?

1 year after date written 

When federal/state laws are different which do you follow?

The stricter one. 

C II Refills

NO, prescription must be issued for each fill. Prescribers can issue 3 30 day supply prescriptions to create 90 day supply, the date for all 3 must be the same and a “Do not fill until/before” date on 2nd and 3rd. 

CIII-IV Refills

Up to 5 refills or up to 6 months from date of issue, whichever comes 1st

CV Refills

Refilled as many times as authorized per federal law, state laws may differ

CS Expiration

CII - No expiration per federal law but may due to state law/company policy

CIII-IV - valid for 6 months from date of issuance

CV - No expiration per federal law but may due to state law/company policy

CS Prescription partial fills

CII - partial fill permitted as long as remainder is filled within 72 hours, the remainder is void, and the prescriber must be notified. 

CIII-V - partial fill permitted, no time limit as long as prescription not expired. 

Transferring CS for refill

CII: Prohibited

CIII-V: one time transfer between two pharmacies. But pharmacies electronically sharing a real time database can transfer max refilled permitted by law and prescriber. 

Records of CS

CII: stored separately from all prescriptions. Not sent to DEA but must be kept on file for at least 2 years.

CIII-V: stored separately or marked in lower right corner with “C” in red 1 inch high. 

CS Inventory

Initial: Issued DEA registration, pharmacy must count all CS in possession and record this info. 

Biennial: New CS inventory at least every 2 years.

CII products: stored in secure locked cabinet

CIII-V products: stored in secure locked cabinet OR dispersed but that deters theft/diversion

What DEA form to document receiving/distributing CII CS?

DEA Form 222

Must be kept on file for at least 2 years.

DEA controlled substance ordering system (CSOS) allows secure online ordering w/o form 222.

CIII-V: can use invoices. 

Disposal of CS

on-site disposal must be in presence of DEA agent/authorized personnel. 

When utilizing reverse distributor, must be documented on?

DEA form 222. Reverse distributor is processor that receives expired/unwanted CS and returns it to manufacture or arranges disposal. Returns/recalls must be delivered to source of purchase and must be on form.

Info for CS prescription

Patient’s name and address, prescriber’s name/address/DEA #/signature, drug name/strength/dosage form, qty prescribed, date issued, directions. 

Prescriber must physically sign prescription. 

DEA Form 41

destruction of CS

DEA Form 222 Layout

Original triplicate w/ different inks and carbon in between to copy what is written on top layer but phased out in October 2021.

1st page: brown ink for CS supplier

2nd: green ink for DEA

3rd: blue ink for pharmacy for 2 yrs

New single sheet as of 2019: purchaser makes copy and submits original to supplier. Supplier must provide copy of each original single sheet to the DEA which must be mailed/emailed by close of the month during order fill. 

DEA Form 106

Loss/theft CS

DEA Form 104

Pharmacy closure or surrender of pharmacy permit 

DEA Form 224

Applying for DEA # and renewal (every 3 yr)

DEA # Verification

Must be on face of all CS prescriptions or provide over phone. 2 letters followed by 7 #

DEA # 1st letter

Practitioner

A/B/F: physicians, dentists, vets, pharmacies, hospitals

M: allied health (mid-level): PhysicianAssistant and NursePractitioner

P/R: manufactures, distributors, narcotic treatment programs, researchers

DEA # 2nd letter

1st letter of prescriber’s last name or 1st letter of business name of hospital/pharmacy 

How to verify DEA #

1: Add 1st, 3rd, 5th digits

2: Add 2nd, 4th, 6th digits and multiply by 2 

3: Add step 1 and 2 

4: Sum of step 3 will be 2 digit #. 2nd digit will match 7th digit of DEA #

PPPA

Poison Prevention Packaging Act

1970

Requires most OTC/legend drugs to be packaged in child-resistant containers for children under 5 but not too difficult for adults. Not child proof, delay time of open. 

Exempt: sublingual nitroglycerin, effervescent acetaminophen, effervescent aspirin, oral contraceptives, hormone replacement therapy. 

Federal Anti-Tampering Act

1983

OTC must have tamper seal.

Tylenol Act bc 7 ppl died who took Tylenol capsules laced with cyanide in Chicago. 

Prescription Drug Marketing Act

1987

Prohibits selling, purchasing, trading of prescription drug samples; only to those licensed to prescribe. 

OBRA

Omnibus Budget Reconciliation Act

1990

Drug utilization review, patient counseling standards, patient record maintenance. 

DUR (M(ed)UR)

Drug Utilization Review

Requires pharmacist to review if prescription is necessary.

2 types: prospective - Before drug is dispensed and retrospective - after patient has received med and used to detect prescribing/dispensing patterns

Prospective DUR

Therapeutic duplication: multiple drugs for same drug class/indication

Drug interaction: drug-drug/drug-disease

Drug allergies

Over/under utilization: dosage/duration appropriate

Potential misuse: signs of drug abuse

Patient counseling standards

offer of counsel to patient, directing patient counseling to pharmacist.

Drug name, use, action, route, dose, side effects, storage, interactions, action if miss dose. 

Patient record maintenance

Update name, DOB, address, phone #, gender, allergies, chronic conditions, insurance, complete record of meds.

Originally created for Medicaid patients to reduce federal spending. 

DSHEA

1994

Dietary Supplement Health and Education Act

Vitamins/herbal supplements are considered food. Don’t have to be approved for investigation as new drug

HIPPA

1996

Health Insurance Portability and Accountability Act

Limits disclosure of protected health info (PHI) to minimum necessary. Provides patient copy of health record and to request corrections. If PHI is exposed, patient must be notified. 

FDAMA

1997

Food and Drug Administration Modernization Act 

Eliminated certain labeling requirements such as “Caution: Federal law prohibits dispensing  w/o prescription” to “RX only” 

Drug Addiction Treatment Act (DATA)

2000

Allows prescriber to train/register for NADEAN (Narcotic addiction DEA#): DEA begins with X, enables prescribing for CIII-V for opioid use disorder (OUD) outside of an addiction treatment center. Often prescribed: buprenorphine and must have NADEAN and DEA#

Combat Methamphetamine Epidemic Act (CMEA)

2005

Regulates sale of OTC containing pseudephrine and ephedrine (used to make meth). Must be kept locked, ID to purchase, purchase limits (3.6g/day, no more than 9g per 30 days in-store, no more than 7.5g per 30d via mail/mobile retail vendor), pharmacies must keep record for at least 2yr including: product name, qty sold, name/address/signature, date/date of sale. Annual certification required for all sellers

FDA

Food and Drug Administration is responsible for protecting public health by assuring the safety, efficacy, security of drugs, biological products, medical devices, food, cosmetics. 

DEA

Drug enforcement administration regulates legal trade of narcotic drugs. 

CDC

Centers for disease control and prevention protects public health/safety through investigation, identification, control of diseases. Oversees National Institute of Occupational Safety and Health. (NIOSH)

CMS

Centers for medicare/medicaid regulates administration of medicare, medicaid, state children’s hospital insurance program, the health insurance portability and accountability act. 

TJC

The joint commission evaluates health care organizations.

OSHA

Occupational safety and health administration ensures safety of workers with standards. 

BOP

State boards of pharmacy is a state agency that registers/regulates pharmacies. 

The medical device amendment

1976

premarket approval by FDA

Orphan drug act

1983

drugs for rare diseases 

Drug price competition and patent term restoration act

1984

established generic drugs 

Anabolic steroid control act

1990

placed anabolic steroids in CII