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General Q&A
What is a Prescription Drug Monitoring Program (PDMP)?
The PDMP is a statewide program that collects information about controlled substance prescription drugs that are dispensed to patients within the state.
Why does Pennsylvania have a PDMP?
The Office of the Attorney General (OAG) operated the former PDMP. Previously, the PDMP required the reporting of Schedule II controlled substances only. The legislature passed a new law, Act 191 of 2014, which requires monitoring Schedule II through Schedule V controlled substances. The Pennsylvania Department of Health is responsible for the development and the day-to-day operations of the new system.
Do other states have PDMPs?
All 50 states have an operational prescription drug monitoring program or have enacted legislation to establish a PDMP and are in the process of creating one.
Does Act 191 of 2014 require prescribers or dispensers to search other state or territory’s PDMPs?
While Act 191 of 2014 includes requirements for prescribers and dispensers providing care in Pennsylvania to check the Pennsylvania PDMP in certain situations, the Act does not include requirements for prescribers and dispensers providing care in Pennsylvania to search other state or territory’s PDMPs.
The Pennsylvania Department of Health supports interstate data sharing and encourages providers to use their best judgment in determining if searching a PDMP in another jurisdiction is necessary or relevant. It is important for providers to be aware that there can be multiple patients who have the same name and date of birth and the likelihood of encountering two patients with the same name and date of birth increases as searches are expanded to include additional states or territories. As a result, multiple patients with the same name and date of birth, but different addresses, may be displayed, making it appears as if a patient is receiving multiple prescriptions. When checking other state’s systems, additional independent verification of patient profile information with pharmacies and prescribers may be prudent or necessary.
What is the purpose of the PDMP?
The purpose of the PDMP established by Act 191 of 2014 is two fold:
- To be used as a tool to increase the quality of patient care by giving prescribers and dispensers access to a patient's controlled substance prescription medication history, which will alert medical professionals to potential dangers for purposes of making treatment determinations; and
- To aid regulatory and law enforcement agencies in the detection and prevention of fraud, drug abuse and the criminal diversion of controlled substances.
How does the PDMP work?
As of January 1, 2017, dispensers are required to collect and submit dispensation information to the PDMP no later than the close of the subsequent business day. The PDMP stores the information in a secure database and makes it available to healthcare professionals and others as authorized by law.
When will prescribers and dispensers have access to the PA PDMP database?
Registration for PA PDMP program is open and the system is available for query.
What are controlled substances?
Controlled substances are drugs that have varying degrees of potential for abuse or dependence. Drugs and other substances that are considered controlled substances under the Controlled Substances Act (CSA) are divided into five schedules. Substances are placed in their respective schedules based on whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and likelihood of causing dependence when abused. The following are examples of Schedule II through Schedule V controlled substances:
- Schedule II - drugs with acceptable medical use, but with a high abuse potential that lead to dependence (morphine, methadone, oxycodone).
- Schedule III - drugs with less abuse potential and a moderate risk of abuse potential (aspirin/codeine combinations, buprenorphine).
- Schedule IV - drugs with a lower abuse potential (alprazolam, clonazepam, diazepam).
- Schedule V - drugs with less abuse potential than other schedule drugs and contain limited quantities of a controlled substance (Robitussin AC, Phenergan with codeine).
If you would like to look up whether a specific substance is controlled, you can use the following lists:
- DEA: List of controlled substances in alphabetic order (PDF)
- CDC Table: Morphine milligram equivalent doses for commonly prescribed pain management
- Pennsylvania Controlled Substance, Drug, Device and Cosmetic Act (PDF)
Are non-controlled substance medications reported to the PA PDMP?
Dispensations of medications that are not classified as Schedule II-V by either Pennsylvania or Federal law are not required to be submitted to the PA PDMP. However, dispensers who submit data to the PA PDMP may also report dispensations to other states that require dispensations of non-federally scheduled drugs to be reported to their PDMP systems, as Pennsylvania does with barbiturates and barbiturate derivatives. As a result, those dispensers, pharmacies, and/or software vendors may submit dispensation data to Pennsylvania's PDMP that is not required by PA State Act 191 of 2014.
