Florida Senate - 2020                        COMMITTEE AMENDMENT
       Bill No. CS for SB 708
       
       
       
       
       
       
                                Ì936048:Î936048                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                   Comm: WD            .                                
                  01/31/2020           .                                
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       The Committee on Innovation, Industry, and Technology (Hutson)
       recommended the following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Between lines 87 and 88
    4  insert:
    5         Section 2. Section 465.003, Florida Statutes, is reordered
    6  and amended to read:
    7         465.003 Definitions.—As used in this chapter, the term:
    8         (1) “Administration” means the obtaining and giving of a
    9  single dose of medicinal drugs by a legally authorized person to
   10  a patient for her or his consumption.
   11         (3)(2) “Board” means the Board of Pharmacy.
   12         (9)(3) “Consultant pharmacist” means a pharmacist licensed
   13  by the department and certified as a consultant pharmacist
   14  pursuant to s. 465.0125.
   15         (10)(4) “Data communication device” means an electronic
   16  device that receives electronic information from one source and
   17  transmits or routes it to another, including, but not limited
   18  to, any such bridge, router, switch, or gateway.
   19         (11)(5) “Department” means the Department of Health.
   20         (12)(6) “Dispense” means the transfer of possession of one
   21  or more doses of a medicinal drug by a pharmacist to the
   22  ultimate consumer or her or his agent. As an element of
   23  dispensing, the pharmacist shall, prior to the actual physical
   24  transfer, interpret and assess the prescription order for
   25  potential adverse reactions, interactions, and dosage regimen
   26  she or he deems appropriate in the exercise of her or his
   27  professional judgment, and the pharmacist shall certify that the
   28  medicinal drug called for by the prescription is ready for
   29  transfer. The pharmacist shall also provide counseling on proper
   30  drug usage, either orally or in writing, if in the exercise of
   31  her or his professional judgment counseling is necessary. The
   32  actual sales transaction and delivery of such drug shall not be
   33  considered dispensing. The administration shall not be
   34  considered dispensing.
   35         (13)“Establishment” means a place of business that is
   36  located at one general physical location and that may extend to
   37  one or more contiguous suites, units, floors, or buildings
   38  operated and controlled exclusively by entities under common
   39  operation and control. The term includes multiple buildings with
   40  an intervening thoroughfare if the buildings are under common
   41  exclusive ownership, operation, and control. For purposes of
   42  permitting, each suite, unit, floor, or building must be
   43  identified in the most recent permit application.
   44         (14)(7) “Institutional formulary system” means a method
   45  whereby the medical staff evaluates, appraises, and selects
   46  those medicinal drugs or proprietary preparations that, which in
   47  the medical staff’s clinical judgment, are most useful in
   48  patient care, and that which are available for dispensing by a
   49  practicing pharmacist in a Class II or Class III institutional
   50  pharmacy.
   51         (15)(8) “Medicinal drugs” or “drugs” means those substances
   52  or preparations commonly known as “prescription” or “legend”
   53  drugs which are required by federal or state law to be dispensed
   54  only on a prescription, but does shall not include patents or
   55  proprietary preparations as hereafter defined in subsection
   56  (18).
   57         (18)(9) “Patent or proprietary preparation” means a
   58  medicine in its unbroken, original package which is sold to the
   59  public by, or under the authority of, the manufacturer or
   60  primary distributor thereof and which is not misbranded under
   61  the provisions of the Florida Drug and Cosmetic Act.
   62         (19)(10) “Pharmacist” means any person licensed pursuant to
   63  this chapter to practice the profession of pharmacy.
   64         (20)(11)(a) “Pharmacy” includes a community pharmacy, an
   65  institutional pharmacy, a nuclear pharmacy, a special pharmacy,
   66  and an Internet pharmacy.
   67         1. The term “community pharmacy” includes every location
   68  where medicinal drugs are compounded, dispensed, stored, or sold
   69  or where prescriptions are filled or dispensed on an outpatient
   70  basis.
   71         2. The term “institutional pharmacy” includes every
   72  location in a hospital, clinic, nursing home, dispensary,
   73  sanitarium, extended care facility, or other facility,
   74  hereinafter referred to as “health care institutions,” where
   75  medicinal drugs are compounded, dispensed, stored, or sold.
