Pharmacy Compliance Facts

How often the OIG exclusion list (LEIE) is updated

Monthly

Scope:

Federal - HHS Office of Inspector General LEIE

Method:

OIG publishes the full LEIE file plus monthly supplements; guidance points to monthly screening of staff and vendors.

As of:

2026

Breach size that triggers HHS + media notification

500 individuals

Scope:

Federal - HIPAA Breach Notification Rule

Method:

Breaches of unsecured PHI affecting 500+ individuals must be reported to HHS and prominent media without unreasonable delay (45 CFR 164.408).

As of:

2026

Deadline to notify affected individuals of a breach

Within 60 days

Scope:

Federal - HIPAA Breach Notification Rule

Method:

Individual notice must go out without unreasonable delay and no later than 60 calendar days after discovery (45 CFR 164.404).

As of:

2026

How often a pharmacy renews its DEA registration

Every 3 years

Scope:

Federal - Controlled Substances Act

Method:

Retail pharmacy DEA registrations (applied for on Form 224) are renewed on a three-year cycle (21 CFR 1301.13).

As of:

2026

Number of federal controlled-substance schedules

5 (Schedules I-V)

Scope:

Federal - Controlled Substances Act

Method:

Substances are classified into five schedules by abuse potential and accepted medical use (21 USC 812).

As of:

2026

How often a controlled-substance inventory is required

Every 2 years (biennial)

Scope:

Federal - DEA recordkeeping

Method:

Registrants must take a new inventory of controlled substances at least every two years (21 CFR 1304.11).

As of:

2026

When Medicare Part D price concessions moved to point of sale

January 1, 2024

Scope:

Federal - CMS Part D (DIR reform)

Method:

A CMS final rule requires all price concessions a plan can reasonably determine to be reflected in the negotiated price at the point of sale, effective for the 2024 plan year.

As of:

2024

USP chapter governing safe handling of hazardous drugs

USP <800>

Scope:

USP-NF general chapter (adopted via state boards/accreditors)

Method:

USP <800> sets standards for receipt, storage, compounding, and disposal of hazardous drugs to protect workers, patients, and the environment.

As of:

2026

Year the Drug Supply Chain Security Act was enacted

2013

Scope:

Federal - Title II of the Drug Quality and Security Act

Method:

DSCSA established a phased path to electronic, interoperable, unit-level tracing of prescription drugs through the supply chain.

As of:

2026

Structure of HIPAA civil monetary penalties

4 tiers, inflation-adjusted yearly

Scope:

Federal - HHS Office for Civil Rights

Method:

Penalties are tiered by culpability (from "did not know" to "willful neglect, not corrected") with minimum and maximum amounts that HHS adjusts for inflation annually.

As of:

2026