If a non-controlled substance is present on one patient's Prescription Report, it should not be assumed that this same medication will be reported on another patient's Prescription Report. Providers and dispensers should continue to utilize their professional judgment when making prescribing or dispensing decisions based on information in the PA PDMP.
Will there be a training program for dispensers and prescribers to utilize the system?
Videos and guides on how to register, search, and use the new PDMP system are available on the PDMP website. Log onto the website, scroll to the bottom of the page, and click on “Guides” under the Help section. Instructional videos are available under the “Video” tab, and user guides are available under the “Documents” tab. Additionally, Page Walkthrough buttons can be found on the top-right of the page, and these can guide users through each page’s functionality.
What is required of dispensers?
As of January 1, 2017, all Schedule II-V dispensed prescriptions must be reported to the system no later than the close of the subsequent business day.
For example, if your pharmacy is open Monday to Friday, from 8:30 a.m. to 9:00 p.m., the dispensation data from Monday must be submitted by Tuesday before 9:00 p.m. The dispensation data from Friday must be submitted by the following Monday before 9:00 p.m.
Note: The PA PDMP system can accept dispensation data every day, including weekends.
What should I do if there is incorrect information in the PA PDMP system?
This answer varies depending on if you are the patient, a provider, or a pharmacy/dispensing practitioner. Providers should review the Prescriber Q&A, and pharmacies/dispensing practitioners should review the Dispenser Q&A.
Patients: If you were notified that there are records belonging to a patient that is not you on your PDMP report, please either have your provider call the pharmacy or contact the pharmacy yourself to request that they correct their records.
If the pharmacy or dispensing practitioner does not correct the records, patients may view their PDMP reports by filling out the Patient Prescription Record Request form and mailing or emailing the form to the Pennsylvania Prescription Drug Monitoring Program office. Once the patient has received their PDMP records, they can then submit a Patient Prescription Record Correction Request form, noting exact prescription information as shown on the PDMP report and detailing that the pharmacy has been contacted but records have not been corrected.
Must military bases and/or military pharmacies submit controlled substance dispensations to the Pennsylvania PDMP?
Act 191 of 2014 and the PA Pharmacy Act define pharmacy as a location “issued a permit by the Board of Pharmacy” - military pharmacies are not licensed by the state board of pharmacy and are a separate federal entity, therefore their controlled substance dispensations are not required per Act 191 of 2014. However, if a dispenser and/or data submitter from a military pharmacy is registered with the Pennsylvania PDMP system, Act 191 of 2014 does not prevent submission of their controlled substance dispensations to the Pennsylvania PDMP. You may refer to Pennsylvania’s ABC-MAP Act of 2014 for state-specific requirements for dispensers, pharmacies, and prescribers.
The Military Health System has their own system for tracking controlled substance dispensations and the PA PDMP integrates with MHS’s system. For more information about integration and how to search the MHS and other states, please visit: Interstate | Department of Health | Commonwealth of Pennsylvania or MHS’s PDMP FAQ website.
Are dispensers or data submitters permitted to report dispensations to the Pennsylvania PDMP that are not required to be reported?
PA State Law Act 191 of 2014 requires that, as of January 1, 2017, pharmacies and dispensing practitioners submit all controlled substance (Schedule II-V) dispensation information to the PDMP system no later than the close of the subsequent business day after dispensing a controlled substance.
PA state law does not explicitly prohibit the voluntary submission of non-controlled substance dispensation data to the PA PDMP.
Will the new PDMP system be "real-time"?
Dispensers, prescribers, and their delegates will have "real-time" access to the data stored by the PDMP at any given time. However, as of January 1, 2017, data submitters have until the close of the subsequent business day to submit data after dispensing a scheduled prescription drug.
