FLORIDA - DRUGS

March 18, 2008

Florida state laws and regulations that affect your medical practice

1. What are the standards for the use of controlled substances for treatment of pain?

(a) Evaluation of the Patient: A complete medical history and physical examination must be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.

(b) Treatment Plan: The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.

( c ) Informed Consent and Agreement for Treatment: The physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient, or with the patient’s surrogate or guardian if the patient is incompetent. The patient should receive prescriptions from one physician and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the physician should employ the use of a written agreement between physician and patient outlining patient responsibilities, including, but not limited to:

1. Urine/serum medication levels screening when requested;

2. Number and frequency of all prescription refills; and

3. Reasons for which drug therapy may be discontinued (i.e., violation of agreement).

(d) Periodic Review: At reasonable intervals based on the individual circumstances of the patient, the physician should review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy should depend on the physician’s evaluation of the patient’s progress. If treatment goals are not being achieved, despite medication adjustments, the physician should reevaluate the appropriateness of continued treatment. The physician should monitor patient compliance in medication usage and related treatment plans.

(e) Consultation: The physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those pain patients who are at risk for misusing their medications and those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder requires extra care, monitoring, and documentation, and may require consultation with or referral to an expert in the management of such patients.

(f) Medical Records: The physician is required to keep accurate and complete records to include, but not be limited to:

1. The medical history and physical examination, including history of drug abuse or dependence, as appropriate;

2. Diagnostic, therapeutic, and laboratory results;

3. Evaluations and consultations;

4. Treatment objectives;

5. Discussion of risks and benefits;

6. Treatments;

7. Medications (including date, type, dosage and quantity prescribed);

8. Instructions and agreements; and

9. Periodic reviews.

(g) Compliance with Controlled Substances Laws and Regulations: To prescribe, dispense or administer controlled substances, the physician must be licensed in the state and comply with applicable federal and state regulations.

64 FL ADC 64B8-9.013

2. What are the standards for telemedicine prescribing?

(1) Prescribing medications based solely on an electronic medical questionnaire constitutes the failure to practice medicine with that level of care, skill and treatment which is recognized by reasonably prudent physicians as being acceptable under similar conditions and circumstances, as well as prescribing legend drugs other than in the course of a physician’s professional practice.

(2) Physicians and physician assistants shall not provide treatment recommendations, including issuing a prescription, via electronic or other means, unless the following elements have been met:

(a) A documented patient evaluation, including history and physical examination to establish the diagnosis for which any legend drug is prescribed.

(b) Discussion between the physician or the physician assistant and the patient regarding treatment options and the risks and benefits of treatment.

( c ) Maintenance of contemporaneous medical records.

(3) The provisions of this rule are not applicable to an emergency situation – those situations in which the prescribing physician or physician assistant determines that the immediate administration of the medication is necessary for the proper treatment of the patient, and that it is not reasonably possible for the prescribing physician or physician assistant to comply with the provision of this rule prior to providing such prescription.

(4) The provisions of this rule shall not be construed to prohibit patient care in consultation with another physician who has an ongoing relationship with the patient, and who has agreed to supervise the patient’s treatment, including the use of any prescribed medications, nor on-call or cross-coverage situations in which the physician has access to patient records.

(5) The term “telemedicine” includes, but is not limited to, prescribing legend drugs to patients through the internet, telephone and facsimile.

64 FL ADC 64B8-9.014

3. How are “controlled substances” regulated in Florida?

(1) Schedule I.: A substance in Schedule I has a high potential for abuse and has no currently accepted medical use in treatment in the United States and in its use under medical supervision does not meet accepted safety standards. The following substances are controlled in Schedule I:

(a) Unless specifically excepted or unless listed in another schedule, any of the following substances, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, are controlled in Schedule I:

