RULES AND REGULATIONS
Title 49--PROFESSIONAL AND VOCATIONAL STANDARDS
STATE BOARD OF PHARMACY
[49 PA. CODE CH. 27]
Reference Library and Facsimile Machines
[32 Pa.B. 1194] The State Board of Pharmacy (Board) amends §§ 27.14 and 27.20 (relating to supplies; and facsimile machines) to read as set forth in Annex A.
A. Effective Date
The amendments will be effective upon publication of the final-form regulations in the Pennsylvania Bulletin.
B. Statutory Authority
The final-form amendments are authorized under sections 4(j) and 6(k)(1) and (9) of the Pharmacy Act (63 P. S. §§ 390-4(j) and 390-6(k)(1) and (9)).
C. Background and Purpose
Section 27.14(c)(14) currently requires a pharmacy to have an adequate reference library including two or more of the latest editions of references specifically listed in the section. The final-form rulemaking amends this section by eliminating the specific list of references and replacing it with language that allows a pharmacy to maintain references which are more appropriate and necessary to that pharmacy's area of practice.
Section 27.20 allows a pharmacist to fill a prescription for a Schedule II controlled substance that is received on a facsimile machine under certain conditions. This section is consistent with Federal law with one exception. Federal law allows a pharmacist to use the facsimile prescription as the original prescription for all Schedule II controlled narcotic substances for hospice patients, while § 27.20 only allows a facsimile prescription as the original prescription for ''injectable'' Schedule II controlled substances for hospice patients. The final-form rulemaking amends this section and makes it consistent with Federal law.
D. Summary of Comments and Responses on Proposed Rulemaking
Notice of the proposed rulemaking was published at 31 Pa.B. 2480 (May 12, 2001). Publication was followed by a 30-day public comment period during which the Board received one public comment. Following the close of the public comment period, the Board received comments from the House Professional Licensure Committee (HPLC) and the Independent Regulatory Review Commission (IRRC). The Senate Consumer Protection and Professional Licensure Committee (SCP/PLC) did not comment. The following is a response to the comments.
Section 24.14. Supplies.
IRRC recommended that the Board consider deleting repeated references to the phrase ''an adequate reference library'' in this section for greater readability and less repetition. The Board agrees and has amended this section accordingly.
IRRC also commented that the phrase ''safe and effective manner'' used in subsection (c)(14)(iii)(A) was unclear and recommended that the Board include examples of what it considers ''a safe and effective manner.'' The intention underlying this final-form rulemaking was to ensure that pharmacists had reference materials that are applicable to their type of pharmacy practice (for example, nuclear pharmacy vs. family pharmacy). Therefore, the Board determined not to cite specific referenced volumes. To accommodate IRRC's concern, however, the Board has amended the language in an attempt to clarify what it meant with regard to this particular standard.
Section 27.20. Facsimile machines.
There were three comments regarding this section. First, HPLC, IRRC and Mr. Greene questioned the use of the phrase ''which will be administered to . . . '' in subsection (a)(2)(i) and (iii). IRRC questioned whether the Board intended to exclude self-administered medications, and if not, recommended that the Board replace the phrase with the phrase ''for the direct administration'' used in the Federal regulations. The HPLC noted Mr. Greene's comment that patients often self-administer their medications. Mr. Greene recommended eliminating the phrase ''which will be administered to'' and replacing it with the word ''for.'' The Board did not intend to exclude self-administration for hospice patients. Its intent is only to be consistent with Federal law. IRRC is correct that Federal law uses the phrase ''for the direct administration'' but this is in regard to prescriptions written for a Schedule II narcotic substance for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion. See 21 CFR 1306.11(e) (2000) (relating to requirement of prescriptions). Section 27.20(a)(2)(i) follows this Federal regulation and the Board has amended this subsection by deleting the phrase ''which will be administered to'' and replacing it with ''to be compounded for the direct administration'' so that it will now be consistent with the most current version of the Federal law. However, this phrase is not used with regard to prescriptions written for Schedule II narcotic substances for patients in a hospice program. Rather, 21 CFR 1306.11(g) (2000) uses the language recommended by Mr. Greene. Therefore, the Board has amended § 27.20(a)(2)(iii) eliminating the phrase ''which will be administered to'' and replacing it with the word ''for.'' Again, the Board's intent is to have the language in its regulation follow that of the Federal law.
Second, the HPLC noted Mr. Greene's comment that the term ''narcotic'' should be removed from subsection (a)(2)(i) and (iii) because corresponding Drug Enforcement Administration (DEA) regulations will be applicable to new, nonnarcotic Schedule II controlled substances. However, the Board is not aware of any DEA regulations eliminating the word ''narcotic.'' Rather, the most current version of 21 CFR 1306.11(e) and (g) (2000) still includes the word ''narcotic.'' The Board will not remove the word narcotic from these subsections unless the Federal law removes it.