Do dispensers or prescribers have to pay anything for the program?
A dispenser or prescriber shall not be required to pay a fee or tax specifically dedicated to the establishment, operation, or maintenance of the program.
Will the PDMP offer any kind of referrals to treatment programs for patients suspected to have the disease of addiction?
The PDMP provides data to healthcare professionals to enable them to make more informed decisions about prescribing and dispensing monitored prescription drugs to their patients or potential patients. Healthcare professionals are encouraged to use the data obtained from the PDMP to improve their treatment of patients, including referring patients to substance use treatment. Information regarding drug and alcohol treatment services is available on the Pennsylvania Department of Drug and Alcohol Programs website.
What are the definitions for, administer, dispense, prescribe, and prescription?
A: “Administer” means the direct introduction of or the application of a drug into or on the body of a patient by injection, inhalation, ingestion or any other means and, where required by law, shall occur only pursuant to a medical order. (PA. Pharmacy Act, section 2-16 added June 29, 2002, P.L.673, No.102)
“Dispense" means to deliver a controlled substance, other drug or device to a patient by or pursuant to the lawful order of a prescriber. (ABC-MAP Act of 2014, P.L. 2911, No. 191, Section 3).
“Prescribe” means the issuance of a prescription by a duly licensed medical practitioner authorized by law to prescribe drugs. (See “prescription”).
“Prescription” means a written or oral order issued by a duly licensed medical practitioner in the course of his or her professional practice for a controlled substance which is dispensed for use by a consumer. PA. (Pharmacy Act, Section 2-8 added June 29, 2002, P.L.673, No.102)
Have there been recent changes to the PA PDMP Patient Prescription Report?
The Pennsylvania Prescription Drug Monitoring Program (PDMP) is constantly striving to enhance the information available to PDMP users. In December 2023, the disclaimer at the bottom of every Patient Prescription Report was revised. The new disclaimer reads as follows:
Information from the Pennsylvania Prescription Drug Monitoring Program (PDMP) database is protected health information and any information accessed must be treated as confidential. Any person who knowingly or intentionally makes an unauthorized disclosure of information from the PDMP database will be subject to civil and criminal penalties as set forth in the ABC-MAP Act 191 of 2014; Act of Oct. 27, 2014, P.L. 2911, No. 191.
The information in the PDMP database is submitted by pharmacies and may contain errors and omissions. Additionally, pharmacies may submit extraneous non-controlled substance dispensations to the PDMP database; if a non-controlled substance is present on one patient's Prescription Report, it should not be assumed that this same medication will be reported on another patient's Prescription Report. Independent verification of prescription information with pharmacies and prescribers may sometimes be prudent or necessary.
Prescriber Q&A
How does the PDMP legislation define prescriber?
According to Act 191 of 2014, a prescriber is a person who is licensed, registered or otherwise lawfully authorized to distribute, dispense or administer a controlled substance, other drug or device in the course of professional practice or research in this Commonwealth. The term does not include a veterinarian.
If I don't prescribe any controlled substances, do I need to register for the program?
As of January 1, 2017, all licensed prescribers who are lawfully authorized to distribute, dispense, or administer a controlled substance in the Commonwealth of Pennsylvania are required to register with the program. This does not include veterinarians.
If I am licensed in Pennsylvania but do not practice in Pennsylvania, do I need to register for the program?
Yes. As of January 1, 2017, all licensed prescribers who are lawfully authorized to distribute, dispense, or administer a controlled substance in the Commonwealth of Pennsylvania are required to register with the program. This does not include veterinarians.
If I am a retired prescriber, do I need to register for the program?
As of January 1, 2017, all licensed prescribers who are lawfully authorized to distribute, dispense, or administer a controlled substance in the Commonwealth of Pennsylvania are required to register with the program. If you do not have an active license, you do not need to register.
What are the requirements for prescribers regarding the use of the PA PDMP?