1. Acetyl-alpha-methylfentanyl.
2. Acetylmethadol.
3. Allylprodine.
4. Alphacetylmethadol (except levo-alphacetylmethadol, also known as levo-alpha-acetylmethadol, levomethadyl acetate, or LAAM).
5. Alphamethadol.
6. Alpha-methylfentanyl (N-[1-(alpha-methyl-betaphenyl) ethyl-4-piperidyl] propionanilide; 1-(1-methyl-2-phenylethyl)-4-(N-propanilido) piperidine).
7. Alpha-methylthiofentanyl.
8. Alphameprodine.
9. Benzethidine.
10. Benzylfentanyl.
11. Betacetylmethadol.
12. Beta-hydroxyfentanyl.
13 Beta-hydroxy-3-methylfentanyl.
14. Betameprodine.
15. Betamethadol.
16. Betaprodine.
17. Clonitazene.
18. Dextromoramide.
19. Diampromide.
20. Diethylthiambutene.
21. Difenoxin.
22. Dimenoxadol.
23. Dimepheptanol.
24. Dimethylthiambutene.
25. Dioxaphetyl butyrate.
26. Dipipanone.
27. Ethylmethylthiambutene.
28. Etonitazene.
29. Etoxeridine.
30. Flunitrazepam.
31. Furethidine.
32. Hydroxypethidine.
33. Ketobemidone.
34. Levomoramide.
35. Levophenacylmorphan.
36. 1-Methyl-4-Phenyl-4-Propionoxypiperidine (MPPP).
37. 3-Methylfentanyl (N- [3-methyl-1-(2-phenylethyl)-4-piperidyl]-N-phenylpropanamide).
38. 3-Methylthiofentanyl.
39. 3, 4-Methylenedioxymethamphetamine (MDMA).
40. Morpheridine.
41. Noracymethadol.
42. Norlevorphanol.
43. Normethadone.
44. Norpipanone.
45. Para-Fluorofentanyl.
46. Phenadoxone.
47. Phenampromide.
48. Phenomorphan.
49. Phenoperidine.
50. 1-(2-Phenylethyl)-4-Phenyl-4-Acetyloxypiperidine (PEPAP).
51. Piritramide.
52. Proheptazine.
53. Properidine.
54. Propiram.
55. Racemoramide.
56. Thenylfentanyl.
57. Thiofentanyl.
58. Tilidine.
59. Trimeperidine.

(b) Unless specifically excepted or unless listed in another schedule, any of the following substances, their salts, isomers, and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, are controlled in Schedule I:

1. Acetorphine.
2. Acetyldihydrocodeine.
3. Benzylmorphine.
4. Codeine methylbromide.
5. Codeine-N-Oxide.
6. Cyprenorphine.
7. Desomorphine.
8. Dihydromorphine.
9. Drotebanol.
10. Etorphine (except hydrochloride salt).
11. Heroin.
12. Hydromorphinol.
13. Methyldesorphine.
14. Methyldihydromorphine.
15. Monoacetylmorphine.
16. Morphine methylbromide.
17. Morphine methylsulfonate.
18. Morphine-N-Oxide.
19. Myrophine.
20. Nicocodine.
21. Nicomorphine.
22. Normorphine.
23. Pholcodine.
24. Thebacon.

( c ) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following hallucinogenic substances or which contains any of their salts, isomers, and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, are controlled in Schedule I:

1. Alpha-ethyltryptamine.
2. 2-Amino-4-methyl-5-phenyl-2-oxazoline (4-methylaminorex).
3. 2-Amino-5-phenyl-2-oxazoline (Aminorex).
4. 4-Bromo-2,5-dimethoxyamphetamine.
5. 4-Bromo-2, 5-dimethoxyphenethylamine.
6. Bufotenine.
7. Cannabis.
8. Cathinone.
9. Diethyltryptamine.
10. 2,5-Dimethoxyamphetamine.
11. 2,5-Dimethoxy-4-ethylamphetamine (DOET).
12. Dimethyltryptamine.
13. N-Ethyl-1-phenylcyclohexylamine (PCE) (Ethylamine analog of phencyclidine).
14. N-Ethyl-3-piperidyl benzilate.
15. N-ethylamphetamine.
16. Fenethylline.
17. N-Hydroxy-3,4-methylenedioxyamphetamine.
18. Ibogaine.
19. Lysergic acid diethylamide (LSD).
20. Mescaline.
21. Methcathinone.
22. 5-Methoxy-3,4-methylenedioxyamphetamine.
23. 4-methoxyamphetamine.
24. 4-methoxymethamphetamine.
25. 4-Methyl-2,5-dimethoxyamphetamine.
26. 3,4-Methylenedioxy-N-ethylamphetamine.
27. 3,4-Methylenedioxyamphetamine.
28. N-Methyl-3-piperidyl benzilate.
29. N,N-dimethylamphetamine.
30. Parahexyl.
31. Peyote.
32. N-(1-Phenylcyclohexyl)-pyrrolidine (PCPY) (Pyrrolidine analog of phencyclidine).
33. Psilocybin.
34. Psilocyn.
35. Tetrahydrocannabinols.
36. 1-[1-(2-Thienyl)-cyclohexyl]-piperidine (TCP) (Thiophene analog of phencyclidine).
37. 3,4,5-Trimethoxyamphetamine.

