DA - Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding
Learn more about the coronavirus (COVID-19) outbreak.
Information for telemedicine during the coronavirus emergency.
Message from DEA regarding COVID-19 (PDF)
Targeted Distribution of PPE
On April 8, 2020, Governor Wolf Signed an order to provide targeted distribution of COVID-19 PPE and supplies to hospitals. The order requires private, public and quasi-public health care providers and facilities submit current inventory quantities of PPE, pharmaceuticals and other medical resources to PEMA by April 16, 2020. The survey link can be accessed hereOpens In A New Window.
Additionally, a FAQ regarding this topic can be found here..
State Board of Pharmacy
The Bureau of Professional and Occupational Affairs (BPOA) received reports that a person pretending to be from the State Board of Pharmacy (Board) is calling licensees about the status of their license. The scammer asks for credit card information. Persons who give their credit card information may not only lose their money, but also can become a victim of identity theft.
Licensees are urged to avoid becoming a victim of credit card fraud or identity theft:
BPOA and/or Board will NOT call licensees asking for payment over the phone.
If you get a text message or call asking for your credit card information, hang up.
Do NOT give your personal or financial information over the phone.
If you feel that you are a victim of any type of scam, you should immediately notify your local or state police.
Warning: New Scheme Being Perpetrated
It has come to the Pennsylvania State Board of Pharmacy’s (Board’s) attention that a new scheme regarding product ordering/recall fraud incidents is being perpetrated against pharmacies.
Some details regarding the schemes include:
- The perpetrators continue to convince distribution representatives (both in wholesale and retail environments, as well as over the phone and electronically) that they are making legitimate inquiries about drug shipments.
- The credentials the perpetrators are supplying are real, having obtained them through a variety of social engineering techniques.
- A fair number of retail pharmacies are now receiving telephone calls from individuals identifying themselves as being from a state board of pharmacy or a state health department. In these scenarios, the person calling (who is almost always female) asks the pharmacy representative for specific routine and disarming information, such as address, hours of operation, phone numbers, principal contacts, etc.
- The names used by the female callers to identify themselves include “Julie McNeil,” “Cynthia,” “Beth,” “Beth Walton,” and “Danielle.”
- The caller eventually asks questions about the names of the pharmacy’s primary and secondary wholesalers, the type(s) and cadence of their business interactions with their wholesalers, and, in some instances, account numbers.
- On some calls, the perpetrator uses the excuse that the board of pharmacy needs such information because it is responsible for notifications of recalls.
This type of probe is an initial form of social engineering that gives the perpetrators what they need to take their inquiries to the next level. If they are unable to get the information they want during the initial call, they will use what they learned to impersonate the pharmacy’s principal distributor (because they now know who it is) in a subsequent call to again try to elicit account numbers and passwords.
Please note that the Board of Pharmacy office staff will not contact pharmacies to request information on the pharmacy’s distributors or wholesalers. Keep in mind that individuals have been known to spoof the Board of Pharmacy’s phone number in order to appear to be calling from the Board office when they are, in fact, calling from a different phone number.
Announcement for Pharmacist License Applicants
At the June 28, 2018
Pennsylvania State Board of Pharmacy (Board) Meeting, the Board voted to waive
the requirement that Pharm.D. graduates of schools of pharmacy accredited by
the Accreditation Council for Pharmacy Education (ACPE) earn at least 500
intern hours outside of their academic program. This means that the 1,500
intern hours required for licensure as a pharmacist may be earned through an
ACPE-accredited school of pharmacy’s Pharm.D. program and these graduates are
no longer required to earn 500 intern hours outside of the school’s academic
United States Pharmacopoeia (USP) (Rev. 12/19)
At the October 22, 2019 Pennsylvania State Board of Pharmacy (Board) Meeting, the Board discussed issues related to USP’s decision to delay implementation of the revisions to chapters 795 and 797 pending resolution of appeals. The following decisions were approved by the Board and placed on record:
- The Board is enforcing USP 795 and 797 as currently written. Board Regulation Section 27.601 was finalized on June 22, 2019 and requires compliance with section 503a of the federal Food, Drug and Cosmetic Act, federal regulations promulgated thereunder and the current version of the USP chapters governing compounding.
- The Board is delaying the enforcement of USP 800 until the appeals of certain provisions of the revised USP 795 and 797 are resolved. While enforcement of USP 800 is being delayed, pharmacies should do their best to comply with the requirements of USP 800, including the sections related to the handling of hazardous medications, as these requirements will be enforced at some time in the future, dependent on resolution of the appeals of the revised USP 795 and 797.
The Board voted to adopt the following position and will be amending its regulations to reflect this information:
The definition of "compounding" does not include the unencumbered flavoring of conventionally manufactured medications provided that the flavors used are inert, tested and do not alter a medication’s concentration beyond USP’s accepted level of variance.
Note: Please refer to the following links for additional information on USP 800 and its scope (i.e. it would be applicable only when a practitioner is engaged in compounding):
Please note that neither the Board/Commission, nor its staff or counsel, are permitted to provide legal advice or advisory opinions, including interpretations of the law or regulations, or any indication as to how the Board would vote on any given case or scenario. You are invited to contact a private attorney or professional organization for advice or guidance.