   76         3. The term “nuclear pharmacy” includes every location
   77  where radioactive drugs and chemicals within the classification
   78  of medicinal drugs are compounded, dispensed, stored, or sold.
   79  The term “nuclear pharmacy” does not include hospitals licensed
   80  under chapter 395 or the nuclear medicine facilities of such
   81  hospitals.
   82         4. The term “special pharmacy” includes every location
   83  where medicinal drugs are compounded, dispensed, stored, or sold
   84  if such locations are not otherwise defined in this subsection.
   85         5. The term “Internet pharmacy” includes locations not
   86  otherwise licensed or issued a permit under this chapter, within
   87  or outside this state, which use the Internet to communicate
   88  with or obtain information from consumers in this state and use
   89  such communication or information to fill or refill
   90  prescriptions or to dispense, distribute, or otherwise engage in
   91  the practice of pharmacy in this state. Any act described in
   92  this definition constitutes the practice of pharmacy as defined
   93  in subsection (22)(13).
   94         (b) The pharmacy department of any permittee is shall be
   95  considered closed whenever a Florida licensed pharmacist is not
   96  present and on duty. The term “not present and on duty” may
   97  shall not be construed to prevent a pharmacist from exiting the
   98  prescription department for the purposes of consulting or
   99  responding to inquiries or providing assistance to patients or
  100  customers, attending to personal hygiene needs, or performing
  101  any other function for which the pharmacist is responsible,
  102  provided that such activities are conducted in a manner
  103  consistent with the pharmacist’s responsibility to provide
  104  pharmacy services.
  105         (21)(12) “Pharmacy intern” means a person who is currently
  106  registered in, and attending, a duly accredited college or
  107  school of pharmacy, or who is a graduate of such a school or
  108  college of pharmacy, and who is duly and properly registered
  109  with the department as provided by department rule for under its
  110  rules.
  111         (22)(13) “Practice of the profession of pharmacy” includes
  112  compounding, dispensing, and consulting concerning contents,
  113  therapeutic values, and uses of any medicinal drug; consulting
  114  concerning therapeutic values and interactions of patent or
  115  proprietary preparations, whether pursuant to prescriptions or
  116  in the absence and entirely independent of such prescriptions or
  117  orders; and conducting other pharmaceutical services. For
  118  purposes of this subsection, “other pharmaceutical services”
  119  means the monitoring of the patient’s drug therapy and assisting
  120  the patient in the management of his or her drug therapy, and
  121  includes review of the patient’s drug therapy and communication
  122  with the patient’s prescribing health care provider as licensed
  123  under chapter 458, chapter 459, chapter 461, or chapter 466, or
  124  similar statutory provision in another jurisdiction, or such
  125  provider’s agent or such other persons as specifically
  126  authorized by the patient, regarding the drug therapy. However,
  127  nothing in this subsection may not be interpreted to permit an
  128  alteration of a prescriber’s directions, the diagnosis or
  129  treatment of any disease, the initiation of any drug therapy,
  130  the practice of medicine, or the practice of osteopathic
  131  medicine, unless otherwise permitted by law. The term “practice
  132  of the profession of pharmacy” also includes any other act,
  133  service, operation, research, or transaction incidental to, or
  134  forming a part of, any of the foregoing acts, requiring,
  135  involving, or employing the science or art of any branch of the
  136  pharmaceutical profession, study, or training, and shall
  137  expressly authorizes permit a pharmacist to transmit information
  138  from persons authorized to prescribe medicinal drugs to their
  139  patients. The practice of the profession of pharmacy also
  140  includes the administration of vaccines to adults pursuant to s.
  141  465.189 and the preparation of prepackaged drug products in
  142  facilities holding Class III institutional pharmacy permits.