Per Act 191 of 2014, lawfully authorized prescribers are required to query the PDMP for an existing patient when the following clinical situations apply:
- For each patient the first time the patient is prescribed a controlled substance by the prescriber for purposes of establishing a baseline and a thorough medical record; or
- If a prescriber believes or has reason to believe, using sound clinical judgment, that a patient may be abusing or diverting drugs; or
- Each time a patient is prescribed an opioid drug product or benzodiazepine by the prescriber.
These requirements apply: to inpatient or outpatient settings; to acute or anticipated chronic controlled substance(s) prescriptions; to new or established patients; and in situations where the prescriber is seeing his/her own patient or is covering for a colleague. Writing a controlled substance prescription for the first time to a patient is the basis for checking the PDMP as detailed in the first clinical situation above.
However, as part of good clinical practice, the Department of Health recommends that health care professionals check the system every time before a controlled substance is prescribed or dispensed in any clinical setting.
Are prescribers required to check the PDMP when providing care in emergency departments?
No. Checking the PDMP is not required for any medication provided to a patient in the course of treatment while undergoing care in an emergency department. This exception does not apply to patients undergoing care in urgent care centers or when in observation status in a health care facility. If a medication prescription is issued during discharge, then the PDMP system must be queried. As part of good clinical practice, the Department of Health recommends that health care professionals check the system every time before a controlled substance is prescribed or dispensed in any clinical setting.
Does the PDMP need to be queried before prescribing a controlled substance to a patient who is admitted to a health care facility?
The PDMP system must be queried at least once from the time of admission through discharge when a patient is prescribed a controlled substance, as required by law. Beyond the initial query, additional queries of the system are not required as long as the patient remains admitted to the licensed health care facility or remains in observation status in a licensed health care facility. The Department of Health recommends that health care facilities develop a process by which documentation is made in the clinical record so that the care team knows an initial query has been made and does not need to be repeat the querying process.
When do prescribers need to query the system if they issue controlled substance prescriptions dated in the future?
Prescribers should query the system at the time the prescriptions are issued to the patient.
Do prescribers need to query the PDMP system every time they prescribe a new controlled substance medication for a patient?
Yes, if it's a new prescription for that patient, the prescriber is required to check the PA PDMP system.
If a prescriber is switching a patient's controlled substance medication to a different but similar one, does the prescriber need to query the system?
Yes, if it's a new prescription for that patient, the prescriber should check the PA PDMP system.
Do prescribers need to query the PDMP system every time they prescribe an opioid or benzodiazepine, even if the patient has signed a controlled substance agreement in clinic and is seen regularly?
Yes. As of January 1, 2017, each time a patient is prescribed an opioid or a benzodiazepine, the PDMP is required to be queried.
Are prescribers required to query the PDMP system when prescribing a dosage change or refill for an opioid or benzodiazepine?
Yes. As of January 1, 2017, each time a patient is prescribed an opioid or a benzodiazepine, the PA PDMP system is required to be queried.
Are prescribers required to query the PA PDMP system when prescribing a dosage change or refill for a controlled substance other than an opioid or benzodiazepine?
No. Query is not required when prescribing a dosage change or refill of non-opioid, non-benzodiazepine controlled substances previously prescribed to the patient by the prescriber.
Does a prescriber need to record information from the PA PDMP system into the electronic medical record?
Yes, there are two situations in which a prescriber needs to record information from the PA PDMP system into the medical record. Act 191 of 2014 states that a prescriber shall indicate the information obtained from the system in the patient's medical record if:
- The individual is a new patient; or
- The prescriber determines a drug should not be prescribed or furnished to a patient based upon the information from the system.
This documentation could be as simple as one of the following examples:
- "Checked the PA PDMP; no red flags identified; safe to proceed with prescription"
- "Checked the PA PDMP; opted not to prescribe a narcotic after determining patient had filled six prescriptions from four different prescribers over the past five weeks. Discussed findings with patient."
