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FDA’s Drug Abuse Regulations
Community pharmacist to m edical service representative to instructor to assistant professorsuch is the capsuled step-by-step career of C. Eugene Watkins, assistant professor of pha rm acy ad m inistration at the Northeast Louisiana State College. The first candidate to receive a PhD from the University of Mississippi school of pharmacy (he earned his doctorate in pharmacy administration in 1964), Watkins holds a BS (1957) and an MS (1962) in pharmacy from the University of Tennessee. He also served as assistant director of the bureau of pharmaceutical services at the University of Mississippi.
written for the restricted drugs. It must be remembered, however, that a dual numbering system for narcotic and non-narcotic prescriptions can cause confusion in many pharmacies. The utilization of a third, separate and distinct numbering and filing system will only add to this confusion and increase the possibility for errors to occur. To lessen this possibility insofar as duplicate numbers are concerned, pharmacists can utilize a consecutive numbering system for all prescriptions. The prescription number could then be preceded by "N" for narcotic prescription, "D" (or some other suitable designation) for prescriptions for dangerous drugs and left without a letter for regular prescriptions. Such a procedure would allow the use of a consecutive numbering device and still provide a basis for separating the prescription orders into the proper files. Many practitioners write two or more prescription orders on the same blank. When the physician follows this practice and prescribes a restricted drug on the same blank with a non-restricted drug, the pharmacist will be forced to transcribe one of the prescription orders so that each may be filed in its proper place. Again, this alternative makes no special provision for recording sales of restricted drugs to other pharmacists or (continued on page 36)
NAME AND QUANTITY OF DRUG ()tJ
COMMENTS-TYPE OF TRANSACTION
Figure I-Suggested ledger sheet for recording transactions dealing with drugs restricted by H R 2
FDA's drug abuse regulations n December 18, Winton B. I{ankin, acting FDA commissioner, announced proposed procedural regulations to implement the Drug Abuse Control Amendments and the appointment of an advisory committee of medical experts who will assist FDA in determining which drugs should be covered under the new controls going into effect February 1, 1966. The procedural regulations published in the Federal Register on December 18 describe the records to be established and maintained and the information required in the initial inventory which must be taken on February 1, 1966. Rankin explained that the initial inventory must list the identity and quantity of all controlled drugs in finished form, including returned merchandise, orders prepared for shipment or delivery and all existing inventory in stock. This inventory is to be prepared by all pharmacies, hospitals, clinics, public health agencies, laboratories or research or educational institutions, practitioners licensed by law to prescribe or administer such drugs and persons engaged in manufacturing, wholesaling, jobbing, warehousing, transporting, distributing or otherwise disposing of such drugs covered by the amendments. Information required on the initial inventory and in continuous records must include the identity and quantity of each such drug received, the name and address of the person from whom the drug is received and the registration number, if any, assigned to any such person pursuant to the act. Also to be included in such continuing records shall be the identity and quantity of each such drug sold, delivered or otherwise disposed of, including the name
O
(continued on page 37) Vol. NS6, No.1, January 1966
11
FDA drug abuse regulations ( continued fro m page 11 )
and address of the person t o whom such drug was sold or delivered; the identity of any common carrier or t ransport ation fir m u sed in effecting such delivery; the registration number, if any ; the dat e su ch sale, delivery, or other disposit ion t ook place ; t he est ablish ed trade n ames for drugs containing a single active ingredient and " for those drugs (for which there is no established n ame) containing more tha n one active component, the established and t rade name for each active component." T he term "qu antity" means t he number of individual packages or containersand a st atement of a single u nit within the individual package resulting in the fo llowing t y pe of designation ("50 100-mg t ablets" or " 3 dozen 25-tablet bottles of lO-mg t ablets"). All such records are t o be readily available. According t o the proposed regulation s, records "will be considered inadequate or incomplete if such records are so intermingled with the records of products not covered by the Drug Abuse Control Amendments of 1965 that inspection of these records is impossible, impracticable or requires an unreasonable length of time. " D rugs covered by the act and regulations, u nless exempted, include any amount of t he following substances1. barbituric acid or any salt of barbituric acid 2. derivatives of barbituric acid which have been designated