  143         (23)(14) “Prescription” includes any order for drugs or
  144  medicinal supplies written or transmitted by any means of
  145  communication by a duly licensed practitioner authorized by the
  146  laws of this the state to prescribe such drugs or medicinal
  147  supplies and which drugs or medicinal supplies are intended to
  148  be dispensed by a pharmacist. The term also includes an orally
  149  transmitted order by the lawfully designated agent of such a
  150  practitioner. The term also includes an order written or
  151  transmitted by a practitioner licensed to practice in a
  152  jurisdiction other than this state, but only if the pharmacist
  153  called upon to dispense such order determines, in the exercise
  154  of her or his professional judgment, that the order is valid and
  155  necessary for the treatment of a chronic or recurrent illness;
  156  and. The term “prescription” also includes a pharmacist’s order
  157  for a product selected from the formulary created pursuant to s.
  158  465.186. Prescriptions may be retained in written form or the
  159  pharmacist may cause them to be recorded in a data processing
  160  system, provided that such order can be produced in printed form
  161  upon lawful request.
  162         (16)(15) “Nuclear pharmacist” means a pharmacist licensed
  163  by the department and certified as a nuclear pharmacist pursuant
  164  to s. 465.0126.
  165         (5)(16) “Centralized prescription filling” means the
  166  filling of a prescription by one pharmacy upon the request of by
  167  another pharmacy to fill or refill the prescription. The term
  168  includes the performance by one pharmacy for another pharmacy of
  169  other pharmacy duties, such as drug utilization review,
  170  therapeutic drug utilization review, claims adjudication, and
  171  the obtaining of refill authorizations.
  172         (2)(17) “Automated pharmacy system” means a mechanical
  173  system that delivers prescription drugs received from a Florida
  174  licensed Florida licensed pharmacy and maintains related
  175  transaction information.
  176         (8)(18) “Compounding” means combining, mixing, or altering
  177  the ingredients of one or more drugs or products to create
  178  another drug or product.
  179         (17)(19) “Outsourcing facility” means a single physical
  180  location registered as an outsourcing facility under the federal
  181  Drug Quality and Security Act, Pub. L. No. 113-54, at which
  182  sterile compounding of a drug or product is conducted.
  183         (7)(20) “Compounded sterile product” means a drug that is
  184  intended for parenteral administration, an ophthalmic or oral
  185  inhalation drug in aqueous format, or a drug or product that is
  186  required to be sterile under federal or state law or rule, which
  187  is produced through compounding, but is not approved by the
  188  United States Food and Drug Administration.
  189         (4)(21) “Central distribution facility” means a facility
  190  under common control with a hospital holding a Class III
  191  institutional pharmacy permit that may dispense, distribute,
  192  compound, or fill prescriptions for medicinal drugs; prepare
  193  prepackaged drug products; and conduct other pharmaceutical
  194  services.
  195         (6)(22) “Common control” means the power to direct or cause
  196  the direction of the management and policies of a person or an
  197  organization, whether by ownership of stock, voting rights,
  198  contract, or otherwise.
  199         Section 3. Paragraph (a) of subsection (1) of section
  200  409.9201, Florida Statutes, is amended to read:
  201         409.9201 Medicaid fraud.—
  202         (1) As used in this section, the term:
  203         (a) “Prescription drug” means any drug, including, but not
  204  limited to, finished dosage forms or active ingredients that are
  205  subject to, defined in, or described in s. 503(b) of the Federal
  206  Food, Drug, and Cosmetic Act or in s. 465.003(15) s. 465.003(8),
  207  s. 499.003(17), s. 499.007(13), or s. 499.82(10).
  208  
  209  The value of individual items of the legend drugs or goods or
  210  services involved in distinct transactions committed during a
  211  single scheme or course of conduct, whether involving a single
  212  person or several persons, may be aggregated when determining
  213  the punishment for the offense.