(d) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, including any of its salts, isomers, optical isomers, salts of their isomers, and salts of these optical isomers whenever the existence of such isomers and salts is possible within the specific chemical designation, are controlled in Schedule I:

1. 1,4-Butanediol.
2. Gamma-butyrolactone (GBL).
3. Gamma-hydroxybutyric acid (GHB).
4. Methaqualone.
5. Mecloqualone.

(2) Schedule II.: A substance in Schedule II has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States, and abuse of the substance may lead to severe psychological or physical dependence. The following substances are controlled in Schedule II:

(a) Unless specifically excepted or unless listed in another schedule, any of the following substances, whether produced directly or indirectly by extraction from substances of vegetable origin or independently by means of chemical synthesis are controlled in Schedule II:
1. Opium and any salt, compound, derivative, or preparation of opium, except nalmefene or isoquinoline alkaloids of opium, including, but not limited to the following:

a. Raw opium.
b. Opium extracts.
c. Opium fluid extracts.
d. Powdered opium.
e. Granulated opium.
f. Tincture of opium.
g. Codeine.
h. Ethylmorphine.
i. Etorphine hydrochloride.
j. Hydrocodone.
k. Hydromorphone.
l. Levo-alphacetylmethadol (also known as levo-alpha-acetylmethadol, levomethadyl acetate, or LAAM).
m. Metopon (methyldihydromorphinone).
n. Morphine.
o. Oxycodone.
p. Oxymorphone.
q. Thebaine.

2. Any salt, compound, derivative, or preparation of a substance which is chemically equivalent to or identical with any of the substances referred to in subparagraph 1., except that these substances shall not include the isoquinoline alkaloids of opium, is controlled in Schedule II.

3. Any part of the plant of the species Papaver somniferum, L is controlled in Schedule II.

4. Cocaine or ecgonine, including any of their stereoisomers, and any salt, compound, derivative, or preparation of cocaine or ecgonine is controlled in Schedule II.

(b) Unless specifically excepted or unless listed in another schedule, any of the following substances, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, are controlled in Schedule II:

1. Alfentanil.
2. Alphaprodine.
3. Anileridine.
4. Bezitramide.
5. Bulk propoxyphene (nondosage forms).
6. Carfentanil.
7. Dihydrocodeine.
8. Diphenoxylate.
9. Fentanyl.
10. Isomethadone.
11. Levomethorphan.
12. Levorphanol.
13. Metazocine.
14. Methadone.
15. Methadone-Intermediate,4-cyano-2-dimethylamino-4,4-diphenylbutane.
16. Moramide-Intermediate,2-methyl-3-morpholoino-1,1- diphenylpropane-carboxylic acid.
17. Nabilone.
18. Pethidine (meperidine).
19. Pethidine-Intermediate-A,4-cyano-1- methyl-4-phenylpiperidine.
20. Pethidine-Intermediate-B,ethyl-4- phenylpiperidine-4-carboxylate.
21. Pethidine-Intermediate-C,1-methyl-4- phenylpiperidine-4-carboxylic acid.
22. Phenazocine.
23. Phencyclidine.
24. 1-Phenylcyclohexylamine.
25. Piminodine.
26. 1-Piperidinocyclohexanecarbonitrile.
27. Racemethorphan.
28. Racemorphan.
29. Sufentanil.

( c ) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, including their salts, isomers, optical isomers, salts of their isomers, and salts of their optical isomers are controlled in Schedule II:

1. Amobarbital.
2. Amphetamine.
3. Glutethimide.
4. Methamphetamine.
5. Methylphenidate.
6. Pentobarbital.
7. Phenmetrazine.
8. Phenylacetone.
9. Secobarbital.