as habit formin g 3. dextroamphetamine, levoamphetamine or amphetamine (racemic) or any salts of these The fo llowing is an exact listing published in the December 18 regulations which h as been ident ified as "a partial list of am phet amine product s. " (Since this was received as we were going to press, we have had no opportunity to verify it as to accuracy of spelling of trade names or categories.)Amphetamine phosphate-Actemin , Aktedron, Amphate, Mono· phos, Profetamine Phosphate , Racephen, Raphetamine Phosphate Amphetamine salts or optical isomers of amphetamine salts Amphetamine sulfate-Alentol, Amphoids-S, Benzedrine Sulfate, Linampheta , Psychoton, Simpamina Amphedrine Sulfate Dextroamphetamine carboxymethylcellulose salt Dextroamphetamine hyd rochloride Dextroamphetamine phosphate-Dextro-Profetamine Dextroamphetamine sulfate-Adrizine, Am-Dex, D-Amfetasul, Amitrene, Amphedrine , Ampheres, Amphex , Amsustain, D-Ate Ph. 747 , Betafedrine , d-Betaphedrine, Cendex Cenules, D-Citramine, Cradex, Dadex, D.A.S., Dexalone, Dexamphetam ine, Dexedrine, Dex-OB, Dex-Sule, Dexten, Dextrosule, Diocurb, Domafate, Evrodex, Hetamine, Lowedex, Maxiton, Medex, Nilox, Obesedrin, Obesonil, Pellcaps, Pomadex, Simpamina-D, Sympamin, Tydex, Zamitan Plateau Dextroamphetamine tannate-Tanphetamin, Synatan Dibasic amphetamine phosphate-Bar-Dex Dibasic dextroamphetamine phosphate Levoamphetamine-Ad-Nil, Amphedrine-M, Levabo, Levam · phetamine , Levonor Levoamphetamine succinate-Cydi'il Controls m ay also be est ablished for other drugs wit h a pot ential for abuse; these may include LSD -25 and other hallucinogenic drugs, certain t ran quilizers an d depressant drugs and other stimulants . In determining whether a drug has stimulant effect , the FDA commissioner will reportedly consider , among other relevant fact ors, whether there is subst antial evidence that the drug m ay produce any of the following1. Extended wakefulness 2. Elation, exhilaration or euphoria (exaggerated sense of
well-being)
3. Alleviation of fatigue 4. Insomnia, irritability or agitation 5. Apprehension or anxiety 6. Flight of ideas, loquacity, hypomania or transient deliria In deter mining wheth er a drug has depressant effect on the central nervous system, t he commissioner will, according to the regulations, consider, among other relevant fact ors, whether the substance may produce any of th e following1. Calming effect or relief of emotional tension or anxiety 2. Drowsiness, sedation , sleep, stupor, coma or general anesthesia 3. Increase of pain threshold 4. Mood depression or apathy 5. Disorientation, confusion or loss of mental acuity
In determining wh ether a drug is h abit-forming, the commissioner will consider whether t here is substantial eviden ce that t he drug may produce any of t he following1. A psychological or phys ical dependence on the drug (compulsive use) 2. Euphoria (exaggerated sense of well-being) 3. Personality changes 4. Transient psychoses, deliria , twilight state or hallucinoses 5. Chronic brain syndrome 6. Increased tolerance or a need or desire to increase the drug dosage 7. Physical dependence or a psychic dependence evidenced by a de sire to continue taking the drug for the sense of improved well-being that it engenders 8. Pharmacological activity sim ilar or identical to that of drugs previously designated as habit-forming To det ermine whet her or not a drug may h ave hallucinogenic effect , the commissioner will consider if there is substantial evidence that it may produce h allucinations, illusions. delusions or alterations of any of t he fo llowing1. Orientation with respect to time or place 2. Consciousness , as evidenced by confused states, dreamlike revivals of past traumatic events or childhood
memories 3. Sensory perception, as evidenced by visual illusions,
syn esthesia , distortion of space and perspective 4. Motor coordination 5. Mood and affectivity, as evidenced by anxiety, euphoria, hypomania, ecstasy, autistic withdrawal 6. Ideation, as evidenced by flight of ideas, ideas of reference, impairment of concentration and intelligence 7. Personality, as evidenced by depersonalization and derealization , impairment of conscience and of acquired social and cultural customs To determine which drugs, in addi t ion t o barbiturates and am ph etamines, should be covered under the act , FDA has n amed an advisory committee on abuse of depressant and stimulant drugs, consisting of Frederick E. Shideman, University of M innesot a school of medicine; H enry Brill, MD, Pilgrim Stat e H ospital, New York; J ohn A. Clau sen , Universit y of Californi a; Harris Isbell, M D , University of K entucky medical center ; Walter M odell , M D , Cornell Universit y medical college; E liot Herman Rodnick, University of California, Los Angeles; Klaus R. Unna, M D , University of Illinois college of medicine, and Cy rus B . M axwell, MD , FDA Bureau of Medicine, executive secretary of the committee. Interested part ies are invited t o submit information on over-the-counter drugs and combinations containing stimulant or depressant drugs which should be exem pted because they do not have a pot ential fo r abuse. Comment h as also been invited on whether or not a symbol (recommended by APHA) should be required on the labels of drugs subject t o control. Comment must be submitted in writing by J anuary 18, 1966. t o the H earing Clerk, D epartment of H ealt h, E ducation and Welfare, R oom 5440,330 Independence Avenue N .W., Washingt on , D.C. 20201. Comments concerning any addition al trade names that m ay be list ed are part icularly desired . • Vol . NS6, No . 1,