As a physician, do I need to input any information into the PA PDMP system?
If you are a dispensing physician, you are considered a dispenser and are required to submit your dispensation data to the PA PDMP system. Physicians who do not dispense controlled substances themselves do not need to input any information into the PA PDMP system.
What should I do if there is incorrect information in the PA PDMP system?
The information presented on the Pennsylvania PDMP reflects prescription data provided by the pharmacy or dispensing practitioner that dispensed the patient’s prescription. As a result, there are times when discrepancies may occur. In the event that an error is identified by a PDMP system user, the user should contact the pharmacy or dispensing practitioner that dispensed the prescription to attempt to correct the error. Pharmacies are required to submit accurate prescription information and should correct the information as quickly as possible.
If the pharmacy or dispensing practitioner does not correct the records, prescribers may:
- Log into the PA PDMP, scroll down to the “Help” section, and select “Technical Support” to open a support ticket
- Email papdmp@logicoy.com directly to report the issue and open a support ticket
- Go to the Patient Information page on the PA DOH website, download the Patient Prescription Correction Request form, fill it out completely, and mail or email the filled-out document to the PDMP office.
As a prescriber, if I dispense a controlled substance sample to a patient for them to self-administer, do I need to report it to the PA PDMP?
Yes. If you dispense a controlled substance sample, it must be reported to the Pennsylvania PDMP system. Controlled substance samples fall under the same requirements as all other controlled substance dispensations.
What is the level of liability on a prescriber if they make a clinical decision to issue or not issue an opioid based on the data in the PDMP?
A prescriber who received information from the system in accordance with Act 191 Sections 7, 8, and 9 shall not be held civilly liable for not seeking or obtaining information from the system prior to prescribing a controlled substance. Accessing the system does not insulate healthcare professionals from medical malpractice claims simply because they access the system. Prescribers still must use sound clinical judgment in making treatment decisions. The system is simply another tool, just like attending conferences on particular areas of practice or reading current journals, etc. If prescribers make a clinical decision that causes harm, they will be subject to the same practice/malpractice standards as any practitioner would be in any other circumstance
What happens if prescribers improperly use or fail to check the system when making a clinical decision about prescribing a controlled substance?
If prescribers improperly use the system, including knowingly or intentionally obtaining information for purposes other than for treatment or dispensation of controlled substances, they are subject to civil and/or criminal penalties. Failure to comply with the mandates set forth in Act 191 of 2014 could result in disciplinary action against one's professional license. Disciplinary actions of professional licenses fall under the purview of the Department of State.
Before a prescriber or delegate searches a patient's controlled substance prescription history on the PDMP system, do they need to get patient consent?
No. Authorized users of the PA PDMP system do not need to obtain patient consent prior to querying the system.
Do anesthesiologists need to query the PA PDMP system prior to administering anesthesia?
An anesthesiologist providing professional health care services within a health care facility who orders a controlled substance dispensed for immediate administration is not required to query the system as long as the PDMP system was queried at least once since the time of admission. A surgical patient may be queried by a delegate of the anesthesiologist, for instance, by a nurse at the time of admission. Beyond the initial query, additional queries of the system are not required as long as the patient remains admitted to the licensed health care facility or remains in observation status in a licensed health care facility. The Pennsylvania Department of Health recommends that health care facilities develop a process by which documentation is made in the patient record so that the care team knows an initial query has been made and does not have to repeat the querying process.
Are prescribers required to query the PDMP when prescribing for the treatment of epilepsy or a seizure disorder?
Effective February 22, 2018, prescribers are not required to query the PDMP when prescribing a non-narcotic Schedule V controlled substance for the treatment of epilepsy or a seizure disorder. This exception does not apply to the prescribing of other controlled substances, regardless of treatment purpose. For example: if you are prescribing Schedule V controlled substances for the first time to your patient for conditions other than epilepsy or a seizure disorder, then a query is required.