(3) Schedule III.: A substance in Schedule III has a potential for abuse less than the substances contained in Schedules I and II and has a currently accepted medical use in treatment in the United States, and abuse of the substance may lead to moderate or low physical dependence or high psychological dependence or, in the case of anabolic steroids, may lead to physical damage. The following substances are controlled in Schedule III:

(a) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant or stimulant effect on the nervous system are controlled in Schedule III:

1. Any substance which contains any quantity of a derivative of barbituric acid, including thiobarbituric acid, or any salt of a derivative of barbituric acid or thiobarbituric acid, including, but not limited to, butabarbital and butalbital.
2. Benzphetamine.
3. Chlorhexadol.
4. Chlorphentermine.
5. Clortermine.
6. Lysergic acid.
7. Lysergic acid amide.
8. Methyprylon.
9. Phendimetrazine.
10. Sulfondiethylmethane.
11. Sulfonethylmethane.
12. Sulfonmethane.
13. Tiletamine and zolazepam or any salt thereof.

(b) Nalorphine.

(c ) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing limited quantities of any of the following controlled substances or any salts thereof are controlled in Schedule III:

1. Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium.
2. Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with recognized therapeutic amounts of one or more active ingredients which are not controlled substances.
3. Not more than 300 milligrams of hydrocodone per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium.
4. Not more than 300 milligrams of hydrocodone per 100 milliliters or not more than 15 milligrams per dosage unit, with recognized therapeutic amounts of one or more active ingredients that are not controlled substances.
5. Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with recognized therapeutic amounts of one or more active ingredients which are not controlled substances.
6. Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
7. Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams, with recognized therapeutic amounts of one or more active ingredients which are not controlled substances.

( c ) For purposes of charging a person with a violation involving any controlled substance, the controlled substance is a Schedule III controlled substance pursuant to this paragraph but the weight of the controlled substance per milliliters or per dosage unit is not relevant to the charging of a violation.

(d) Anabolic steroids.

1. The term "anabolic steroid" means any drug or hormonal substance, chemically and pharmacologically related to testosterone, other than estrogens, progestins, and corticosteroids, that promotes muscle growth and includes:

a. Androsterone.
b. Androsterone acetate.
c. Boldenone.
d. Boldenone acetate.
e. Boldenone benzoate.
f. Boldenone undecylenate.
g. Chlorotestosterone (4-chlortestosterone).
h. Clostebol.
i. Dehydrochlormethyltestosterone.
j. Dihydrotestosterone (4-dihydrotestosterone).
k. Drostanolone.
l. Ethylestrenol.
m. Fluoxymesterone.
n. Formebulone (formebolone).
o. Mesterolone.
p. Methandienone.
q. Methandranone.
r. Methandriol.
s. Methandrostenolone.
t. Methenolone.
u. Methyltestosterone.
v. Mibolerone.
w. Nandrolone.
x. Norethandrolone.
y. Nortestosterone.
z. Nortestosterone decanoate.
aa. Nortestosterone phenylpropionate.
bb. Nortestosterone propionate.
cc. Oxandrolone.
dd. Oxymesterone.
ee. Oxymetholone.
ff. Stanolone.
gg. Stanozolol.
hh. Testolactone.
ii Testosterone.
jj. Testosterone acetate.
kk. Testosterone benzoate.
ll. Testosterone cypionate.
mm. Testosterone decanoate.
nn. Testosterone enanthate.
oo. Testosterone isocaproate
pp. Testosterone oleate.
qq. Testosterone phenylpropionate.
rr. Testosterone propionate.
ss. Testosterone undecanoate.
tt. Trenbolone.
uu. Trenbolone acetate.
vv. Any salt, ester, or isomer of a drug or substance described or listed in this subparagraph if that salt, ester, or isomer promotes muscle growth.

2. The term does not include an anabolic steroid that is expressly intended for administration through implants to cattle or other nonhuman species and that has been approved by the United States Secretary of Health and Human Services for such administration. However, any person who prescribes, dispenses, or distributes such a steroid for human use is considered to have prescribed, dispensed, or distributed an anabolic steroid within the meaning of this paragraph.

