Federal Requirements part 2

Federal Anti-tampering Act

(1983)

• Mandates that OTC drug products must be tamper evidence sealed

• Sometimes called the Tylenol Act. It was passed in response to the deaths of 7 people who took Tylenol capsules that had been laced with cyanide in Chicago

Prescription Drug Marketing Act

(1987)

• Prohibits the selling, purchasing, and trading of prescription drug samples

• Limits the distribution of drug samples only to those licensed to prescribe them, if requested

Omnibus Budget Reconciliation Act (OBRA)

(1990)

1.Drug Utilization Review (DUR)

• DUR requires pharmacists to review if the prescription is necessary and appropriate

• Two types of DUR-

• Prospective: Performed by pharmacist before a drug is dispensed to evaluate therapeutic duplicates, interaction allergies, ect.

• Retrospective- Performed after a patient has received the meds to detect prescribing pr dispensing patterns

Dietary Supplement Health and Education Act (DSHEA)

(1994)

• Under the act, dietary supplements are considered food, Meaning dietary supplements do not have to be approved as a new drug by FDA.

Health Insurance Portability and Accountability Act (HIPAA)

(1996)

• Limits the use and disclosure of protected health info. PHI to the minimum necessary

• Options for patients to obtain a copy of health records and request corrections

• If PHI is exposed to unauthorized parties, the affected individuals must be notified.

Food and Drug Administration Modernization Act (FDAMA)

(1997)

• Eliminates certain labeling requirements

• Example- the statement “Caution: federal law prohibits dispensing without a prescription” is shortened to “Rx only”

Drug Addiction Treatments Act (DATA)

(2000)

• Allows qualified prescribers to complete training and register for a NADEAN (Narcotic Addiction DEA#)

• A NADEAN (a special DEA # that begins with the letter “X”)

• Enables them to prescribe Schedule III, IV, and V controlled substances indicated for the treatment of an opioid disorder (OUD) outside and addiction treatment center

• Note: Buprenorphine is the most commonly prescribed medication for (OUD)

Combat Methamphetamine Epidemic Act (CMEA)

(2005)

• Regulates the sale of OTC products containing PSE, which can be used illegally to manufacture meth

• Requires that customers ID to purchase PSE products

• Daily limit 3.6 grams/day per customer

• No more than 9 grams per 30 days if purchased in store

• No more than 7.5 grams per 30 days if purchased via mail order

• Pharmacies must keep a written or electronic records of all OTC sales of PSE and ephedrine products of 2 years

• As a part of CMEA annual certification is required for all sellers of PSE and ephedrine products

Poison Prevention Packaging Act (PPPA)

(1970)

• Aims to protect young children from poisoning and deaths when they gain access to hazardous products like medications

• Child resistant packaging