Dispenser Q&A
How does the PDMP legislation define dispenser?
According to Act 191 of 2014, a dispenser is a person licensed to dispense in this Commonwealth, including mail order and internet sales of pharmaceuticals.
This term does not include any of the following:
- A licensed health care facility that distributes the controlled substance for the purpose of administration in the licensed health care facility.
- A correctional facility or its contractors if the confined person cannot lawfully visit a prescriber outside the correctional facility without being escorted by a corrections officer.
- An authorized person who administers a controlled substance, other drug or device.
- A wholesale distributor of a controlled substance.
- A licensed provider in the LIFE program.
- A provider of hospice as defined in the act of July 19, 1979 (P.L.130, No.48), known as the Health Care Facilities Act.
- A prescriber at a licensed health care facility if the quantity of controlled substances dispensed is limited to an amount adequate to treat the patient for a maximum of five days and does not allow for a refill.
- A veterinarian.
Are dispensers required to register for the program?
As of January 1, 2017, all individuals lawfully authorized to dispense in the Commonwealth of Pennsylvania, including mail order and internet sales of pharmaceuticals, must register with the program.
In which circumstances can dispensers query the PDMP?
Lawfully authorized dispensers may query the PDMP for a current patient to whom the dispenser is dispensing or considering dispensing any controlled substance.
Are dispensers required to query the PDMP?
Yes. As of January 1, 2017, all dispensers licensed in the Commonwealth of Pennsylvania shall query the PDMP before dispensing an opioid drug product or a benzodiazepine prescribed to a patient if any of the following apply:
- The patient is a new patient of the dispenser.
- The patient pays cash when they have insurance.
- The patient requests a refill early.
- The patient is getting opioid drug products or benzodiazepines from more than one prescriber.
A new patient does not include an individual going to the same pharmacy, or a different physical location of that pharmacy, if the patient's record is available to the dispenser. Cash refers to any non-insurance payment, excluding copays. Early refill is defined as when the patient requests a refill prior to the date when they are eligible for insurance coverage for the prescription, or when more than 15 percent of an earlier-dispensed medication would remain when taken in compliance with the directions and quantity prescribed. Dispensers must query the PDMP if they have reason to believe the patient is getting opioid drug products or benzodiazepines from more than one prescriber.
Who must report dispensation data to the PDMP and how frequently?
Pharmacies and dispensing prescribers must submit all controlled substance (Schedules II–V) dispensation information to the PDMP system no later than the close of the subsequent business day after dispensing a controlled substance. A business day is any day within the standard five-day business week beginning on Monday and ending on Friday. Dispensers are encouraged to submit every day as well as on weekends if they are open for business.
What medications are required to be reported to the Pennsylvania PDMP?
PA State Act 191 of 2014, also known as the ABC-MAP Act, requires pharmacies and dispensing practitioners (dispensers) to report all Federal and Pennsylvania Schedule II-V controlled substance dispensations to the PDMP.
If a dispenser does not dispense any controlled substances on a business day, do they need to submit a zero-report?
Yes, dispensers must submit a zero-report to notify the PDMP office that they did not dispense any controlled substances on a given business day. In certain circumstances, the PDMP office will grant dispensers a waiver from submitting zero-reports – for instance, if a pharmacy never dispenses controlled substances or dispenses less than 5 controlled substances per month. The zero-report waiver application is available here.
Do dispensers need to report the date the prescription was filled or the date it was picked up?
If a dispenser has the date the prescription was sold or picked up, then they must report that. This is only possible if the pharmacy has a point-of-sale system that is integrated with the pharmacy management system to allow a bidirectional flow of information. If the date the prescription sold is not available, submitting the date it was filled is sufficient.
Are dispensers required to report the National Provider Identifier (NPI) number of the pharmacist?
No. However, dispensers are required to submit both the NPI and Drug Enforcement Administration (DEA) number of the pharmacy.