(e) Ketamine, including any isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation.

(f) Dronabinol (synthetic THC) in sesame oil and encapsulated in a soft gelatin capsule in a drug product approved by the United States Food and Drug Administration.

(g) Any drug product containing gamma-hydroxybutyric acid, including its salts, isomers, and salts of isomers, for which an application is approved under s. 505 of the Federal Food, Drug, and Cosmetic Act.

(4) Schedule IV: A substance in Schedule IV has a low potential for abuse relative to the substances in Schedule III and has a currently accepted medical use in treatment in the United States, and abuse of the substance may lead to limited physical or psychological dependence relative to the substances in Schedule III. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, are controlled in Schedule IV:

(a) Alprazolam.
(b) Barbital.
(c ) Bromazepam.
(d) Camazepam.
(e) Cathine.
(f) Chloral betaine.
(g) Chloral hydrate.
(h) Chlordiazepoxide.
(i) Clobazam.
(j) Clonazepam.
(k) Clorazepate.
(l) Clotiazepam.
(m) Cloxazolam.
(n) Delorazepam.
(o) Propoxyphene (dosage forms).
(p) Diazepam.
(q) Diethylpropion.
( r ) Estazolam.
(s) Ethchlorvynol.
(t) Ethinamate.
(u) Ethyl loflazepate.
(v) Fencamfamin.
(w) Fenfluramine
(x) Fenproporex.
(y) Fludiazepam.
(z) Flurazepam.
(aa) Halazepam.
(bb) Haloxazolam.
(cc) Ketazolam.
(dd) Loprazolam.
(ee) Lorazepam.
(ff) Lormetazepam.
(gg) Mazindol.
(hh) Mebutamate.
(ii) Medazepam.
(jj) Mefenorex.
(kk) Meprobamate.
(ll) Methohexital.
(mm) Methylphenobarbital.
(nn) Midazolam.
(oo) Nimetazepam.
(pp) Nitrazepam.
(qq) Nordiazepam.
(rr) Oxazepam.
(ss) Oxazolam.
(tt) Paraldehyde.
(uu) Pemoline.
(vv) Pentazocine.
(ww) Phenobarbital.
(xx) Phentermine.
(yy) Pinazepam.
(zz) Pipradrol.
(aaa) Prazepam.
(bbb) Propylhexedrine, excluding any patent or proprietary preparation containing propylhexedrine, unless otherwise provided by federal law.
(ccc) Quazepam.
(ddd) Tetrazepam.
(eee) SPA[(-)-1 dimethylamino-1, 2 diphenylethane].
(fff) Temazepam.
(ggg) Triazolam.
(hhh) Not more than 1 milligram of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.
(iii) Butorphanol tartrate.
(jjj) Carisoprodol.

(5) Schedule V: A substance, compound, mixture, or preparation of a substance in Schedule V has a low potential for abuse relative to the substances in Schedule IV and has a currently accepted medical use in treatment in the United States, and abuse of such compound, mixture, or preparation may lead to limited physical or psychological dependence relative to the substances in Schedule IV.

(a) Substances controlled in Schedule V include any compound, mixture, or preparation containing any of the following limited quantities of controlled substances, which shall include one or more active medicinal ingredients which are not controlled substances in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by the controlled substance alone:

1. Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams.
2. Not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams.
3. Not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100 grams.
4. Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit.
5. Not more than 100 milligrams of opium per 100 milliliters or per 100 grams.

(b) Narcotic drugs: Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs and their salts: Buprenorphine.

( c ) Stimulants: Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers, and salts of isomers: Pyrovalerone.

