PTCB Federal requirements

2025

Food and Drug Administration (FDA)

Governing body over medications sold in the US, Branch of US health an and human services, and responsible for approval of prescription and OTC medications, drug labeling and standards for manufacturing 

Centers for Disease Control (CDC)

Provides regulation for infection control, publishes annual vaccine and immunization requirements, involved with national health issue

Drug Enforcement Administration

Enforces the laws and regulations surrounding controlled and illegal substances and sets requirements for dispensing and refilling controlled substances

The Pure Food and Drug Act 1906

First law to regulate medication, prohibits falsely labeling pharmaceutical products and prohibits sale of contaminated products or those with unknown contents  

Misbranding

Falsely labeling pharmaceutical products

Adulteration

Sale of contaminated products or unknown contents

Food, Drug and Cosmetic Act of 1938

Created amendments to Pure Food and Drug Act of 1906, Expanded the role of FDA(eg. the authority to approve or deny new drugs coming to market) and requires pharmaceutical manufacturers to prove a drug’s purity, strength and safety before it can be sold. 

Durham-Humphrey Amendment of 1951

Created the 2 classes of medications (otc and rx), requires prescription-only medications to have “Rx Only” stated on the medication label, and OTC labeling must contain active and inactive ingredients, purposes or uses, warnings and dosage instructions. 

Poison Prevention Packaging Act of 1970 (PPPA) 

Authorized by the Consumer Product Safety Commission (CPSC), standard for packaging to protect children form taking harmful medications 

Child-Resistant Packaging

Cannot be opened by 80% of children younger than 5 and can be opened by 90% of adults 

Medications that do not require Child-resistant packaging

Sublingual nitroglycerin, oral contraceptives in memory-aid packaging , inhalers, inpatient meds, some OTC medications, and some vitamins and supplements 

Child-Resistant Packaging Waiver

Patients may optout of child-resistant packaging by authorizing the pharmacy to use easy open containers 

Patient Package Insert

Contains information similar to a package insert, written in an easy to read format, designed specifically for patients, generally attached to the stock bottle or body of the bottle, and is considered to be apart of the product’s labeling. 

Medications that require a Patient Package Insert

Oral contraceptives and estrogen containing medications.

PPI requirements for outpatient pharmacies

Must be dispensed with every oral contraceptive and estrogen-containing prescription including refills

PPI requirements for inpatient pharmacies

Must be dispensed before the first dose of oral contraceptive or estrogen medication is administered and must be given once every 30 days thereafter as long as therapy continues 

Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman act)

Allows manufactures to submit abbreviated new drug applications (ANDA) to market generic products, generic manufacturers don’t have to go through the entire approval process, Have to prove these medications safe and effective, FDA approves the applications for generic medications, allows for less expensive alternatives to be available to patients faster. 

Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90)

Requires a pharmacist to discuss information about new and refill prescriptions with patients and only basic requirements are provided by federal laws and specific requirements are detailed in state laws 

Dietary Supplement Health and Education Act of 1994 (DSHEA)

Requires supplements to be treated more like drugs than foods, dietary supplements can only state the intended effect on the body, labels cannot say the supplement can treat, prevent or cure a specific disease or condition and FDA can intervene if a product is proven harmful, unsafe or mislabeled 

Drug Imprint Codes 

Required by the FDA, must be on the surface of the product, generally stamped with the strength or part of the NDC # and can also be stamped with drugs name or the manufacturers logo 

Why do we have imprint codes?

Identification of individual meds that might be separated from their container, clarify misfiled prescriptions and can help identify counterfeit drugs

Drug Listing Act of 1972

Requires each new drug to have a unique and permanent product code or National Drug Code (NDC)

MedGuide Standards

Must contain specific, comprehensive, scientifically accurate information based on the package insert, ne written in non-technical English, identify that it is a medication guide, and contain clear headings and clear explanations 

Outpatient pharmacies must dispense a MedGuide: 

When asked for, with all prescriptions (new and refill), when the first does of a medication is dispensed that is going to be administered by another healthcare professional and when the medication is apart of REMS  

Original DEA 222 Form 

First page: Original, kept by CS supplier

Second page, (green) sent by supplier to DEA
Third page: (blue), retained by pharmacy for 2 years

Drug Addiction Treatment Act 2000 (DATA)

Allows prescribers to complete training and register for Narcotic Addiction DEA number 

DEA form 224

Application for new registration

Drug recall process

Recalled meds must be quarantined immediately then follow instructions provided by manufacture for removal, replacement or disposal

REMS

Risk Evaluation and Mitigation Strategies

Who determines REMS

FDA and manufacturer

How to verify a DEA#

1. Add the 1st, 3rd and 5th digit

2. Add 2nd, 4th and 6th digits 

3. Multiply answer of step 2 by 2 

4. Add answer of step 1 and step 3 together

5. The last digit of the DEA # must match the answer of step 4

P list waste

Warfarin, Nicotine patches, physostigmine, arsenic trioxide, nitroglycerin and epinephrine  

U-List waste

Lindane, selenium sulfide, chloral hydrate, mitomycin, formaldehyde and benzene

The Joint Commission (TJC)

Accredits and certifies healthcare organizations and sets standards for patient safety

US pharmacopeia (USP)

Sets standards for the quality, purity, strength and consistency of medications

USP 795

Non-sterile compounding

USP 797

Sterile compounding

USP 800

Guidelines for safe handling of hazardous drugs to minimize exposure 

Risk Evaluation Mitigation Strategies (REMS)

Required for drugs with serious safety concerns. Includes medication guides, communication plans and elements to assure safe use 

National Institute of Occupational Safety and Health (NIOSH)

Hazardous guidelines

United States Pharmacopeia (USP)

A body of information on the standards of strength, purity and quality of drugs; legal standard as of 1907; revised regularly 

United States Pharmacopeia-National Formulary (USP-NF) 

A combination of both the USP and National Formulary which was combined in 1975

Kefauver-Harris Amendment 1963

Requires drugs to proven to be both safe and effective 

Healthcare Insurance Portability and Accountability Act , 1996 (HIPAA)

The rights of patients over information kept on patient databases: access to records. Confidentially of PHI or protected healthcare information. 

FDA Modernization Act of 1997

Fast tracked the review of drugs treating serious conditions 

Medication Prescription Drug Improvement and Modernization Act of 2003

Created Medicare part D prescription coverage 

Drug quality and Security act of 2013

Regulates compounding pharmacies and establishes framework for track and trace system