Are dispensers required to collect identification (ID) from patients when they pick up or drop off prescriptions and report that to the PDMP?
No, collecting patient ID information is not legally required at this time. However, dispensers are permitted to collect IDs from patients if they so choose.
What should I do if there is incorrect information in the PA PDMP system?
For information on how to submit corrections for controlled substance dispensations, pharmacies and dispensing practitioners should first reference the Data Submitter Guide, found after logging into the PA PDMP system under the “Help” section. If questions or concerns remain after reviewing the Data Submitter Guide, pharmacies and dispensing practitioners may contact the PA PDMP at: 1-844-377-7367, selecting option “0” on Monday through Friday from 8:00 a.m. to 4:00 p.m. EST or by emailing a detailed request to ra-dh-pdmp@pa.gov.
When the prescription is for an animal, whose name and address should be submitted?
When dispensing to veterinary patients, the owner's information should be collected and submitted to the PDMP. Additionally, field PAT20 should indicate "Veterinary Patient" and field PAT23 should indicate the name of the animal. Please consult the LogiCoy data submission guide for more information on the necessary data fields. Visit pdmp.health.pa.gov and select “Training Resources” at the bottom of the page to view information about data submission. You may also view the data submission guide by logging into the PDMP, selecting “Training Resources”, and then selecting “Documents” to view the guide.
How should partial fills be reported?
Partial fills can be indicated using field DSP13. The first partial fill is indicated as 01 and each subsequent fill should increase by 1. Please consult the LogiCoy data submission guide for more information on the necessary data fields. Visit pdmp.health.pa.gov and select “Reference Guides” at the bottom of the page to view information about data submission. You may also view the data submission guide by logging into the PDMP, selecting “Guides” under the Help section, and selecting the “Documents” tab.
Does Fioricet (butalbital/caffeine/acetaminophen) need to be reported to the PDMP?
Yes. Although Fioricet (butalbital/caffeine/acetaminophen) is not scheduled federally, Pennsylvania state law schedules barbiturates and barbiturate derivatives as Schedule III. Fioricet contains a barbiturate, and is therefore considered a Schedule III controlled substance under Pennsylvania state law. The PDMP requires reporting of all Schedule II-V controlled substance prescriptions.
Now that Xylazine is a Schedule III drug in PA, does it need to be reported to the PDMP?
No, xylazine does not need to be reported to the PDMP. Xylazine is only approved for veterinary use. The recent scheduling of xylazine as a Schedule III drug does not pertain to veterinarian dispensations, prescriptions, or administrations of drugs containing xylazine. Therefore, dispensations, prescriptions, or administrations of drugs containing xylazine to non-human species are not reported to the PA PDMP.
Pennsylvania's Department of Health issued a final order on June 3, 2023, temporarily scheduling xylazine as a Schedule III substance, which was not previously listed in any schedule of The Controlled Substance, Drug, Device and Cosmetic Act (35 P.S. §§ 780-101—780-144), subject to the limitations outlined in the final order. Although approved only for veterinary use, Xylazine is a nonopioid with an increasing presence as an adulterant, often in combination with opioids, in the illicit drug supply. Accordingly, Xylazine was added as a Schedule III substance except when it is used in any of the following manners:
- Dispensing or prescribing for, or administration to, a nonhuman species of a drug containing xylazine that has been approved by the Secretary of Health and Human Services under section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. § 360b).
- Dispensing or prescribing for, or administration to, a nonhuman species that is permission under section 512(a)(4) of The Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. § 360b(a)(4)).
- The manufacturing, distribution, or use of xylazine as an active pharmaceutical ingredient for manufacturing an animal drug approved under section 512 of The Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. § 360b or issued an investigation use exemption under subsection (j) of § 512.)
- The manufacturing, distribution or use of a xylazine bulk chemical for pharmaceutical compounding by licensed pharmacists or veterinarians.
- Another use approved or permissible under The Federal Food, Drug, and Cosmetic Act.