(6) Precursor chemicals: The term "listed precursor chemical" means a chemical that may be used in manufacturing a controlled substance in violation of this chapter and is critical to the creation of the controlled substance, and such term includes any salt, optical isomer, or salt of an optical isomer, whenever the existence of such salt, optical isomer, or salt of optical isomer is possible within the specific chemical designation. The following are "listed precursor chemicals":

1. Anthranilic acid.
2. Benzaldehyde.
3. Benzyl cyanide.
4. Chloroephedrine.
5. Chloropseudoephedrine.
6. Ephedrine.
7. Ergonovine.
8. Ergotamine.
9. Hydriodic acid.
10. Ethylamine.
11. Isosafrole.
12. Methylamine.
13. 3, 4-Methylenedioxyphenyl-2-propanone.
14. N-acetylanthranilic acid.
15. N-ethylephedrine.
16. N-ethylpseudoephedrine.
17. N-methylephedrine.
18. N-methylpseudoephedrine.
19. Nitroethane.
20. Norpseudoephedrine.
21. Phenylacetic acid.
22. Phenylpropanolamine.
23. Piperidine.
24. Piperonal.
25. Propionic anhydride.
26. Pseudoephedrine.
27. Safrole.

(7) Essential chemicals: The term "listed essential chemical" means a chemical that may be used as a solvent, reagent, or catalyst in manufacturing a controlled substance in violation of this chapter. The following are "listed essential chemicals":

1. Acetic anhydride.
2. Acetone.
3. Anhydrous ammonia.
4. Benzyl chloride.
5. 2-Butanone.
6. Ethyl ether.
7. Hydrochloric gas.
8. Hydriodic acid.
9. Iodine.
10. Potassium permanganate.
11. Toluene.

Florida Statutes, Chapter 893, “Florida Comprehensive Drug Abuse Prevention and Control Act”

4. What procedures must be followed by Florida pharmacists?

(1) A pharmacist, in good faith and in the course of professional practice only, may dispense controlled substances upon a written or oral prescription of a practitioner, under the following conditions:

(a) Oral prescriptions must be promptly reduced to writing by the pharmacist.

(b) The written prescription must be dated and signed by the prescribing practitioner on the day when issued.

( c ) There shall appear on the face of the prescription or written record thereof for the controlled substance the following information:

1. The full name and address of the person for whom, or the owner of the animal for which, the controlled substance is dispensed.

2. The full name and address of the prescribing practitioner and the practitioner's federal controlled substance registry number shall be printed thereon.

3. If the prescription is for an animal, the species of animal for which the controlled substance is prescribed.

4. The name of the controlled substance prescribed and the strength, quantity, and directions for use thereof.

5. The number of the prescription, as recorded in the prescription files of the pharmacy in which it is filled.

6. The initials of the pharmacist filling the prescription and the date filled.

(d) The prescription shall be retained on file by the proprietor of the pharmacy in which it is filled for a period of 2 years.

(e) Affixed to the original container in which a controlled substance is delivered upon a prescription or authorized refill thereof, as hereinafter provided, there shall be a label bearing the following information:

1. The name and address of the pharmacy from which such controlled substance was dispensed.

2. The date on which the prescription for such controlled substance was filled.

3. The number of such prescription, as recorded in the prescription files of the pharmacy in which it is filled.

4. The name of the prescribing practitioner.

5. The name of the patient for whom, or of the owner and species of the animal for which, the controlled substance is prescribed.

6. The directions for the use of the controlled substance prescribed in the prescription.

7. A clear, concise warning that it is a crime to transfer the controlled substance to any person other than the patient for whom prescribed.

(f) A prescription for a controlled substance listed in Schedule II may be dispensed only upon a written prescription of a practitioner, except that in an emergency situation, as defined by regulation of the Department of Health, such controlled substance may be dispensed upon oral prescription. No prescription for a controlled substance listed in Schedule II may be refilled.

(g) No prescription for a controlled substance listed in Schedules III, IV, or V may be filled or refilled more than five times within a period of 6 months after the date on which the prescription was written unless the prescription is renewed by a practitioner.

(2) Notwithstanding the provisions of subsection (1), a pharmacist may dispense a one-time emergency refill of up to a 72-hour supply of the prescribed medication for any medicinal drug other than a medicinal drug listed in Schedule II, in compliance with the provisions of s. 465.0275

(3) The legal owner of any stock of controlled substances in a pharmacy, upon discontinuance of dealing in controlled substances, may sell said stock to a manufacturer, wholesaler, or pharmacy. Such controlled substances may be sold only upon an order form, when such an order form is required for sale by the drug abuse laws of the United States or this state, or regulations pursuant thereto.