January 1966
37
written for the restricted drugs. It must be remembered, however, that a dual numbering system for narcotic and non-narcotic prescriptions can cause confusion in many pharmacies. The utilization of a third, separate and distinct numbering and filing system will only add to this confusion and increase the possibility for errors to occur. To lessen this possibility insofar as duplicate numbers are concerned, pharmacists can utilize a consecutive numbering system for all prescriptions. The prescription number could then be preceded by "N" for narcotic prescription, "D" (or some other suitable designation) for prescriptions for dangerous drugs and left without a letter for regular prescriptions. Such a procedure would allow the use of a consecutive numbering device and still provide a basis for separating the prescription orders into the proper files. Many practitioners write two or more prescription orders on the same blank. When the physician follows this practice and prescribes a restricted drug on the same blank with a non-restricted drug, the pharmacist will be forced to transcribe one of the prescription orders so that each may be filed in its proper place. Again, this alternative makes no special provision for recording sales of restricted drugs to other pharmacists or (continued on page 36)
NAME AND QUANTITY OF DRUG ()tJ
COMMENTS-TYPE OF TRANSACTION
Figure I-Suggested ledger sheet for recording transactions dealing with drugs restricted by H R 2
FDA's drug abuse regulations n December 18, Winton B. I{ankin, acting FDA commissioner, announced proposed procedural regulations to implement the Drug Abuse Control Amendments and the appointment of an advisory committee of medical experts who will assist FDA in determining which drugs should be covered under the new controls going into effect February 1, 1966. The procedural regulations published in the Federal Register on December 18 describe the records to be established and maintained and the information required in the initial inventory which must be taken on February 1, 1966. Rankin explained that the initial inventory must list the identity and quantity of all controlled drugs in finished form, including returned merchandise, orders prepared for shipment or delivery and all existing inventory in stock. This inventory is to be prepared by all pharmacies, hospitals, clinics, public health agencies, laboratories or research or educational institutions, practitioners licensed by law to prescribe or administer such drugs and persons engaged in manufacturing, wholesaling, jobbing, warehousing, transporting, distributing or otherwise disposing of such drugs covered by the amendments. Information required on the initial inventory and in continuous records must include the identity and quantity of each such drug received, the name and address of the person from whom the drug is received and the registration number, if any, assigned to any such person pursuant to the act. Also to be included in such continuing records shall be the identity and quantity of each such drug sold, delivered or otherwise disposed of, including the name
O
(continued on page 37) Vol. NS6, No.1, January 1966
11
FDA drug abuse regulations ( continued fro m page 11 )
and address of the person t o whom such drug was sold or delivered; the identity of any common carrier or t ransport ation fir m u sed in effecting such delivery; the registration number, if any ; the dat e su ch sale, delivery, or other disposit ion t ook place ; t he est ablish ed trade n ames for drugs containing a single active ingredient and " for those drugs (for which there is no established n ame) containing more tha n one active component, the established and t rade name for each active component." T he term "qu antity" means t he number of individual packages or containersand a st atement of a single u nit within the individual package resulting in the fo llowing t y pe of designation ("50 100-mg t ablets" or " 3 dozen 25-tablet bottles of lO-mg t ablets"). All such records are t o be readily available. According t o the proposed regulation s, records "will be considered inadequate or incomplete if such records are so intermingled with the records of products not covered by the Drug Abuse Control Amendments of 1965 that inspection of these records is impossible, impracticable or requires an unreasonable length of time. " D rugs covered by the act and regulations, u nless exempted, include any amount of t he following substances1. barbituric acid or any salt of barbituric acid 2. derivatives of barbituric acid which have been designated