Finally, the HPLC, IRRC and Mr. Greene recommended that the Board replace ''hospice patient'' in subsection (a)(2)(iii) with ''patient enrolled in a hospice care program'' to be consistent with the language in the Federal regulations. The Board agrees with this recommendation and has amended this subsection accordingly.
E. Compliance with Executive Order 1996-1, Regulatory Review and Promulgation
The Board reviewed this rulemaking and considered its purpose and likely impact on the public and the regulated population under the directives of Executive Order 1996-1, ''Regulatory Review and Promulgation.'' The final-form rulemaking addresses a compelling public interest as described in this Preamble and otherwise complies with Executive Order 1996-1.
F. Fiscal Impact and Paperwork Requirements
This final-form rulemaking will have no fiscal impact or impose any additional paperwork requirements on the Commonwealth or its political subdivisions. Additionally, the final-form rulemaking should not necessitate any legal, accounting or reporting requirements on the regulated community.
G. Sunset Date
The Board reviews the effectiveness of its regulations on an ongoing basis. Therefore no sunset date has been assigned.
H. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on May 12, 2001, the Board submitted a copy of the notice of proposed rulemaking published at 31 Pa.B. 2480 to IRRC and to Chairpersons of the SCP/PLC and the HPLC for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC, the SCP/PLC and the HPLC were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing this final-form rulemaking, the Board has considered the comments received from IRRC, the SCP/PLC, the HPLC and the public.
Under section 5.1(d) of the Regulatory Review Act (71 P. S. § 745.5a(d)), on December 26, 2001, this final-form rulemaking was deemed approved by the SCP/PLC and the HPLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on January 10, 2002, and approved the final-form rulemaking.
I. Contact Person
Further information may be obtained by contacting Melanie Zimmerman, Executive Secretary, State Board Pharmacy, P. O. Box 2649, Harrisburg, PA 17105-2649, (717) 783-7156, www.dos.state.pa.us.
J. Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations promulgated thereunder in 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) These final-form regulations do not enlarge the purpose of proposed rulemaking published at 31 Pa.B. 2480.
(4) These final-form regulations are necessary and appropriate for administration and enforcement of the authorizing acts identified in part B of this Preamble.
K. Order
The Board, acting under its authorizing statutes, orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 27, are amended by amending §§ 27.14 and 27.20 to read as set forth in Annex A.
(b) The Board shall submit this order and Annex A to the Office of General Counsel and to the Office of Attorney General as required by law.
(c) The Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(d) This order shall take effect on publication in the Pennsylvania Bulletin.
MICHAEL A. PODGURSKI, R.Ph.
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission, relating to this document, see 32 Pa.B. 477 (January 26, 2002).)
Fiscal Note: Fiscal Note 16A-549 remains valid for the final adoption of the subject regulations.
Annex A
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 27. STATE BOARD OF PHARMACY
STANDARDS § 27.14. Supplies.
(a) A pharmacy shall maintain a supply of drugs and devices adequate to meet the needs of the health professions and the patients it is intended to serve. The applicant for a pharmacy permit shall show proof by affidavit that the applicant has ordered or possesses and shall continue to maintain an inventory of nonproprietary drugs, devices and equipment appropriate to the practice of that pharmacy. The inventory shall include at least $5,000 worth of nonproprietary drugs and devices, at cost, from a licensed wholesaler or manufacturer. The inventory may not go below this figure at any time.
(b) Drugs which must be removed from active stock shall be removed in accordance with the following provisions:
(1) The pharmacist manager is responsible for removing from the active stock of the pharmacy and disposing of the following:
(i) A drug whose expiration date has passed.
(ii) A drug which does not meet legal standards of strength and purity.
(iii) A drug which varies from the strength and purity indicated on the label of the commercial container.
(iv) A drug which has been improperly stored.
(v) A drug which has deteriorated.
(vi) A drug which is unfit, misbranded or adulterated under Federal or State statutes.
(2) Drugs which have been removed from active stock in accordance with this subsection may not be sold or given away. The drugs shall be returned to the wholesaler or manufacturer for disposal or disposed of by the pharmacy according to Federal or State statutes or regulations.
(3) A pharmacy desiring to or required to dispose of a controlled substance shall contact the nearest DEA office for authority and instructions to dispose of the substance.
(4) The pharmacist manager shall be responsible for keeping proper records of controlled substances which have been disposed of. These records shall include the name of the substance, the number of units or the volume of the substance or the number of commercial containers and the date and manner of disposal.
(c) A pharmacy shall maintain at least the following equipment and supplies:
(1) A Class A prescription balance or other scale with a no-load sensitivity of 6 milligrams or less.