Florida Statutes, Chapter 893, “Florida Comprehensive Drug Abuse Prevention and Control Act”

5. What procedures must be followed by practitioners with regard to controlled substances?

(1) A practitioner, in good faith and in the course of his or her professional practice only, may prescribe, administer, dispense, mix, or otherwise prepare a controlled substance, or the practitioner may cause the same to be administered by a licensed nurse or an intern practitioner under his or her direction and supervision only.

(2) When any controlled substance is dispensed by a practitioner, there shall be affixed to the original container in which the controlled substance is delivered a label on which appears:

(a) The date of delivery.

(b) The directions for use of such controlled substance.

( c ) The name and address of such practitioner.

(d) The name of the patient.

(e) A clear, concise warning that it is a crime to transfer the controlled substance to any person other than the patient for whom prescribed.

(3) Any person who obtains from a practitioner or the practitioner's agent, or pursuant to prescription, any controlled substance for administration to a patient during the absence of such practitioner shall return to such practitioner any unused portion of such controlled substance when it is no longer required by the patient.

Florida Statutes, Chapter 893, “Florida Comprehensive Drug Abuse Prevention and Control Act”

6. Which drugs may be distributed without a prescription?

The following may be distributed at retail without a prescription, but only by a registered pharmacist:

(a) Any compound, mixture, or preparation described in Schedule V.

(b) Any compound, mixture, or preparation containing any depressant or stimulant substance except any amphetamine drug or sympathomimetic amine drug or compound designated as a Schedule II controlled substance or in Schedule IV, if:

1. The compound, mixture, or preparation contains one or more active medicinal ingredients not having depressant or stimulant effect on the central nervous system, and

2. Such ingredients are included therein in such combinations, quantity, proportion, or concentration as to vitiate the potential for abuse of the controlled substances which do have a depressant or stimulant effect on the central nervous system.

(2) No compound, mixture, or preparation may be dispensed under subsection (1) unless such substance may, under the Federal Food, Drug, and Cosmetic Act, be lawfully sold at retail without a prescription.

(3) The exemptions authorized by this section shall be subject to the following conditions:

(a) The compounds, mixtures, and preparations referred to in subsection (1) may be dispensed to persons under age 18 only on prescription. A bound volume must be maintained as a record of sale at retail of excepted compounds, mixtures, and preparations, and the pharmacist must require suitable identification from every unknown purchaser.

(b) Such compounds, mixtures, and preparations shall be sold by the pharmacist in good faith as a medicine and not for the purpose of evading the provisions of this chapter. The pharmacist may, in his or her discretion, withhold sale to any person whom the pharmacist reasonably believes is attempting to purchase excepted compounds, mixtures, or preparations for the purpose of abuse.

( c ) The total quantity of controlled substance listed in Schedule V which may be sold to any one purchaser within a given 48-hour period shall not exceed 120 milligrams of codeine, 60 milligrams dihydrocodeine, 30 milligrams of ethyl morphine, or 240 milligrams of opium.

(d) Nothing in this section shall be construed to limit the kind and quantity of any controlled substance that may be prescribed, administered, or dispensed to any person, or for the use of any person or animal, when it is prescribed, administered, or dispensed in compliance with the general provisions of this chapter.

(4) The dextrorotatory isomer of 3-methoxy-n-methylmorphinan and its salts (dextromethorphan) shall not be deemed to be included in any schedule by reason of enactment of this chapter.

Florida Statutes, Chapter 893, “Florida Comprehensive Drug Abuse Prevention and Control Act”

7. What are the standards for the prescription of obesity drugs?

The prescription of medication for the purpose of enhancing weight loss should only be performed by physicians qualified by training and experience to treat obesity. All licensees are expected to abide by the following guidelines and standards in the utilization of any drug, any synthetic compound, any nutritional supplement, or herbal treatment, for the purpose of providing medically assisted weight loss.

(1) To justify the use of weight loss enhancers as set forth above, the patient must have a Body Mass Index (BMI) of 30 or above, or a BMI of greater than 27 with at least one comorbidity factor, or a measurable body fat content equal to or greater than 25% of total body weight for male patients or 30% of total body weight for women. The prescription of such weight loss enhancers is not generally appropriate for children. Any time such prescriptions are made for children, the prescribing physician must obtain a written informed consent from the parent or legal guardian of the minor patient in addition to complying with the other guidelines and standards set forth in this rule. BMI is calculated by use of the formula BMI = kg/m-squared.