  214         Section 4. Paragraph (pp) of subsection (1) of section
  215  458.331, Florida Statutes, is amended to read:
  216         458.331 Grounds for disciplinary action; action by the
  217  board and department.—
  218         (1) The following acts constitute grounds for denial of a
  219  license or disciplinary action, as specified in s. 456.072(2):
  220         (pp) Applicable to a licensee who serves as the designated
  221  physician of a pain-management clinic as defined in s. 458.3265
  222  or s. 459.0137:
  223         1. Registering a pain-management clinic through
  224  misrepresentation or fraud;
  225         2. Procuring, or attempting to procure, the registration of
  226  a pain-management clinic for any other person by making or
  227  causing to be made, any false representation;
  228         3. Failing to comply with any requirement of chapter 499,
  229  the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  230  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  231  the Drug Abuse Prevention and Control Act; or chapter 893, the
  232  Florida Comprehensive Drug Abuse Prevention and Control Act;
  233         4. Being convicted or found guilty of, regardless of
  234  adjudication to, a felony or any other crime involving moral
  235  turpitude, fraud, dishonesty, or deceit in any jurisdiction of
  236  the courts of this state, of any other state, or of the United
  237  States;
  238         5. Being convicted of, or disciplined by a regulatory
  239  agency of the Federal Government or a regulatory agency of
  240  another state for, any offense that would constitute a violation
  241  of this chapter;
  242         6. Being convicted of, or entering a plea of guilty or nolo
  243  contendere to, regardless of adjudication, a crime in any
  244  jurisdiction of the courts of this state, of any other state, or
  245  of the United States which relates to the practice of, or the
  246  ability to practice, a licensed health care profession;
  247         7. Being convicted of, or entering a plea of guilty or nolo
  248  contendere to, regardless of adjudication, a crime in any
  249  jurisdiction of the courts of this state, of any other state, or
  250  of the United States which relates to health care fraud;
  251         8. Dispensing any medicinal drug based upon a communication
  252  that purports to be a prescription as defined in s. 465.003 s.
  253  465.003(14) or s. 893.02 if the dispensing practitioner knows or
  254  has reason to believe that the purported prescription is not
  255  based upon a valid practitioner-patient relationship; or
  256         9. Failing to timely notify the board of the date of his or
  257  her termination from a pain-management clinic as required by s.
  258  458.3265(3).
  259         Section 5. Paragraph (rr) of subsection (1) of section
  260  459.015, Florida Statutes, is amended to read:
  261         459.015 Grounds for disciplinary action; action by the
  262  board and department.—
  263         (1) The following acts constitute grounds for denial of a
  264  license or disciplinary action, as specified in s. 456.072(2):
  265         (rr) Applicable to a licensee who serves as the designated
  266  physician of a pain-management clinic as defined in s. 458.3265
  267  or s. 459.0137:
  268         1. Registering a pain-management clinic through
  269  misrepresentation or fraud;
  270         2. Procuring, or attempting to procure, the registration of
  271  a pain-management clinic for any other person by making or
  272  causing to be made, any false representation;
  273         3. Failing to comply with any requirement of chapter 499,
  274  the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  275  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  276  the Drug Abuse Prevention and Control Act; or chapter 893, the
  277  Florida Comprehensive Drug Abuse Prevention and Control Act;
  278         4. Being convicted or found guilty of, regardless of
  279  adjudication to, a felony or any other crime involving moral
  280  turpitude, fraud, dishonesty, or deceit in any jurisdiction of
  281  the courts of this state, of any other state, or of the United
  282  States;
  283         5. Being convicted of, or disciplined by a regulatory
  284  agency of the Federal Government or a regulatory agency of
  285  another state for, any offense that would constitute a violation
  286  of this chapter;
  287         6. Being convicted of, or entering a plea of guilty or nolo
  288  contendere to, regardless of adjudication, a crime in any
  289  jurisdiction of the courts of this state, of any other state, or
  290  of the United States which relates to the practice of, or the
  291  ability to practice, a licensed health care profession;
  292         7. Being convicted of, or entering a plea of guilty or nolo
  293  contendere to, regardless of adjudication, a crime in any
  294  jurisdiction of the courts of this state, of any other state, or
  295  of the United States which relates to health care fraud;
  296         8. Dispensing any medicinal drug based upon a communication
  297  that purports to be a prescription as defined in s. 465.003 s.
  298  465.003(14) or s. 893.02 if the dispensing practitioner knows or
  299  has reason to believe that the purported prescription is not
  300  based upon a valid practitioner-patient relationship; or
  301         9. Failing to timely notify the board of the date of his or
  302  her termination from a pain-management clinic as required by s.
  303  459.0137(3).