as habit formin g 3. dextroamphetamine, levoamphetamine or amphetamine (racemic) or any salts of these The fo llowing is an exact listing published in the December 18 regulations which h as been ident ified as "a partial list of am phet amine product s. " (Since this was received as we were going to press, we have had no opportunity to verify it as to accuracy of spelling of trade names or categories.)Amphetamine phosphate-Actemin , Aktedron, Amphate, Mono· phos, Profetamine Phosphate , Racephen, Raphetamine Phosphate Amphetamine salts or optical isomers of amphetamine salts Amphetamine sulfate-Alentol, Amphoids-S, Benzedrine Sulfate, Linampheta , Psychoton, Simpamina Amphedrine Sulfate Dextroamphetamine carboxymethylcellulose salt Dextroamphetamine hyd rochloride Dextroamphetamine phosphate-Dextro-Profetamine Dextroamphetamine sulfate-Adrizine, Am-Dex, D-Amfetasul, Amitrene, Amphedrine , Ampheres, Amphex , Amsustain, D-Ate Ph. 747 , Betafedrine , d-Betaphedrine, Cendex Cenules, D-Citramine, Cradex, Dadex, D.A.S., Dexalone, Dexamphetam ine, Dexedrine, Dex-OB, Dex-Sule, Dexten, Dextrosule, Diocurb, Domafate, Evrodex, Hetamine, Lowedex, Maxiton, Medex, Nilox, Obesedrin, Obesonil, Pellcaps, Pomadex, Simpamina-D, Sympamin, Tydex, Zamitan Plateau Dextroamphetamine tannate-Tanphetamin, Synatan Dibasic amphetamine phosphate-Bar-Dex Dibasic dextroamphetamine phosphate Levoamphetamine-Ad-Nil, Amphedrine-M, Levabo, Levam · phetamine , Levonor Levoamphetamine succinate-Cydi'il Controls m ay also be est ablished for other drugs wit h a pot ential for abuse; these may include LSD -25 and other hallucinogenic drugs, certain t ran quilizers an d depressant drugs and other stimulants . In determining whether a drug has stimulant effect , the FDA commissioner will reportedly consider , among other relevant fact ors, whether there is subst antial evidence that the drug m ay produce any of the following1. Extended wakefulness 2. Elation, exhilaration or euphoria (exaggerated sense of
well-being)
3. Alleviation of fatigue 4. Insomnia, irritability or agitation 5. Apprehension or anxiety 6. Flight of ideas, loquacity, hypomania or transient deliria In deter mining wheth er a drug has depressant effect on the central nervous system, t he commissioner will, according to the regulations, consider, among other relevant fact ors, whether the substance may produce any of th e following1. Calming effect or relief of emotional tension or anxiety 2. Drowsiness, sedation , sleep, stupor, coma or general anesthesia 3. Increase of pain threshold 4. Mood depression or apathy 5. Disorientation, confusion or loss of mental acuity
In determining wh ether a drug is h abit-forming, the commissioner will consider whether t here is substantial eviden ce that t he drug may produce any of t he following1. A psychological or phys ical dependence on the drug (compulsive use) 2. Euphoria (exaggerated sense of well-being) 3. Personality changes 4. Transient psychoses, deliria , twilight state or hallucinoses 5. Chronic brain syndrome 6. Increased tolerance or a need or desire to increase the drug dosage 7. Physical dependence or a psychic dependence evidenced by a de sire to continue taking the drug for the sense of improved well-being that it engenders 8. Pharmacological activity sim ilar or identical to that of drugs previously designated as habit-forming To det ermine whet her or not a drug may h ave hallucinogenic effect , the commissioner will consider if there is substantial evidence that it may produce h allucinations, illusions. delusions or alterations of any of t he fo llowing1. Orientation with respect to time or place 2. Consciousness , as evidenced by confused states, dreamlike revivals of past traumatic events or childhood
memories 3. Sensory perception, as evidenced by visual illusions,
syn esthesia , distortion of space and perspective 4. Motor coordination 5. Mood and affectivity, as evidenced by anxiety, euphoria, hypomania, ecstasy, autistic withdrawal 6. Ideation, as evidenced by flight of ideas, ideas of reference, impairment of concentration and intelligence 7. Personality, as evidenced by depersonalization and derealization , impairment of conscience and of acquired social and cultural customs To determine which drugs, in addi t ion t o barbiturates and am ph etamines, should be covered under the act , FDA has n amed an advisory committee on abuse of depressant and stimulant drugs, consisting of Frederick E. Shideman, University of M innesot a school of medicine; H enry Brill, MD, Pilgrim Stat e H ospital, New York; J ohn A. Clau sen , Universit y of Californi a; Harris Isbell, M D , University of K entucky medical center ; Walter M odell , M D , Cornell Universit y medical college; E liot Herman Rodnick, University of California, Los Angeles; Klaus R. Unna, M D , University of Illinois college of medicine, and Cy rus B . M axwell, MD , FDA Bureau of Medicine, executive secretary of the committee. Interested part ies are invited t o submit information on over-the-counter drugs and combinations containing stimulant or depressant drugs which should be exem pted because they do not have a pot ential fo r abuse. Comment h as also been invited on whether or not a symbol (recommended by APHA) should be required on the labels of drugs subject t o control. Comment must be submitted in writing by J anuary 18, 1966. t o the H earing Clerk, D epartment of H ealt h, E ducation and Welfare, R oom 5440,330 Independence Avenue N .W., Washingt on , D.C. 20201. Comments concerning any addition al trade names that m ay be list ed are part icularly desired . • Vol . NS6, No . 1,
January 1966
37