(2) Physicians in Florida are prohibited from prescribing, ordering, dispensing or administering any weight loss enhancer that is both a serotonergic and anorexic agent unless the drug has been approved by the FDA specifically for use in weight loss management. Selective serotonin re-uptake inhibitors (SSRIs) that have not been approved by the FDA for weight loss may not be prescribed, ordered, dispensed or administered for such purposes.

(3) An initial evaluation of the patient shall be conducted prior to the prescribing, ordering, dispensing, or administering of any drug, synthetic compound, nutritional supplement or herbal treatment and such evaluation shall include an appropriate physical and complete history; appropriate tests related to medical treatment for weight loss; and appropriate medical referrals as indicated by the physical, history, and testing; all in accordance with general medical standards of care.

(a) The initial evaluation may be delegated to an appropriately educated and trained physician’s assistant or advanced registered nurse practitioner.

(b) If the initial evaluation required above is delegated to a physician’s assistant or to an advanced registered nurse practitioner, then the delegating physician must personally review the resulting medical records prior to the issuance of an initial prescription, order, or dosage.

(4) Prescriptions or orders for any drug, synthetic compound, nutritional supplement or herbal treatment for the purpose of assisting in weight loss must be in writing and signed by the prescribing physician. Initial prescriptions or orders of this type shall not be called into a pharmacy by the physician or by an agent of the physician. Even if the physician is registered as a dispensing physician, a hard copy of the written prescription must be maintained in the patient’s medical records for each time such weight loss enhancers are prescribed, ordered, dispensed or administered.

(5) At the time of delivering the initial prescription or providing the initial supply of such drugs to a patient, the prescribing physician must personally meet with the patient and personally obtain an appropriate written informed consent from the patient. Such consent must state that there is a lack of scientific data regarding the potential benefits versus potential risks of weight loss treatments. The written consent must also clearly state the need for dietary intervention and physical exercise as a part of any weight loss regimen. A copy of the signed informed consent shall be included in the patient’s permanent medical record.

(6) Each physician who is prescribing, ordering, or providing weight loss enhancers to patients must assure that such patients undergo an in-person re-evaluation within 2 to 4 weeks of receiving a prescription, order, or dosage. The re-evaluation shall include the elements of the initial evaluation and an assessment of the medical effects of the treatment being provided. Any patient that continues on a drug, synthetic compound, nutritional supplement or herbal treatment assisted weight loss program shall be re-evaluated at least once every 3 months.

(7) Each physician who prescribes, orders, dispenses or administers any drug, synthetic compound, nutritional supplement or herbal treatment for the purpose of assisting a patient in weight loss shall maintain proper medical records.

(8) Each physician who prescribes, orders, dispenses or administers weight loss enhancers for the purpose of providing medically assisted weight loss shall provide to each patient a legible copy of the Weight-Loss Consumer Bill of Rights. The physician shall also conspicuously post said document in those rooms wherein patients are evaluated for weight loss treatment.

(9) Any physician who advertises practice relating to weight loss or whose services are advertised by another person or entity shall be responsible for assuring that such advertising meets the requirements of the Florida Administrative Code. In addition, advertising of weight loss treatment shall be considered false, deceptive or misleading if it contains representations that:

(a) Promise specific results;

(b) Raise unreasonable expectations;

( c ) Claim rapid, dramatic, incredible or safe weight loss;

(d) State or suggest that diets or exercise are not required; or

(e) Suggest that weight loss is effortless or magical.

64 FL ADC 64B8-9.012

8. May registered interns, residents or fellows prescribe medicinal drugs?

(1) Resident physicians, interns or fellows employed by a hospital and engaged in an accredited training program may in the normal course of their employment prescribe medicinal drugs.

(2) Each resident physician, intern or fellow authorized by this rule to prescribe medicinal drugs shall utilize the Department issued registration number as his or her prescriber number. Any prescription written by such resident physician, intern or fellow shall have the registration/prescriber number printed thereon.

64 FL ADC 64B8-6.010

Copyright © Kern Augustine Conroy and Schoppmann, P.C. Used with permission.

Updated 2008