  304         Section 6. Subsection (1) of section 465.014, Florida
  305  Statutes, is amended to read:
  306         465.014 Pharmacy technician.—
  307         (1) A person other than a licensed pharmacist or pharmacy
  308  intern may not engage in the practice of the profession of
  309  pharmacy, except that a licensed pharmacist may delegate to
  310  pharmacy technicians who are registered pursuant to this section
  311  those duties, tasks, and functions that do not fall within the
  312  purview of s. 456.003(22) s. 465.003(13). All such delegated
  313  acts must be performed under the direct supervision of a
  314  licensed pharmacist who is responsible for all such acts
  315  performed by persons under his or her supervision. A registered
  316  pharmacy technician, under the supervision of a pharmacist, may
  317  initiate or receive communications with a practitioner or his or
  318  her agent, on behalf of a patient, regarding refill
  319  authorization requests. A licensed pharmacist may not supervise
  320  more than one registered pharmacy technician unless otherwise
  321  permitted by the guidelines adopted by the board. The board
  322  shall establish guidelines to be followed by licensees or
  323  permittees in determining the circumstances under which a
  324  licensed pharmacist may supervise more than one pharmacy
  325  technician.
  326         Section 7. Paragraph (c) of subsection (2) of section
  327  465.015, Florida Statutes, is amended to read:
  328         465.015 Violations and penalties.—
  329         (2) It is unlawful for any person:
  330         (c) To sell or dispense drugs as defined in s. 465.003(15)
  331  s. 465.003(8) without first being furnished with a prescription.
  332         Section 8. Subsection (9) of section 465.0156, Florida
  333  Statutes, is amended to read:
  334         465.0156 Registration of nonresident pharmacies.—
  335         (9) Notwithstanding s. 465.003(19) s. 465.003(10), for
  336  purposes of this section, the registered pharmacy and the
  337  pharmacist designated by the registered pharmacy as the
  338  prescription department manager or the equivalent must be
  339  licensed in the state of location in order to dispense into this
  340  state.
  341         Section 9. Paragraph (s) of subsection (1) of section
  342  465.016, Florida Statutes, is amended to read:
  343         465.016 Disciplinary actions.—
  344         (1) The following acts constitute grounds for denial of a
  345  license or disciplinary action, as specified in s. 456.072(2):
  346         (s) Dispensing any medicinal drug based upon a
  347  communication that purports to be a prescription as defined in
  348  s. 465.003 by s. 465.003(14) or s. 893.02 when the pharmacist
  349  knows or has reason to believe that the purported prescription
  350  is not based upon a valid practitioner-patient relationship.
  351         Section 10. Subsection (4) of section 465.0197, Florida
  352  Statutes, is amended to read:
  353         465.0197 Internet pharmacy permits.—
  354         (4) Notwithstanding s. 465.003(19) s. 465.003(10), for
  355  purposes of this section, the Internet pharmacy and the
  356  pharmacist designated by the Internet pharmacy as the
  357  prescription department manager or the equivalent must be
  358  licensed in the state of location in order to dispense into this
  359  state.
  360         Section 11. Paragraph (j) of subsection (5) of section
  361  465.022, Florida Statutes, is amended to read:
  362         465.022 Pharmacies; general requirements; fees.—
  363         (5) The department or board shall deny an application for a
  364  pharmacy permit if the applicant or an affiliated person,
  365  partner, officer, director, or prescription department manager
  366  or consultant pharmacist of record of the applicant:
  367         (j) Has dispensed any medicinal drug based upon a
  368  communication that purports to be a prescription as defined in
  369  s. 465.003 by s. 465.003(14) or s. 893.02 when the pharmacist
  370  knows or has reason to believe that the purported prescription
  371  is not based upon a valid practitioner-patient relationship that
  372  includes a documented patient evaluation, including history and
  373  a physical examination adequate to establish the diagnosis for
  374  which any drug is prescribed and any other requirement
  375  established by board rule under chapter 458, chapter 459,
  376  chapter 461, chapter 463, chapter 464, or chapter 466.
  377  
  378  For felonies in which the defendant entered a plea of guilty or
  379  nolo contendere in an agreement with the court to enter a
  380  pretrial intervention or drug diversion program, the department
  381  shall deny the application if upon final resolution of the case
  382  the licensee has failed to successfully complete the program.
