EXEMPTIONS
Act 96 includes a number of exemptions. Providers do not have
to comply with this mandate if any of the following apply:
1 If a veterinarian issues the prescription.
2 If the prescription is not available to be issued or received
due to a temporary technological or electrical failure
(in this situation, a provider must, within 72 hours, seek
to correct any cause for the failure that is reasonably
within his or her control).
3 The prescription is dispensed by a practitioner or pharmacy
located outside of Pennsylvania.
4 The prescription is prescribed by a provider who or a health
care facility that does not have either of the following:
• Internet access
• An electronic health record system
5 Instances when a provider treating a patient in an emergency
department or health care facility determines that it is
impractical for the patient to obtain the controlled substance
if it were prescribed electronically, or it would cause an
untimely delay that adversely impacts the patient’s
medical condition.
6
7
Prescriptions issued for patients enrolled in a hospice
program, and residents in a nursing home or residential
health care facility.
Situations in which controlled substance compounded
prescriptions and prescriptions containing certain elements
required by the FDA or any other governmental agency
cannot not be prescribed electronically.
8 Prescriptions issues pursuant to an established and valid
collaborative practice agreement between the provider
and pharmacist, a standing order or a drug research protocol.
9 Prescriptions issued in an emergency situation pursuant
to federal or state law, and Department of Health (DOH)
regulations.
10 Where the pharmacy that receives the prescription is not
set up to process electronic prescriptions.
11 Controlled substances that are not required to be reported
to the Prescription Drug Monitoring System (PDMP).
COMPLIANCE
The Pennsylvania General Assembly passed Act 96 of 2018, which
requires most health care providers to electronically prescribe
all Schedule II-V controlled substances, except when they are
directly dispensed or administered by the provider. This law took
effect on October 24, 2019.
If you have not yet taken the steps necessary for
compliance, now is the time to submit an
application to DOH for a temporary exemption,
which are granted based on economic hardship,
technical limitations or exceptional circumstances.
DOH may approve an exemption for a specified
amount of time, not to exceed one year from the
date of approval. The exception may be renewed
annually, subject to approval.
PDA is your advocate on all legislative and regulatory
issues! We asked the Department of Health (DOH)
to consider exempting providers who prescribe
a small number of prescriptions each year. Though
this is not in the law, DOH indicated it would take
this into consideration when reviewing applications
for a temporary exemption from the new law. If you
prescribe a small number of controlled substances
each year, be sure to include that in your application
for a temporary exemption. To apply for a temporary
exemption, log on to DOH’s website at https://
expressforms.pa.gov/apps/pa/health/Act96-of-
2018-Temporary-Exemption.
DOH may approve an exemption for a specified
amount of time, not to exceed one year from the
date of approval. The exception may be renewed
annually, subject to approval.
PDA recommends that providers still take steps
necessary to comply with Act 96 even when petitioning
DOH for a hardship exception.
PENALTIES
Providers who violate the Act are subject to the
following penalties:
l An administrative penalty of $100 for the first ten
violations.
l An administrative penalty of $250 for each
subsequent violation, up to a maximum of $5,000
per calendar year.
l Violations will reset and not carry over to
subsequent calendar years.
DOH will NOT report violations to the provider’s
licensing board, nor does the provider need to
self-report any violations. Licensing boards will
NOT take disciplinary actions for any violations of
Act 96 of 2018. Providers will have the ability to
appeal any fine assessed by DOH.
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