Oregon Board of Pharmacy
Fiscal Impact Request
Interested Parties:
The Board is seeking stakeholder input on the estimated fiscal impact (impact = projected costs – projected revenue/savings) associated with implementation, operation and ongoing compliance related to proposed amendments to current rules on compounding sterile and non-sterile preparations. We understand that some information you may want to provide could be proprietary; therefore, please note that any information provided becomes a public record. These rules apply to the preparation and dispensing of compounded drugs from a Drug Outlet. These rules do not apply to the preparation and direct administration of compounded drugs by a healthcare provider.
Fiscal information on any aspect of the request is appreciated. While overall fiscal impact is helpful, fiscal impact per line item is most helpful. Please reply to pharmacy.rulemaking@bop.oregon.gov by 4:30PM on August 10, 2023.
Additional opportunity to provide fiscal impact information is available when proposed rules are noticed for rulemaking during the public comment period.
Please provide an estimate of the fiscal impact associated with compliance, implementation and operation related to any of the following proposed rules:
1. Requiring all drug outlets that compound preparations to comply with Board compounding rules. Note: Proposed rules clarify that ‘drug outlet’ includes all Pharmacies, Dispensing Practitioner Drug Outlets (DPDOs), Correctional Facilities (CFs), and Community Health Clinics (CHCs).
2. Updating processes and facilities to comply with changes from the currently required USP standards in OAR 855-045-0200(3) to the new standards:
- USP <795> Pharmaceutical Compounding- Non-Sterile Preparations (11/01/2022) and all chapters referenced therein
- USP <797> Pharmaceutical Compounding—Sterile Preparations (11/01/2022) and all chapters referenced therein
3. Ensuring the environmental control, stability, and sterility of all compounded preparations shipped or delivered to a patient or patient’s agent in appropriate temperature-controlled delivery containers and stored appropriately according to USP <659> Packaging and Storage Requirements (04/01/2021).
4. Requiring the compounding area for compounded non-sterile preparations (CNSP) to have a visible line of demarcation.
5. Prohibiting carpet in the compounding area.
6. Requiring each compounded non-sterile preparation (CNSP) and compounded sterile preparation (CSP) to be labeled with:
- Indication that the preparation is compounded; and
- The facility name and contact information if the preparation is sent outside the facility or healthcare system in which it was compounded.
7. Establishing a continuous quality assurance program and quality controls.
8. Establishing a complaint handling process and an adverse event and error reporting process.
9. Establishing a recall procedure that requires the drug outlet to immediately issue a recall and immediately initiate communication with each recipient Drug Outlet, prescriber and patient receiving the recalled drug that was dispensed or intended for use in this state and document each attempt.
- Requiring the Initial communication to be completed:
(1) Within 12 hours of the recall if use or exposure to the recalled compounded drug will cause serious adverse health consequences or death. If confirmation the recipient received the communication cannot be established within this timeframe, the outlet must make two additional attempts to provide communication within 24 hours of the initial attempt.
(2) Within 36 hours of the recall if use or exposure to the recalled compounded drug might cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. If confirmation the recipient received the communication cannot be established within this timeframe, the outlet must make two additional attempts to provide communication within 24 hours of the initial attempt.
(3) If the recalled drug is not likely to cause adverse health consequences, the recipient Drug Outlet, prescriber or patient receiving the recalled drug that was dispensed or intended for use in this state, must be notified within 72 hours of the recall and the pharmacy must document the notification.
- Requires the recall procedure to ensure if all attempts to inform the recipient are unsuccessful in (1) and (2), the outlet must send notification via certified mail.
- Requires a Drug Outlet Pharmacy, DPDO, CF or CHC that has been advised that a patient has been harmed by using a compounded product potentially attributable to the outlet must report the event to MedWatch within 72 hours of the outlet being advised.
- Requires board to be notified of a recall in (1) on a form provided by the board within 10 business days of issuing the recall.
10. Permitting a drug outlet to regularly compound or compound inordinate amounts of an approved drug if the outlet is unable to obtain an adequate supply to regularly meet patient need of the approved drug from a Wholesale Distributor Drug Outlet.
11. Permitting a Drug Outlet Pharmacy to compound drugs for animal use that are not patient-specific. These non-patient-specific compounds will be limited to a 120-hour supply.
12. Ensuring all compounding utilizes a system that incorporates barcoding to verify ingredients. Please identify if there is an additional or decreased cost to implement this requirement in 2-5 years.
13. Requiring all drug outlets that compound sterile preparations from non-sterile ingredients to achieve accreditation/certification as listed below. Please identify if there is an additional or decreased cost to implement this requirement in 2-5 years.
- Compounding Pharmacy Accreditation through the Pharmacy Compounding Accreditation Board (PCAB) provided by the Accreditation Commission for Health Care (ACHC);
- Compounding Pharmacy Accreditation through the National Association of Boards of Pharmacy (NABP); or
- Medication Compounding Certification through The Joint Commission.
Thank you,
Rulemaking Staff
Oregon Board of Pharmacy
pharmacy.rulemaking@bop.oregon.gov
(971) 673-0001 phone
www.oregon.gov/pharmacy
The Oregon Board of Pharmacy serves to promote and protect public health,
safety and welfare by ensuring high standards in the practice of pharmacy and through effective regulation of the manufacture and distribution of drugs.
oregon.gov/pharmacy
The Oregon Board of Pharmacy is an equal opportunity, affirmative action employer committed to a diverse work force.
We respect, reflect and respond to the diverse people we serve.
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