(2) Both an apothecary set of weights from 1/2 grain to 1 ounce and a set of metric weights from 10 milligrams to 50 grams.
(3) A mechanical refrigerator having the appropriate temperature control for the storage of the drugs, vaccines, biologicals or medicaments which require specific temperatures for their stability. The refrigerator shall be kept within the prescription area.
(4) At least four graduates assorted to measure 1 ml to 500 ml.
(5) At least two mortars and pestals, glass or wedgewood.
(6) At least three spatulas of assorted sizes, metallic-rust resistant and rubber or nonmetallic composition.
(7) At least two funnels, one 120 ml and the other 480 ml.
(8) One glass or tile slab or specially treated paper for use in compounding ointments.
(9) A book to record sales and transfers of Schedule V controlled substances and poisons. This paragraph does not apply to an institutional pharmacy servicing only inpatients.
(10) An adequate supply of filter paper and powder papers and an adequate supply of empty capsules, prescription containers, prescription and poison and other applicable identification labels used in dispensing of prescription drugs and medication.
(11) Prescription files for keeping prescriptions of nonproprietary drugs in accordance with the act and, for controlled substance prescriptions, the regulations of the DEA in 21 CFR 1304.04(h) (relating to maintenance of records and inventories). The original prescription shall be retained for 2 years. A pharmacy may make use of a computerized recordkeeping system for keeping track of telephone prescriptions, refills, counseling, and the like, if the system has safeguards to prevent accidental erasure and the information can be transferred to hard copy within 72 hours.
(12) Current copies of the act and this chapter.
(13) Federal and Commonwealth statutes and regulations pertaining to the practice of pharmacy.
(14) An adequate reference library which meets the following standards:
(i) Enables a pharmacy to prepare and dispense prescriptions properly, consistent with its scope of practice.
(ii) Includes reference sources appropriate to the type of pharmacy practice at that particular location. A pharmacy shall include in the pharmacy's library current material regarding the technical, clinical and professional aspects of practice with emphasis in the area in which the pharmacy specializes.
(iii) Enables the pharmacist to compound medications in a safe and effective manner consistent with accepted standards of pharmacy practice.
(iv) Lists the possible drug interactions and possible adverse effects of medications dispensed by the pharmacy.
(v) Lists the therapeutic equivalents for medications.
(vi) Lists the therapeutic usage and dosages of medications dispensed by the pharmacy.
(vii) Provides guidelines for the counseling of patients.
(viii) A pharmacy that specializes in nuclear or parenteral prescriptions may limit the library it maintains under subparagraph (ii) relating to the pharmacy's own specialization.
(ix) Maintains the latest editions including current supplements of each of its reference sources.
§ 27.20. Facsimile machines.
(a) Schedule II controlled substances.
(1) A pharmacist may fill a prescription for a Schedule II controlled substance which was received on a facsimile machine if the original prescription signed by the medical practitioner is presented to the pharmacist for review prior to the actual dispensing of the controlled substance. The original prescription shall be maintained as the original pharmacy record.
(2) There are three exceptions to the requirement that the pharmacist review the original of the prescription received on a facsimile machine before dispensing a Schedule II controlled substance. A pharmacist may fill and dispense a prescription for a Schedule II controlled substance which was received on a facsimile machine and may use the facsimile as the original pharmacy record of the following:
(i) A prescription for a Schedule II controlled narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion in the patient's home.
(ii) A prescription for a Schedule II controlled substance for a resident of a long-term care facility.
(iii) A prescription for a Schedule II controlled narcotic substance for a patient enrolled in a hospice care program.
(b) Schedule III, IV and V controlled substances and other nonproprietary drugs. A pharmacist may fill and dispense a prescription signed by a medical practitioner for a Schedule III, IV or V controlled substance or other nonproprietary drug which was received on a facsimile machine. The pharmacist may use the facsimile as the original pharmacy record.
(c) General.
(1) A pharmacist shall exercise professional judgment regarding the accuracy and authenticity of the facsimile copy of a prescription.
(2) Unless the original prescription will be maintained as the original pharmacy record, the quality of paper on which a facsimile copy of a prescription is printed shall be of a type that the facsimile copy can be maintained as a record for at least 2 years, as required under section 4(a)(3) of the act (63 P. S. § 390-4(a)(3)).
(3) A pharmacist or pharmacy may not contribute in any way to the installation of a facsimile machine in the office of a medical practitioner or in an institution.
(4) For purposes of this section, a prescription does not include an order for medication which is dispensed for immediate administration to a patient in an institution.
[Pa.B. Doc. No. 02-340. Filed for public inspection March 1, 2002, 9:00 a.m.]
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