  383         Section 12. Paragraph (h) of subsection (1) of section
  384  465.023, Florida Statutes, is amended to read:
  385         465.023 Pharmacy permittee; disciplinary action.—
  386         (1) The department or the board may revoke or suspend the
  387  permit of any pharmacy permittee, and may fine, place on
  388  probation, or otherwise discipline any pharmacy permittee if the
  389  permittee, or any affiliated person, partner, officer, director,
  390  or agent of the permittee, including a person fingerprinted
  391  under s. 465.022(3), has:
  392         (h) Dispensed any medicinal drug based upon a communication
  393  that purports to be a prescription as defined in s. 465.003 by
  394  s. 465.003(14) or s. 893.02 when the pharmacist knows or has
  395  reason to believe that the purported prescription is not based
  396  upon a valid practitioner-patient relationship that includes a
  397  documented patient evaluation, including history and a physical
  398  examination adequate to establish the diagnosis for which any
  399  drug is prescribed and any other requirement established by
  400  board rule under chapter 458, chapter 459, chapter 461, chapter
  401  463, chapter 464, or chapter 466.
  402         Section 13. Section 465.1901, Florida Statutes, is amended
  403  to read:
  404         465.1901 Practice of orthotics and pedorthics.—The
  405  provisions of chapter 468 relating to orthotics or pedorthics do
  406  not apply to any licensed pharmacist or to any person acting
  407  under the supervision of a licensed pharmacist. The practice of
  408  orthotics or pedorthics by a pharmacist or any of the
  409  pharmacist’s employees acting under the supervision of a
  410  pharmacist shall be construed to be within the meaning of the
  411  term “practice of the profession of pharmacy” as defined in s.
  412  465.003 set forth in s. 465.003(13), and shall be subject to
  413  regulation in the same manner as any other pharmacy practice.
  414  The Board of Pharmacy shall develop rules regarding the practice
  415  of orthotics and pedorthics by a pharmacist. Any pharmacist or
  416  person under the supervision of a pharmacist engaged in the
  417  practice of orthotics or pedorthics is not precluded from
  418  continuing that practice pending adoption of these rules.
  419         Section 14. Subsection (40) of section 499.003, Florida
  420  Statutes, is amended to read:
  421         499.003 Definitions of terms used in this part.—As used in
  422  this part, the term:
  423         (40) “Prescription drug” means a prescription, medicinal,
  424  or legend drug, including, but not limited to, finished dosage
  425  forms or active pharmaceutical ingredients subject to, defined
  426  by, or described by s. 503(b) of the federal act or s.
  427  465.003(15) s. 465.003(8), s. 499.007(13), subsection (31), or
  428  subsection (47), except that an active pharmaceutical ingredient
  429  is a prescription drug only if substantially all finished dosage
  430  forms in which it may be lawfully dispensed or administered in
  431  this state are also prescription drugs.
  432         Section 15. Paragraph (c) of subsection (24) of section
  433  893.02, Florida Statutes, is amended to read:
  434         893.02 Definitions.—The following words and phrases as used
  435  in this chapter shall have the following meanings, unless the
  436  context otherwise requires:
  437         (24) “Prescription” includes any order for drugs or
  438  medicinal supplies which is written or transmitted by any means
  439  of communication by a licensed practitioner authorized by the
  440  laws of this state to prescribe such drugs or medicinal
  441  supplies, is issued in good faith and in the course of
  442  professional practice, is intended to be dispensed by a person
  443  authorized by the laws of this state to do so, and meets the
  444  requirements of s. 893.04.
  445         (c) A prescription for a controlled substance may not be
  446  issued on the same prescription blank with another prescription
  447  for a controlled substance that is named or described in a
  448  different schedule or with another prescription for a medicinal
  449  drug, as defined in s. 465.003 s. 465.003(8), that is not a
  450  controlled substance.
  451  
  452  ================= T I T L E  A M E N D M E N T ================
  453  And the title is amended as follows:
  454         Between lines 9 and 10
  455  insert:
  456         reordering and amending s. 465.003, F.S.; defining the
  457         term “establishment”; amending ss. 409.9201, 458.331,
  458         459.015, 465.014, 465.015, 465.0156, 465.016,
  459         465.0197, 465.022, 465.023, 465.1901, 499.003, and
  460         893.02, F.S.; conforming cross-references;